The ICMA Information Package on Medical Abortion
Information for health care providers / Updated in 2013
An estimated 21.6 million women globally had an unsafe abortion in 2008, resulting in 47,000 deaths, largely among young women ,  . Many more suffer injury and complications and an estimated 5 million women per year are hospitalized in developing countries for complications of unsafe abortion . Almost all these deaths and injuries are entirely preventable or treatable.
Unsafe abortion was recognized as a major public health issue at the International Conference on Population and Development (ICPD) in Cairo in 1994. Its Programme of Action called for:
Health professionals have played a significant role in promoting women’s access to safe abortion in many parts of the world. Individual health professionals in many countries have spoken out courageously on the need to prevent maternal deaths from unsafe abortions and have provided leadership in providing safe abortion services. Statements issued by many national and international organizations affirm the responsibility of health professionals in the provision of abortion services. For example, the Ethical Guidelines regarding induced abortion for non-medical reasons issued by the International Federation of Gynecology and Obstetrics (FIGO) note that:
“ .. after appropriate counseling, a woman has the right to have access to medical or surgical induced abortion, and that the health care service has an obligation to provide such services as safely as possible.” 
Medical abortion, the termination of pregnancy through the use of a drug or a combination of drugs, has revolutionized abortion procedures in the first trimester, because it is not dependent on surgical intervention. Medical abortion means that women can now have a choice between abortion methods. Because medical abortion is a simple process which happens in the woman’s body, it has the potential to expand access to abortion provided by clinicians and mid-level providers who may or may not have training in aspiration methods of abortion. Women in early pregnancy can take the medication(s) and have their abortion at home if they prefer to do so; this is safest if they have access to appropriate back-up medical services if needed.
Mifepristone is now available in some 50 countries and the list is growing. More than tens of millions of women in China (possibly as many as 200 million) and over four million in the rest of the world have used medical abortion to terminate a pregnancy safely and effectively . In dozens more countries, misoprostol alone is also being used for safe pregnancy termination but the effectiveness of the misoprostol-alone regimen is somewhat lower than that of the mifepristone-misoprostol regimen.
In 2005, WHO added mifepristone and misoprostol to its complementary Model List of Essential Medicines for countries where abortion is “permitted under national law and culturally acceptable”. The WHO Model List of Essential Medicines contains those medicines which are considered to satisfy the priority health needs of the population of developing countries, and which have been selected on the basis of their efficacy, safety and cost-effectiveness .
Provider knowledge and acceptance are important keys to expanding access to medical abortion services in all countries. Experience in Europe shows that providers who favor medical abortion get a much larger proportion of women opting for medical abortion, while providers whose attitudes are unfavorable tend to have fewer patients who choose the method . Although some potential providers have expressed concerns, the provision of medical abortion is not complicated – even in the second trimester – and does not require extensive training or high-technology back-up facilities . However, it does require that patients have access to appropriate medical/surgical back-up services when they are needed.
Lack of adequate information on medical abortion may also influence providers’ willingness to offer the method. In settings where abortion is legally restricted or where information has been inadequate, providers may have administered incorrect dosages, resulting in unnecessary side-effects or incomplete or failed abortions, which in turn may discourage them from continuing to provide the method .
This Information Package aims to help at bridging the information gap on medical abortion among health providers. This chapter is presented in six sections. The first section provides basic information on dosages and regimens, medical eligibility and screening protocols. The second section focuses on basic requirements in a health facility for providing medical abortion services or for back-up services when medical abortion is provided in non-clinical settings. The third section is on information provision and counseling, which are important components of all abortion services. The fourth section is about training for providing medical abortion. The fifth section discusses promoting access to medical abortion in health systems. The last section summarizes what is happening in settings where, although abortion is legally restricted, medical abortion is also being used extensively.
This chapter of the ICMA Information Package has borrowed extensively from publications and reports produced by the World Health Organization (WHO). These documents include the latest abortion guidelines, fact sheets and policy briefs on providing safe abortion services worldwide and documents specifically addressing clinical issues related to medical abortion , .
|2. Medical abortion: technical issues|
1. Drugs used for medical abortion
Mifepristone is an antiprogestin licensed for pregnancy termination in many countries around the world. It blocks the action of progesterone in the body resulting in the withdrawal of progesterone support to the endometrium (decidua), enhanced uterine contractility, and the detachment of the implanted embryo. In addition, it causes marked softening and dilation of the cervix. Mifepristone is typically used with a prostaglandin (misoprostol) to further enhance uterine contractions for maximum efficacy.
Misoprostol is a synthetic prostaglandin developed for the treatment and prevention of gastric ulcers. It acts as a uterotonic and cervical primer, causing strong contractions that lead to expulsion of the products of conception. (The process is very much like a spontaneous abortion or miscarriage.) Misoprostol is currently the favored prostaglandin because of its safety, low cost, wide availability, stability at room temperature, and easy administration. Misoprostol may be administered orally, vaginally, buccally, or sublingually. In settings where mifepristone is not available or too expensive, misoprostol can be used on its own although higher doses may be needed, and efficacy is lower, than when using the combination regimens of mifepristone and misoprostol. In addition, misoprostol can also be used alone for pregnancy termination in the second trimester.
Methotrexate is a folic acid antagonist that interferes with DNA synthesis. In some countries where mifepristone is not available, methotrexate is used in combination with misoprostol. Methotrexate is not recommended by the World Health Organization (WHO) for inducing abortion because it causes fetal malformations if the pregnancy continues . However, this risk is small and methotrexate plus misoprostol has been used successfully for years in several countries including Canada and Colombia, as well as in the USA prior to the approval of mifepristone. The combination of methotrexate with misoprostol is less effective than the combination of mifepristone with misoprostol, and it involves a more prolonged and unpredictable abortion process. However, the methotrexate/misoprostol combination has been shown to be more effective than misoprostol-alone for early abortion .
Abortion is one of the safest medical procedures but, as with any medical procedure, there is always a small risk of complications. It is always important to remember that medical abortion is far safer than many of the dangerous methods of abortion women subject themselves to when safe abortion services are not available or accessible. The experience with medical abortion until now has demonstrated that it is safe when provided by trained health-care professionals with adequate back-up services.
When women with pregnancies of up to 63 days since the beginning of their last menstrual period (LMP) are treated with 200 mg of mifepristone followed 24–48 hours later by 400-800 micrograms of vaginal, sublingual, or buccal misoprostol, typically 95-98% of them have complete abortions , , , . Failure (recourse to surgical evacuation) may be the result of ongoing pregnancy, incomplete expulsion, heavy bleeding, the provider deeming it medically necessary or patient request. Factors that may impact success include gestational age of pregnancy, regimen, provider experience, and visit schedule. The need for uterine evacuation for hemostatic purposes varies between studies from 0.35% to 2.5%, and is significantly higher among women at gestations of 49 days LMP or more compared to earlier pregnancies (3.3% vs 1.5%; p=0.0193) . About 1-2 per 1000 women treated require blood transfusion. Studies that have measured hemoglobin concentrations suggest a decrease, which is often significant, one to two weeks after treatment, but the values usually return to normal afterwards .
The most common problems reported at follow-up or unscheduled visits are continued pain and vaginal bleeding . Among women whose pregnancy was terminated, about half of those with an empty uterine cavity, and >70% of those with missed abortion or debris found at ultrasound examination, continued to bleed beyond 12 days. According to a review , the overall frequency of diagnosed and/or treated infection reported after medical abortion was <1% (0.92%, n=46,421). Thus, infections after medical abortion seem to be rare, and possibly occur less often than after vacuum aspiration .
In general, bleeding is most abundant around the time of expulsion. Emergency care and facilities for surgical intervention should be available locally or through a referral mechanism with established linkages. Back-up services should include uterine evacuation, fluid replacement and blood transfusion, but they do not need to be available at the site providing medical abortion in the first trimester. (See below 7. Management of side-effects and complications.)
There is no documentation of greater blood loss with medical abortion than with surgical intervention. However, women undergoing a medical abortion will observe much more blood loss than women who opt for a surgical one. Heavy bleeding (though affecting only a small proportion of women) sometimes occurs with medical abortion, occasionally weeks after the procedure.
Research has shown that medical abortion is highly acceptable to women in a variety of settings . Studies in a number of countries around the globe have shown the vast majority of women to be “satisfied” or “very satisfied” with their medical abortions , , , , , , ,  . It is important to keep in mind that the context in which the abortion is provided may have a strong impact on how a woman views her experience.
There are very few contraindications to medical abortion. When using a combination of mifepristone and misoprostol they include:
Caution and clinical judgement are required if the woman:
Anemia need not be regarded as a contraindication. However, anemia detected at the time of abortion should be treated. Average blood loss after medical abortion may be more than that in surgical abortion, and the incidence of heavy bleeding may be higher and the duration of bleeding longer , ,  .
Asthma is not a contraindication for medical abortion.
Breastfeeding . It is likely that mifepristone passes into breast milk, but no clinical effects have been reported. Small amounts of misoprostol also enter breast milk soon after administration, but it is not known whether this could have any effect on the infant. As misoprostol levels decline rapidly, it has been recommended that misoprostol should be taken immediately after a feed .
HIV-positive women . Providers now have more experience providing medical abortion in countries with high HIV prevalence and there is no indication of increased negative outcomes in these settings. Most abortion studies do not exclude HIV-positive women and there is no reason to believe that treatment outcomes in these women would be any different from those in HIV-negative women.
Insulin-dependent diabetes or thyroid disorder . There is no evidence that medical abortion causes any particular problems in women with these conditions.
IUD . If a woman has an intrauterine device (IUD) in place, this should be removed prior to use of medical abortion.
Multiple pregnancy (current gestation) . There is no evidence that the failure rate of medical abortion is increased or that a different dosage regimen is required in the case of multiple pregnancy.
Obesity . There is no evidence that the failure rate of medical abortion is increased or that a different dosage regimen is required in obese women .
Previous cesarean section . There is evidence from one study that the safety and efficacy of early medical abortion are unaffected by previous cesarean section  .
Smoking . There is no evidence of interaction between the risks of smoking and medical abortion. However, smoking contributes to cardiovascular risk and this factor should be considered when assessing a woman’s overall suitability for medical abortion.
Uterine malformations (congenital and acquired); previous cervical surgery . There is no evidence that these represent contraindications; rather, medical abortion may be preferred with these conditions due to the increased difficulty of surgical procedures.
4. Regimens with mifepristone and misoprostol
Labeling information for mifepristone states that the drug is indicated for the medical termination of intrauterine pregnancy up to 49-63 days LMP, depending on the country and the route of prostaglandin analogue. Mifepristone followed by repeated doses of a prostaglandin analogue (most commonly misoprostol) is also licensed and widely used in Europe for abortion in later pregnancies. Studies carried out in many different countries provide evidence of the safety of medical abortion up to 24 weeks of gestation , , , , , .
However, it should be noted that while the dose of mifepristone does not change, the dose of misoprostol does need to be modified for different stages of pregnancy. A higher total dose is often needed in late first trimester compared to early first trimester. During the second trimester, due to increased sensitivity of the uterine musculature to prostaglandins, it is wise to lower the doses to avoid hyperstimulation and the risk of uterine rupture; doses should also be lowered in the case of a uterine scar such as from a previous cesarean section. The combined mifepristone–misoprostol regimen can thus be used throughout pregnancy provided that the dosage of misoprostol is adjusted ,  .
In many countries, mifepristone is licensed for use as a single oral dose of 600 mg. However, a dose of 200 mg has been shown to be as effective as the 600 mg dose and can greatly reduce costs . In Scandinavia, another drug is in the process of being approved for medical abortion.
The following regimens and dosages are based on the latest recommendations from the World Health Organization .
Up to 63 days LMP
The recommended regimen is 200 mg of mifepristone administered orally, followed 24–48 hours later by 800 micrograms of misoprostol administered vaginally, sublingually or buccally or 400 micrograms of misoprostol administered orally. With gestations up to 7 weeks (49 days) misoprostol may be administered by vaginal, sublingual, buccal or oral routes. After 7 weeks of gestation, oral administration of misoprostol should not be used.
9-12 weeks (63-84 days) LMP
The recommended regimen is 200 mg of mifepristone administered orally, followed 36–48 hours later by 800 micrograms of vaginal misoprostol, administered in a health facility. A maximum of 4 additional doses of 400 micrograms misoprostol may be administered at 3-hour intervals, vaginally or sublingually, until expulsion of the products of conception.
After 12 weeks (>84 days) LMP
The recommended regimen for pregnancies between 12 and 24 weeks is 200 mg of mifepristone administered orally, followed 36–48 hours later by 400 micrograms of oral misoprostol or 800 micrograms of vaginal misoprostol, administered in a health facility. Subsequent misoprostol doses should be 400 micrograms administered either vaginally or sublingually, every 3 hours up to four further doses.
For pregnancies beyond 24 weeks, the dose of misoprostol should be reduced due to the greater sensitivity of the uterus to prostaglandins; the lack of clinical studies prohibits specific dosing recommendations.
Most medical abortion regimens call for misoprostol to be administered 24-48 hours following mifepristone. However, studies have demonstrated that, in early pregnancy termination, misoprostol can be administered 12-72 hours after mifepristone with method success , . Expanding the time frame for misoprostol administration might increase the regimen’s flexibility and make it more accommodating for both women’s and clinics’ schedules.
Route of misoprostol
For buccal and sublingual administration, women are typically advised to hold the pills in their cheeks (buccal) or under their tongue (sublingual) for 20-30 minutes and then swallow any remaining fragments. Buccal, sublingual, and vaginal administrations have been shown to be highly effective up to 9 weeks’ LMP , , , , , , , . Compared to vaginal administration, sublingual and buccal misoprostol are associated with higher rates of gastrointestinal side-effects and diarrhea, respectively . Vaginal administration of misoprostol is more effective and associated with fewer side-effects than oral administration of the same dose , , , .
4.1. Regimens with misoproston alone
Misoprostol used alone is a promising alternative in settings where mifepristone is unaffordable or not available. However, without mifepristone, a higher total dose of misoprostol, often with repeat doses of 800 micrograms, may be needed, and it is less effective than regimens combining it with mifepristone. In addition, the abortion process can be more painful and side-effects such as diarrhea and chills may be more severe , with side-effect incidence depending on the route of administration. There is also a higher rate of failed abortion and continuing live pregnancy.
The recommended regimen is 800 micrograms administered vaginally or sublingually. Up to three repeat doses of 800 micrograms can be administered at intervals of at least 3 hours, but for no longer than 12 hours. This regimen has been shown to be 75-90% effective. Sublingual administration is less effective than vaginal administration unless given every 3 hours, and this regimen has higher rates of gastrointestinal side-effects , ,  . Oral administration is less effective and therefore not recommended.
Misoprostol used alone is effective after 12 weeks LMP but the time to complete abortion is usually longer than when used in conjunction with mifepristone. The recommended dose is 400 micrograms administered vaginally or sublingually every 3 hours for up to 5 doses , . Vaginal administration is more effective than sublingual, especially for nulliparous women. For pregnancies beyond 24 weeks gestation, the dose of misoprostol should be reduced due to sensitivity of the uterus to prostaglandins; a lack of clinical evidence prohibits specific dosing recommendations.
Women should be informed about the possible teratogenic effects of methotrexate and, if given, both the woman and provider need to be certain that there is no ongoing pregnancy following treatment. Methotrexate is available in oral tablets and as a solution that can be injected intramuscularly in a dose relative to the woman’s body surface area.
Up to 9 weeks (63 days) LMP
The most common regimen is 50 mg methotrexate administered orally, followed 5-7 days later by 800 micrograms misoprostol administered vaginally. The misoprostol dose is usually repeated after 24 hours if the abortion has not occurred.
Where both medical and surgical abortion are offered, every woman with an unwanted pregnancy who is considering abortion should receive information about both methods in a way that she can understand, to allow her to make her own decision about which method to choose. Most women have already made a decision before coming to the clinic. Nevertheless, some women require additional time and support in reaching a decision. Both counseling and the abortion procedure should be provided without undue delay. Privacy is essential and women should be free to choose to be counseled alone or with a partner, parent, or friend.
Those providing abortion counseling must be familiar with their local legal framework regarding consent by young women below the legal age of consent. However, no woman should be coerced into involving her parents or partner when she is unwilling to do so.
Ideally, pre-abortion counseling should include discussion about future contraceptive needs. In helping a woman to choose the most appropriate contraceptive method for the future, it may be useful to explore the circumstances in which the unwanted pregnancy occurred. The goal of contraceptive counseling and provision in the context of abortion care is to begin the chosen method immediately after the abortion. If the woman chooses a method that cannot be started immediately should be encouraged to use condoms in the meantime.
Confirmation of pregnancy and estimation of length of gestation
In most cases, pregnancy can be confirmed and its length estimated on the basis of the woman’s history and a physical examination. Occasionally, laboratory tests may be needed when the typical signs of pregnancy are not clearly present and the health-care provider is unsure whether the woman is pregnant.
Clinical assessment and laboratory investigations prior to medical abortion
As with any method of abortion, clinical history-taking should serve to identify contraindications and to identify risk factors for complications. History-taking should follow standard clinic practice in terms of personal and gynecological history, sexually transmitted infections (STIs), and violence or coercion. If needed, resources are available for guidance on these matters.
Basic routine measurements (pulse, blood pressure, and temperature) are useful as a baseline.
There are no laboratory tests that are essential before medical abortion. However, tests such as hemoglobin level, blood group and rhesus (Rh) typing, and screening for hepatitis, human immunodeficiency virus (HIV), and STIs (such as chlamydia and gonorrhea), may be offered on the basis of individual risk factors, available resources, and local standard of care.
Testing of Rh status often depends on local rates and practice. For pregnancies up to 63 days gestation, the theoretical risk of maternal Rh sensitization is very low; there is no evidence that sensitization occurs at this stage of pregnancy. Thus, determination of blood group and Rh status and the offer of anti-D prophylaxis to Rh-negative women are not considered prerequisites for early medical abortion in many places, including Sweden. In settings where the prevalence of Rh-negative status is high, and where resources permit, offering Rh typing and anti-D prophylaxis may be worthwhile as precautionary components of medical abortion care.
Mifepristone and misoprostol are ineffective treatments for ectopic pregnancy which, if present, will continue to grow. Therefore, health-care staff must be particularly alert to clinical signs of ectopic pregnancy, such as a uterus that feels smaller than expected according to the date of the woman’s LMP, cervical motion tenderness, or the presence of an adnexal mass on pelvic examination. Women should seek medical advice promptly if they experience symptoms and signs that may indicate ectopic pregnancy, such as abdominal pain on one side.
Where clinical features (e.g. history of ectopic pregnancy or STI, discrepancy between menstrual dates and vaginal examination findings, vaginal bleeding, or pelvic pain) raise suspicion of an ectopic pregnancy, appropriate tests should be done, such as pelvic ultrasound and serial human chorionic gonadotropin (hCG) measurements. If ectopic pregnancy is diagnosed or strongly suspected, the woman should be transferred to an appropriate gynecology service for continuing care.
Treatment with mifepristone and misoprostol typically involves up to two or three clinic visits.
A single 200 mg tablet of mifepristone is taken orally. Depending on the national law and the protocol, and provided the pregnancy is of less than 9 weeks’ duration, the woman is typically given the choice of either taking misoprostol at home, or coming back to the clinic to take misoprostol under medical supervision.
Pain relief during medical abortion
The abortion process causes pain. It is most likely to be felt in the first hours after administration of misoprostol, when the gestational sac/embryo is being expelled from the uterus. Studies have shown that women feel less pain if they are older, have been pregnant before or are in the early stages of pregnancy , , . However, none of these factors is sufficiently predictive to be useful in the management of individual cases.
The perception of pain and request for relief vary greatly from one individual to another and between cultures. Pain is also dependent on duration of pregnancy. Health-care providers should make adequate analgesia easily available to all women who request it during medical abortion. Examples of commonly used preparations are: nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen 200 mg, or paracetamol 500–1000 mg. Ibuprofen has been shown to be more effective than paracetamol . In cases of severe pain, codeine 30–40 mg or other narcotic drug may be added to either of the above-mentioned treatments.
Most women report some amount of pain and around half perceive a need for analgesia. Pain rarely indicates the need for surgical intervention and usually improves rapidly following expulsion. Methods for relieving pain include hot water bottle or heating pad, sitting or lying comfortably, support of friends and/or family, soothing music, television, and/or tea (where available), paracetamol, and NSAIDs such as ibuprofen.
All women with a successful medical abortion will experience some amount of vaginal bleeding. The total blood loss is related to gestational age . Bleeding may be heavier and last longer than a normal period, but it rarely adversely affects hemoglobin levels. Bleeding is often heaviest in the first 3-6 hours after prostaglandin administration and typically lasts for about a week, although it can last up to a month in some women. Women should be given clear instructions on what to expect regarding bleeding and when and where they should seek additional care if needed.
Misoprostol can sometimes cause temperature elevations, but they usually do not last for longer than about two hours. A fever that persists over several days or that starts days after prostaglandin administration could indicate an infection. Women should be instructed to contact the clinic if fever lasts longer than four hours or begins more than a day after misoprostol administration.
Nausea and vomiting
Approximately half of all women undergoing medical abortion will experience nausea and vomiting may occur in less than one third. These symptoms are usually related to pregnancy as well as to the abortifacient medications. They may appear or increase following mifepristone administration and typically decrease within hours after expulsion of the products of conception.
Transient diarrhea occurs in less than one fourth of all women after misoprostol intake. Because of the brevity, treatment is rarely needed.
Headache and faintness or dizziness
These symptoms occur in less than one fourth of women. They are usually self-limited, resolve spontaneously, and are managed symptomatically if needed.
Second visit (if taking misoprostol in the clinic)
Some protocols require women to stay in the clinic after taking misoprostol, but this is not medically necessary. In the 4-6 hours after misoprostol use, almost two thirds of women, depending on gestational age, will expel the products of conception . If abortion does not occur within the observation period, the woman can go home to abort.
In first-trimester pregnancies of more than 9 weeks’ duration, 800 micrograms vaginal misoprostol are administered in a health facility 36-48 hours after mifepristone. Up to 4 additional doses of 400 micrograms misoprostol may be administered at 3-hour intervals, vaginally or sublingually. The woman is typically kept under observation until several hours after she expels the products of conception.
All women should be given:
It is important to confirm that the pregnancy has indeed been terminated after medical abortion. If expulsion of the products of conception is confirmed by a provider or by the woman herself before or more usually after administration of the prostaglandin, further follow-up is not absolutely necessary. Otherwise, a follow-up visit should be arranged about 2 weeks after the administration of misoprostol, at the convenience of the woman.
Alternatives to in-person follow-up
Returning to the clinic for a visit can be both costly and inconvenient for many women. Several alternatives to in-person follow-up are possible and may reduce the need for unnecessary clinic visits , , . Research indicates that women can be taught to identify the signs and symptoms of infection, incomplete abortion, and continuing pregnancy and to determine for themselves whether or not they need to seek additional medical care. A crucial component of alternative follow-up is thoroughly educating all medical abortion patients regarding normal bleeding and pain, ongoing pregnancy symptoms, recognizing the passage of pregnancy tissue, proper use of a thermometer, and understanding warning signs for ectopic pregnancy. Telephone follow-up initiated by either clinic or patient may also help to identify any problematic symptoms. Home urine pregnancy tests (either standard low-sensitivity tests or one designed to report actual hCG levels) could be helpful in verifying complete abortion and signaling women as to whether or not they should return to the clinic; more research in this area is still needed, however.
If an in-person visit is requested or determined to be necessary, complete abortion should be confirmed clinically by bimanual pelvic examination. If serial measurements of human chorionic gonadotropin (hCG) in blood or urine are used, it should be remembered that in some cases low hCG levels can be detectable for up to four weeks after successful expulsion. Women may need to be referred for ultrasound scanning if there is reason to suspect ectopic pregnancy, failed abortion or complications. Women who continue to have symptoms of pregnancy and/or who have had only minimal bleeding are at high risk of still being pregnant.
Heavy or excessive bleeding
Vaginal bleeding occurs as part of the abortion process. For most women, vaginal bleeding starts between 1-2 hours after they take misoprostol. Bleeding is heavier than menstruation while abortion is occurring and the products of conception are being expelled. This heavy bleeding lasts only for a short duration, about 1-4 hours, and tapers off. Some women may experience a second episode of heavy bleeding a few weeks to many months after they have aborted ; this very rarely happens and cannot be predicted.
It should be noted that some women may present with bleeding after procuring and administering misoprostol on their own, without having seen a provider. This is particularly likely in settings where access to abortion is legally restricted. The clinician should evaluate whether abortion has already occurred and whether any further intervention is necessary.
On average, vaginal bleeding gradually diminishes over about two weeks after a medical abortion, but in individual cases spotting can last much longer. Generally, bleeding after medical abortion lasts longer than after vacuum aspiration. If the woman is well, neither prolonged spotting nor the presence of tissue in the uterus (as detected by ultrasound) is an indication for surgical intervention. Remaining products of conception will be expelled during the subsequent menstrual bleeding. Surgical evacuation of the uterus may be carried out at the woman’s request or if the bleeding is heavy or prolonged, or causes anemia, or if there is evidence of infection.
Genital infection should be excluded prior to initiating the medical abortion regimen. The genital tract is more susceptible to ascending infection when the cervix is dilated after abortion or childbirth. There are few data on the incidence of clinically significant systemic pelvic infection after medical abortion, but it seems to be rare and possibly occurs less often than after vacuum aspiration. Many of the symptoms of pelvic infection, such as pain, are rather nonspecific and hence precise diagnosis is difficult. Women with clinical signs such as pelvic pain, abdominal or adnexal tenderness, vaginal discharge and fever should be treated with broad-spectrum antibiotics .
Infection may be suspected if a woman:
When infection occurs with retention of products of conception, the woman needs to be given oral antibiotics and a surgical abortion should be performed. If infection is severe, then hospitalization and parenteral antibiotics may be required .
Eight deaths reported in the USA, one in Canada, and one in Portugal following medical abortion have been associated with infection from the anaerobic bacterium Clostridium sordellii ,  . The U.S. Centers for Disease Control and Prevention held a symposium in May 2006 and found no evidence that such deaths were linked to the drugs used for medical abortion. Twenty-one other cases of Clostridium infections have been identified in ob/gyn cases not associated with medical abortion in the USA, including thirteen cases of postpartum infection, four cases of spontaneous abortion, one case of surgical abortion, and three non-pregnancy cases. All but one of these infections was fatal. Research on Clostridium sordellii infections in the USA continues .
Prophylactic antibiotic treatment for all medical abortion patients is not mandatory. However, some clinics have incorporated this step into their protocols. In 2007, for example, Planned Parenthood of America clinics began mandating routine treatment with antibiotics for all of their medical abortions. They also switched misoprostol administration from vaginal to buccal .
If there is reason to suspect that pregnancy is ongoing when the woman returns for a follow-up visit at or within 14 days of taking abortion medication, a clinical examination, a hCG blood test (if the previous titre is available) or an ultrasound examination may be performed. The provider should always consider the possibility of an ectopic pregnancy.
If intrauterine pregnancy is ongoing, the provider may give the woman the option of further medical treatment (additional dose(s) of misoprostol appropriate to the gestation of the pregnancy), or a surgical abortion. If a woman wishes to continue with her pregnancy after a failed abortion, she should be informed of the risk of birth defects (see below) 
Health providers who are new to providing medical abortion may tend to intervene with surgical abortion much earlier than warranted. It is important to remember that about 10% of women may not begin to bleed within the first 24 hours following misoprostol. In most instances, waiting for a few more days and/or giving an additional dose of misoprostol may be adequate. Aspiration abortion may be needed only if evaluation shows pregnancy to be ongoing at the time of the follow-up visit. The decision to perform aspiration should not be based on ultrasound findings unless an ongoing pregnancy is identified.
Risk of fetal abnormality after a failed medical abortion
The following text is taken from Gynuity’s Providing Medical Abortion in Low-Resource Settings: An Introductory Guidebook (, p.6):
“A very small percentage of pregnancies may continue after administration of mifepristone-misoprostol. In such cases, if the woman then changes her mind about the abortion, or in the rare instance that the clinician fails to diagnose an ongoing pregnancy at a follow-up visit, the pregnancy may continue to term. Although it is possible that either drug could have teratogenic effects on the fetus, there is no evidence that mifepristone causes deformities. Limb defects and Möbius syndrome have been reported after misoprostol use but prospective data show no association with birth defects . Overall, data on misoprostol suggest a possible association between birth defects and in utero exposure to misoprostol at a narrow sensitive window very early in gestation. While the relative risk of malformations appears real, epidemiological studies indicated that the absolute risk is low (less than 10 malformations per 1,000 live births exposed to misoprostol in utero) , . During counseling, it is important to emphasize to the woman the need for follow-up and completion of the abortion if the pregnancy is ongoing. All women should be informed of the possibility of birth defects if they elect to continue a pregnancy to term after exposure to misoprostol.
Caution is needed when using misoprostol alone for pregnancies in the second trimester. The dosages of misoprostol must be reduced as the duration of pregnancy increases because, beyond 16 weeks, the uterus becomes very sensitive to prostaglandins. There is a risk of rupture of the uterus after 16 weeks of pregnancy and particularly in women who have a scar from a previous cesarean section . However, medical abortion can be used relatively safely, even in the second trimester, in women with a prior cesarean section , , , .
|3. Basic requirements in a health facility for providing medical abortion services|
In almost all countries where abortion is legal, there are regulations governing health facilities and personnel providing surgical abortion. These specify infrastructural facilities needed and personnel authorized to provide abortions, and usually require regular reporting by the health facility to the health authorities of the state/country. In many instances, these regulations may need to be updated to include appropriate requirements for medical abortion and, where needed, revise those for surgical abortion. Regulations would need to address the cadre of health-care professional who can provide medical abortion, training requirements and infrastructure, and resources needed for provision of medical abortion.
One of the major issues for which advocacy is needed is for approval by the national drug regulatory agency of mifepristone and misoprostol for medical abortion and other gynecologic and obstetric indications, and encouraging multiple pharmaceutical companies to register and distribute both products in the country at an accessible price. Since abortion is legally permitted for some indications in almost all countries, licensing and availability of mifepristone and misoprostol are needed so that women who have grounds for legal abortion can have access to the method.
Historically, only physicians have been authorized to provide abortions. Now that both aspiration and medical abortion procedures are greatly simplified, it is feasible to enable provision of both medical and aspiration abortion services by trained mid-level providers (such as nurses or nurse midwives), under the supervision of a physician. It is common medical practice for physicians to delegate the dispensing of medications to other health-care professionals under their supervision. Medical abortion can be safely provided by nurses and midwives. In France, Great Britain and Sweden, these mid-level providers are responsible for many aspects of the medical abortion process , including information provision and contraceptive counseling and provision. To date, in 10 states in the USA, regulations have been amended to allow nurse-midwives, nurse practitioners and physician assistants to be trained and they are now providing medical abortions in all those states .
In Sweden, midwives provide counseling on abortion methods and contraception, administer mifepristone and misoprostol and pain treatment as well as doing the follow-up after treatment , while in Great Britain, nurses may administer mifepristone and misoprostol but a physician has to prescribe them . In those parts of the USA, where only physicians may provide abortion services (including handing the medical abortion drugs to the client), telemedicine is being used to allow women in more remote locations access to medical abortion services even when a physician is not present. These women receive counseling and physical evaluations at their local clinic by non-physician clinicians; they then have a brief one-on-one video interaction with a physician located in another city. The physician controls (via computer) a locked drawer at the remote clinic and after the video evaluation the doctor releases the lock allowing each woman to access the necessary abortion medications .
Experiences of adapting and demedicalizing health technology and interventions for the management of malaria and tuberculosis, providing contraceptive services and treating obstetric emergencies show that non-physician, mid-level providers can play a significant role in making life-saving technology accessible even to those living in remote areas of developing countries. Studies in a growing number of countries, most recently a large study in Nepal, have shown that medical abortion can be safely provided by mid-level providers who may or may not be skilled in surgical evacuation procedures . Few complications occur and only rarely is an emergency referral to appropriate back-up facilities needed, including in developing country settings . In case of method failure, it is adequate if there is an assured referral link to a physician or a back-up facility.
All health providers responsible for providing medical abortion need to have training, including the following knowledge, skills and values :
It is important to note that a medical abortion provider need not be skilled in providing aspiration abortion.
Physicians who currently provide only surgical abortion should be assisted in adding medical abortion to their range of services. Preferably, they should be offered training in counselling and communication skills to make this an integral part of their interaction with patients. Alternatively, other staff in the health facility, mid-level providers as well as paramedics, may be trained to provide information and offer counseling to all women seeking abortion.
Medical abortion can be safely provided in primary health-care settings and other out-patient facilities, including private offices of practitioners, particularly when the protocol includes self-administration of the misoprostol by the woman in her home. For example, regulations in France have been modified to permit providers in licensed private facilities to do so ( www.fiapac.org).The space, however limited, should be so arranged as to ensure both visual and auditory privacy for the woman seeking abortion, during consultation with the health-care provider and during counseling.
Procedures need to be in place for ensuring patient confidentiality. Information disclosed to any staff person in the health-care setting should be protected and made available only to other staff directly involved in the patient’s care. Patient files should be stored in secure spaces not accessible to those not directly involved in patient care.
Basic amenities such as a working toilet and a comfortable waiting area with seats should be made available where possible. Adequate numbers of toilets and arrangements for provision and disposal of sanitary pads and disposal of the products of conception are especially important if misoprostol is being administered in the health facility.
Facilities for carrying out basic tests prior to administering the drugs are important. However, these tests can also be done off-site. Facilities are also needed for performing bimanual pelvic examinations – an examination table, sterile instruments, adequate privacy and a health provider competent to perform the examinations and interpret the findings.
During and after provision of medical abortion in the first trimester of pregnancy, it is sufficient if a mid-level provider or a physician is available for consultation in person or over the phone in case women have any concerns. With second-trimester abortion, a physician should be available throughout the process until expulsion of the products of conception has been confirmed.
Provision of medical abortion does not require emergency services on-site. For both first- and second-trimester medical abortion, good links with referral health facilities that can provide inpatient and/or emergency medical care for the small proportion of women who may need it are adequate. Modest inpatient facilities with facilities for overnight stay should be available if second-trimester medical abortion is to be provided.
At a minimum, the following should be available:
It is not essential for health facilities offering medical abortion to have ultrasound scanning equipment on the premises. Routine ultrasound scanning is not required for medical abortions.
Some health-care providers have expressed concerns that medical abortion will be a time-consuming procedure . However, most of the time involved is in giving the woman information, giving her the tablets and supporting the woman, much of which can be provided by auxiliary health staff.
The health facility providing medical abortion services should give women information on warning signs and symptoms of possible complications and what to do in case of a medical emergency.
Women may need to be referred for ultrasound scanning when there is doubt about duration of pregnancy or uncertainty regarding abortion success. There should be referral linkages with appropriate facilities where women can receive a surgical evacuation in case of method failure or emergency care. Existing emergency obstetric care facilities can play this role.
It is the responsibility of the public health system to ensure that all women seeking abortion within the national legal context and all women requiring post-abortion care have access to it, either through public health facilities, including the primary level as feasible, or through non-profit or other private clinical facilities (https://medicalabortionconsortium.com/articles/for-women-advocates-ngos/book3/?bl=en) .
1. Basic principles
Counseling is a communication process between a woman and a health-care provider that supports the woman to achieve her reproductive decisions. Each woman needs information on the medical and aspiration abortion procedures and, where possible, should be offered a choice between them and prepared for whichever procedure she opts. Most women have made up their own minds that they want an abortion; they do not need to “explore” their decision with the provider. It is usually very clear when a woman is unsure, e.g. whether or not to have an abortion or which abortion procedure to have, and then counseling can help the woman to reach her own decision. This situation is sometimes precipitated by the parents of young women, parents-in-law of young married women or by partners who seek to influence the woman’s decision one way or another. Counseling in this situation should be done in a non-directive way, with the aim of supporting the woman .
Counseling may also include discussing any topics relating to the woman’s (or couple’s) experiences and concerns, such as health-related fears, future plans, religious or spiritual values, and any misconceptions she/they may have about abortion or contraception. Good counseling always needs counselors to be sensitive to and involved with the situation and feelings of each woman. It requires flexibility, empathy and skills, which must constantly be strengthened.
Counseling and information provision do not always find a place of priority in abortion services. Barriers include:
All of these can be addressed if adequate investment is made in training and staffing, and if counseling is included in the standard protocol for provision of medical abortion services.
2. Content of information to provide on medical abortion
The following information is essential to provide and discuss with the woman during pre-abortion counseling:
Some points to be emphasized may be:
The woman then needs to decide which abortion method is best suited to her.
3. Informed consent
Ethical provision of abortion services, as with all medical care, requires obtaining formal informed consent from the woman requesting an abortion. Most informed consent forms ask the patient to affirm that she consents to undergo the procedure voluntarily after receiving full information about the procedure, eligibility criteria, and side-effects and complications.
An informed consent form should contain, as a minimum, the following details:
In clandestine settings, written consent forms may not be relevant or feasible. In these situations, consent should be obtained orally.
In settings hostile to the provision of abortion services there is a possibility that the informed consent procedure will be abused in order to try to put women off having an abortion. For example, abortion consent laws in some states of the USA include biased language, contain exaggerated or inaccurate statements about health risks, and impose cumbersome procedures, such as ultrasound examinations .
4. Information after mifepristone is given
After the woman receives mifepristone, she should be given the following information before she leaves the clinic:
During the first or second visit, women need to receive counseling on contraception (and supplies of the contraceptive method they choose to adopt), including the following details ,  :
For many women the period between the taking of the drugs and abortion completion is stressful. When successful termination of pregnancy is confirmed, there is a great sense of relief . Not all women need to return for an in-person follow-up visit, but some women may have new questions that need to be addressed, such as feelings related to the products of conception seen during expulsion. For women who do return for a follow-up appointment, questions should also be asked to ascertain whether the woman has started using contraception, and to encourage her to do so if she has not already done so. When appropriate, this topic can also be addressed at the initial visit thereby avoiding the need to return solely to discuss contraception. Those planning to use hormonal or barrier methods should be provided with adequate supplies and IUD insertion may be done after the abortion is complete for women who have opted for this method. Or an appointment can be given for a sterilization (or vasectomy for the woman’s partner).
For a small proportion of women whose abortion is incomplete or who are experiencing ongoing pregnancy, counseling support may be needed to prepare them for a further intervention. Women who opted for medical abortion because they were keen to avoid anesthesia or an invasive procedure may need particular support if their only option is a surgical intervention.
With a failed medical abortion, some women decide to continue the pregnancy to term. It is important to advise them of the risk of birth defects and the possibility of spontaneous miscarriage. Future follow-up with ultrasound examination to screen for fetal malformations should be considered.
The decision to have an abortion can be a difficult one. If women feel stigma and shame, they may be less likely to ask questions of the provider or to come for a follow-up visit. It is important to help them feel empowered by their decision and clear in their mind about the importance of motherhood being voluntary.
7. Self-administration of misoprostol at home
For women who will be self-administering misoprostol at home, the following information and counseling should be given:
During this stage the women may worry about bleeding and cramps. Support is important for women who will be self-administering misoprostol at home.
|5. Training for providing medical abortion|
The limited number of health-care providers trained to provide medical abortion is one of the most important bottle-necks to the availability of medical abortion.
Health professionals’ organizations and health-care providers with relevant authority can help to increase the number of trained providers of medical abortion by organizing observation and exposure visits for providers wishing to offer medical abortion and set up an effective medical abortion training program at their health facilities. It is also imperative to advocate for mid-level clinicians to be able to provide medical abortion in both public and private sectors.
Some issues to consider when planning for medical abortion training in a health facility include :
Training workshops on medical abortion can also be included as part of Continuing Medical Education (CME) programs. Teachers of undergraduate medical students, midwives and nurses are well placed to integrate basic information about medical abortion within the curriculum. They may also use a number of extra-curricular forums to expose students to information about abortion in general, and medical abortion in particular. Training workshops for medical students and all other health-care personnel (midwives, nurses) that go beyond clinical skills and seek to influence attitudes, address social and ethical issues related to abortion and improve communication and counseling skills are also important.
A range of resources for medical abortion training have been produced by the National Abortion Federation (USA), and are accessible online at: www.prochoice.org/education/resources/med_educational_resources.html
An excellent training curriculum is also available at: http://www.ansirh.org/training/workbook.php
|6. Promoting access to medical abortion in health systems|
1. Promoting access to safe abortion: the role of service providers
Advocacy may be defined as “the act or process of supporting a cause or issue” . Health professionals have played a pivotal role in many countries of the world in advocating for making abortion services safe and legal, and for expanding access to safe abortion services. They have also been at the forefront of promoting access to medical abortion in many countries, including developing countries such as China, India, Kenya, Nepal, Nigeria, South Africa, Tunisia, Turkey and Viet Nam. (https://medicalabortionconsortium.com/articles/for-women-advocates-ngos/book3/?bl=en )
Insert link to the section for NGOs, advocacy for health care providers, In Nigeria, the Campaign against Unwanted Pregnancy (CAUP) was initiated by a team of three medical doctors who were seeing many women die or suffer grievous health consequences from complications of unsafe abortions. Launched in 1991, over a period of 14 years CAUP has succeeded in placing unsafe abortion firmly on the political agenda and its members have carried out ground-breaking research on abortion in Nigeria and trained health providers in treating abortion complications. CAUP continues to advocate for changing the abortion law from a legally restrictive to a more liberal one .
Organizations such as Physicians for Reproductive Choice and Health (PRCH) and Medical Students for Choice in the USA and Doctors for a Woman’s Choice on Abortion in Great Britain are examples of initiatives by health-care providers to expand access to abortion through legal changes and advocacy within the profession.
This section draws on these experiences to present some examples of ways in which health-care providers and health-care managers can advocate for medical abortion, and/or contribute to the advocacy process through training and research.
Research evidence and its meticulous documentation represent powerful means of influencing policy-makers and fellow health-care providers. One of the ways health-care providers have influenced the approval, registration and introduction processes for medical abortion is to conduct national or local clinical and introductory trials.
Introductory trials take place after the safety and effectiveness of a new method has been established through initial clinical trials. Clinical studies and introductory trials carried out in India, Viet Nam, Tunisia, and Moldova, for example, were instrumental in gaining support for the national introduction of medical abortion for pregnancy termination. Introductory trials may examine safety and effectiveness in the national or local setting, but usually focus more on the acceptability of medical abortion and on service delivery requirements. An introductory trial in Turkey, for example, found that 75% of women who chose medical abortion opted for home use of misoprostol and 90% of women who had medical abortion said they would prefer it again if they had to have another abortion. Such findings supported the introduction of early medical abortion in Turkey .
Not only professional researchers but all health-care providers can have a role in adding to the body of knowledge on medical abortion services. They can do so by carrying out service delivery research based on data from clinic logbooks, observation of counseling sessions, interviews with women and providers, feedback forms and staff discussions.
|7. Medical abortion in legally restricted settings|
Women seeking an abortion in a setting where abortion is legally restricted may be left very much on their own through all or part of the abortion process, no matter what abortion method is used and no matter what sort of provider they have seen, if any. Mifepristone is very unlikely to be available in such settings, and misoprostol will therefore be used alone unless the provider can prescribe methotrexate.
It is important that pharmacists, midwives, nurses and clinicians are aware of how misoprostol alone can be used as safely and effectively as possible. When women are self-administering medical abortion, clinicians may have concerns about women taking control of their own health care. This can result in an unwillingness to share information about correct dosages. However, this is a mistake. Using a harm reduction model, they should advise and help women to avoid unsafe outcomes.(https://medicalabortionconsortium.com/articles/for-women-advocates-ngos/book3/?bl=en )
Most of the clinicians and other providers doing abortions unofficially will be private providers, or public providers working in private settings. Providers also need to protect their own professional positions and may or may not be able to see women through the whole process. Resources for follow-up care may also be limited to a greater or lesser extent because of the legal environment.
Unsafe abortion is a public health disgrace that can only be resolved through making abortion legal and safe.
|8. Annex 1. Sample patient information leaflet|
Today, ______________________ you have taken a pill called mifepristone to end your pregnancy. You took 200 milligrams of mifepristone at _______ am/pm. You will probably not feel different after taking this pill. You may have some vaginal bleeding as well as some nausea and/or vomiting.
a) FOR THOSE SELF-ADMINISTERING MISOPROSTOL AT HOME
Anytime between 24 to 48 hours from now, between ______ am/pm on ____(date) and _____ am/pm on ______(date), you must put 4 pills of another medicine, misoprostol, under your tongue. You must do this even if you have already started to bleed. Each misoprostol pill is 200 micrograms. Choose a time when you have had a good meal and plenty of rest.
You should hold the pills under your tongue for 20-30 minutes and then swallow any remaining fragments.
b) FOR THOSE RETURNING TO THE CLINIC FOR MISOPROSTOL
You are to return to the clinic 24 to 48 hours from now, between ____am/pm on ______(date) and ______am/pm on _____ (date). At that time, misoprostol will be inserted vaginally by the health care worker. You will also receive a date for your final follow-up visit at this time.
Drink plenty of fluids (avoid alcohol), and eat lightly.
Monitor your bleeding.
You may experience nausea and/or vomiting, diarrhea, fever, and/or chills. These are normal side-effects and usually pass within a few hours after taking the misoprostol. If a fever lasts for more than four hours or develops more than a day after you take the misoprostol, you should contact the clinic right away.
When to call for help
Call the emergency number we have given you before going to another physician's office or emergency room. When you call be prepared to give the following information:
Most women (95-98%) will have a complete abortion. If your pregnancy has continued to grow (about 1% of treated women), we recommend that you have a suction procedure to end the pregnancy because of the possible risk of birth defects. You are, however, free to continue with the pregnancy, if you so wish. If your pregnancy has not continued, but has not passed from your uterus (less than 5% of women), you may either:
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