Chapter 3. Recommendations and best practice statements across the continuum of abortion care

Medical management of induced abortion: Recommendations 27-30 (3.4.2)

3.4.2 Medical management of induced abortion

Medical management of spontaneous and induced abortion (for both viable and non-viable pregnancies) at early or later gestational ages involves the use of a single-dose regimen or a combination regimen of medicines used in sequence, with specific dosages and routes of administration.

The medicines that have been used for some decades for medical abortion are mifepristone in combination with misoprostol, or misoprostol alone. Similar to mifepristone, letrozole can be used in combination with misoprostol for medical abortion at early gestational ages. Letrozole is a third-generation selective aromatase inhibitor. Its mechanism of action involves suppression of estrogen levels, which modifies the progesterone receptor concentration, subsequently leading to pregnancy loss.

Medical abortion is a process that takes place over a period of up to several days rather than being a discrete procedure. In addition to information provision (including reasons to seek urgent care at any point during the process), medical abortion includes the following components or subtasks:

  1. assessing eligibility for medical abortion (diagnosing and dating the pregnancy, ruling out medical contraindications);
  2. administering the abortion medicines with instructions on their appropriate use and managing the common side-effects;
  3. assessing whether the abortion process has had a successful outcome and whether any further intervention is required.

One health worker can provide the whole package of care for medical abortion, but it is equally possible for the subtasks to be carried out by different health workers and at different locations, including remotely. In addition, given the nature of the medical abortion process, it is also possible for women to manage the process by themselves outside of a health-care facility (e.g. at home), with support if and when needed. Such self-assessment and self-management approaches can be empowering for women and help to triage care, leading to a more woman-centred and more optimal use of health resources.

Routes of administration for misoprostol used for medical abortion:

  • Oral – pills are swallowed immediately
  • Buccal – pills are placed between the cheek and gums and swallowed after 20 to 30 minutes
  • Sublingual – pills are placed under the tongue and swallowed after 30 minutes
  • Vaginal – pills are placed in the vagina

CLINICAL SERVICES Recommendation 27: Medical management of induced abortion at gestational ages < 12 weeks

For medical abortion at < 12 weeks:

  1. Recommend the use of 200 mg mifepristone administered orally, followed 1–2 days later by 800 μg misoprostol administered vaginally, sublingually or buccally. The minimum recommended interval between use of mifepristone and misoprostol is 24 hours.*
  2. When using misoprostol alone: Recommend the use of 800 μg misoprostol administered buccally, sublingually or vaginally.*
  3. (NEW) Suggest the use of a combination regimen of letrozole plus misoprostol (letrozole 10 mg orally each day for 3 days followed by misoprostol 800 μg sublingually on the fourth day) as a safe and effective option.*ǂ

Remarks:

  • Evidence from clinical studies demonstrates that the combination regimen (Recommendation 27a) is more effective than misoprostol alone.
  • All routes are included as options for misoprostol administration, in consideration of patient and provider preference.
  • The suggested combination regimen of letrozole plus misoprostol may be safe and effective up to 14 weeks of gestation.

* Repeat doses of misoprostol can be considered when needed to achieve success of the abortion process. In this guideline we do not provide a maximum number of doses of misoprostol.

ǂ Further evidence is needed to determine the safety, effectiveness and acceptability of the letrozole plus misoprostol combination regimen at later gestational ages, especially in comparison with that of the mifepristone plus misoprostol combination regimen (the available evidence focused on comparison with the use of misoprostol alone).

Source: Recommendations 27a and 27b carried forward from WHO (2018) where they were Recommendation 3a (120). Recommendation 27c is new.

SERVICE DELIVERY Recommendation 28: Medical management of induced abortion at gestational ages < 12 weeks,* in whole or in part (i.e. performing all or some of the subtasks; see list at start of section 3.4.2) using mifepristone plus misoprostol, or misoprostol aloneǂ

Recommendation Rationalea
Type of health worker
Community health workers (CHWs) Recommend Evidence was found for the safety, effectiveness and acceptability of this option, for all three subtasks of medical abortion (moderate certainty). The skills and knowledge for this task (according to the competency framework) align with the competencies for this type of health worker.a Indirect evidence also demonstrated the feasibility and acceptability of CHWs facilitating assessment of eligibility and outcome.
Pharmacy workers Recommend Limited evidence was found for the safety, effectiveness, acceptability or feasibility of this option (non-comparative studies). The skills and knowledge for this task (according to the competency framework) align with the competencies for this type of health worker.a Indirect evidence on CHWs was applied to support the feasibility of this option.
Pharmacists Recommend Although insufficient evidence was found for the safety, effectiveness and acceptability of pharmacists performing the three subtasks of medical abortion, the skills and knowledge for this task (according to the competency framework) align with the competencies for this type of health worker.a Dispensing medicines on prescription is within their typical scope of practice. The expert panel affirmed that, with the aid of tools for assessment of eligibility and outcome, it would be feasible for pharmacists to provide all three subtasks of medical abortion.
Traditional and complementary medicine professionals Recommend Evidence was found for the safety and effectiveness of this option, and for women’s satisfaction with this type of provider and services provided by them (very low certainty). The skills and knowledge for this task (according to the competency framework) align with the competencies for this type of health worker.a The expert panel affirmed that the benefits outweigh any possible harms, and the potential to increase equitable access to quality abortion care in regions where these professionals constitute a significant proportion of the health workforce is high.
Auxiliary nurses/ANMs Recommend Evidence was found for the safety and effectiveness of this option (moderate certainty). This option is feasible and is already being implemented in some low-resource settings.
Nurses Recommend Evidence was found for the safety and effectiveness of this option, and for women’s satisfaction with abortion services with this option (moderate certainty).
Midwives Recommend Evidence was found for the safety and effectiveness of this option (moderate certainty). More women are satisfied with the provider when midwives provide medical abortion (moderate-certainty evidence). This option is feasible and is already being implemented in several countries.
Associate/advanced associate clinicians Recommend Insufficient direct evidence was found for the effectiveness of these clinicians carrying out components of the task, e.g. assessing gestational age as part of provision of manual vacuum aspiration. Evidence was also found that health worker types with similar or less comprehensive basic training (e.g. midwives, nurses, auxiliary nurse midwives) can provide medical abortion safely and effectively (moderate certainty). This option is feasible and the potential to expand access to underserved populations is high.
Generalist medical practitioners

Specialist medical practitioners

Recommend Within their typical scope of practice,b therefore no assessment of the evidence was conducted.
Individual/self    
Pregnant woman, girl or other pregnant person Recommend Please refer to Recommendation 50 in section 3.6.2 for rationale, remarks and implementation considerations for this recommendation and further information on self-management approaches.
Source: Recommendation updated from WHO (2015) (23).

Note on updating of the recommendation: This was an existing recommendation for which evidence relating to traditional and complementary medicine professionals (previously only recommended in contexts with established health system mechanisms for the participation of these health workers in other tasks related to maternal and reproductive health), pharmacists (previously only suggested in the context of rigorous research), pharmacy workers (previously “recommend against”), community health workers (previously only suggested in the context of rigorous research) and individual/self (self-management; previously “suggest”) was reviewed using GRADE methodology. After review, the recommendations were upgraded for all of those health worker categories to “recommend”, including all three subtasks of this intervention. A summary of the evidence is presented in Supplementary material 3, EtD framework for Medical abortion at < 12 weeks.

a For this and all health worker recommendations, given the limited evidence for many of the health worker–task combinations, the discussions of the expert panel focused on the competency framework in WHO’s 2011 publication, Sexual and reproductive health: core competencies in primary care (121), which provides information on the competencies (including skills and knowledge) required for each task, and also the WHO-INTEGRATE criteria, in particular on the feasibility, equity and acceptability of the intervention and women’s values and preferences.

b For typical scope of work/practice, please refer to Annex 5: Health worker categories and roles.

* Available evidence for the independent provision of medical abortion by non-physicians is for pregnancy durations up to 10 weeks (70 days).

ǂ For this recommendation, the medical abortion regimens covered in the available evidence were mifepristone plus misoprostol, or misoprostol alone (the regimen using letrozole was not included).

No requirement for location (on-site vs off-site).

Implementation considerations
  • It is not essential that the person providing the medical abortion should also be trained and competent in vacuum aspiration provision.
  • Restrictions on prescribing and dispensing authority for some categories of health workers may need to be modified within the regulatory framework of the health system or other mechanisms put in place to allow these providers to make the medicines available to abortion seekers.
  • Privacy should be ensured in all settings, in particular in places where a private space may be challenging (e.g. pharmacies).
  • Support tools can be used to assess eligibility and outcome (e.g. high-sensitivity pregnancy tests, checklists).
  • A range of service-delivery models exist to facilitate the medical abortion process, such as telemedicine or community outreach (see section 3.6.1).
  • Mechanisms to ensure access to quality medicines need to be set up. Development of tools like point-of-care tests to assess quality could support both the pharmacy worker and the individual.
  • It is important to note that as with all other medicines, pharmacy workers should dispense mifepristone and misoprostol as indicated by prescription.
  • The person undergoing medical abortion should have access/referral to emergency care in case this becomes necessary.
  • As part of the enabling environment, health workers should recognize self-management as a legitimate pathway to abortion care and to adapt health systems to facilitate and support women in their self-management of abortion, e.g. adapting clinical protocols.
  • Mechanisms need to be established to ensure access or referrals to post-abortion contraception services and provision of contraceptives for women who want them.
Rationale for Recommendation 27c (combination regimen of letrozole plus misoprostol)

A systematic review assessed the efficacy, safety and acceptability of alternative methods of medical abortion to the standard regimens using mifepristone and/or misoprostol. The literature search identified seven studies, all of which reported on the combination of letrozole plus misoprostol (intervention) versus misoprostol alone (comparison) for medical abortion. No studies were identified that compared letrozole plus misoprostol versus mifepristone plus misoprostol. The study settings included China, Egypt and Islamic Republic of Iran. A summary of the evidence is presented in Supplementary material 2, EtD framework for New medical methods for abortion.

Overall, the evidence favoured the intervention. The use of letrozole in combination with misoprostol showed lower rates of ongoing pregnancy and higher rates of successful abortion, based on low- to very low-certainty evidence. In addition, fewer women experienced side-effects, based on moderate-certainty evidence.

Discussion on the cost-effectiveness, equity, feasibility and acceptability favoured the intervention. Letrozole’s typical use for infertility and cancer treatment makes it more readily accessible than mifepristone in certain parts of the world. In addition, the low cost of letrozole is another contributing factor to making this an alternative method for medical abortion.

CLINICAL SERVICES Recommendation 29: Medical management of induced abortion at gestational ages ≥ 12 weeks

For medical abortion at ≥ 12 weeks:

  1. Suggest the use of 200 mg mifepristone administered orally, followed 1–2 days later by repeat doses of 400 μg misoprostol administered buccally, sublingually or vaginally every 3 hours.* The minimum recommended interval between use of mifepristone and misoprostol is 24 hours.
  2. When using misoprostol alone: Suggest the use of repeat doses of 400 μg misoprostol administered vaginally, sublingually or buccally every 3 hours.*

Remarks:

  • The combination regimen (Recommendation 29a) is more effective than use of misoprostol alone.
  • Evidence suggests that the vaginal route is the most effective. Consideration for patient and provider preference suggests the inclusion of all routes.
  • Pregnancy tissue should be treated in the same way as other biological material unless the individual expresses a desire for it to be managed otherwise.

* Misoprostol can be repeated at the noted interval as needed to achieve success of the abortion process. Providers should use caution and clinical judgement to decide the maximum number of doses of misoprostol in pregnant individuals with a prior uterine incision. Uterine rupture is a rare complication; clinical judgement and health system preparedness for emergency management of uterine rupture must be considered with later gestational age.Source: Recommendation 3b carried forward from WHO (2018) (120).

SERVICE DELIVERY Recommendation 30: Medical management of induced abortion at gestational ages ≥ 12 weeks

Type of health worker Recommendation Rationalea
Traditional and complementary medicine professionals Suggest

Condition: In contexts where established and easy access to appropriate surgical backup and proper infrastructure is available to address incomplete abortion or other complications.

Although no direct evidence was found on the safety, effectiveness or acceptability of this option, the skills and knowledge for this task (according to the competency framework) align with the competencies for this type of health worker.a In addition, these professionals have been recommended to provide medical abortion at < 12 weeks (Recommendation 28). The potential to increase equitable access to quality abortion care in regions where these professionals form a significant proportion of the health workforce is high.
Auxiliary nurses/ANMs Suggest

Condition: In contexts where established and easy access to appropriate surgical backup and proper infrastructure is available to address incomplete abortion or other complications.

Although no direct evidence was found on the safety, effectiveness or acceptability of this option, the skills and knowledge for this task (according to the competency framework) align with the competencies for this type of health worker.a In addition, these health workers have been recommended to provide medical abortion at < 12 weeks (Recommendation 28). This option is feasible and acceptable and has the potential to increase equitable access to quality abortion care.
Nurses Suggest

Condition: In contexts where established and easy access to appropriate surgical backup and proper infrastructure is available to address incomplete abortion or other complications.

Although insufficient direct evidence was found for the safely and effectiveness of nurses providing this intervention as a whole, these health workers are often responsible for the monitoring and care of women from the time of misoprostol administration to completion of the abortion. Women often find abortion care provided by nurses to be more acceptable (moderate-certainty evidence).
Midwives Suggest

Condition: In contexts where established and easy access to appropriate surgical backup and proper infrastructure is available to address incomplete abortion or other complications.

Although insufficient direct evidence was found for the safety and effectiveness of midwives providing this intervention as a whole, these health workers are often responsible for the monitoring and care of women from the time of misoprostol administration to completion of the abortion. Women often find abortion care provided by midwives to be more acceptable (moderate-certainty evidence).
Associate/advanced associate clinicians Suggest

Condition: In contexts where established and easy access to appropriate surgical backup and proper infrastructure is available to address incomplete abortion or other complications.

Although insufficient direct evidence was found for the safety of effectiveness of this option, these clinicians routinely carry out tasks of similar complexity (e.g. vacuum aspiration and manual removal of placenta) (138). These clinicians are often present at higher-level facilities where care during advanced gestation is provided. A trained specialist medical practitioner may not always be present at higher-level facilities and the potential to sustain services for advanced gestational ages is increased with more than one trained provider on site.
Generalist medical practitioners Recommend Although insufficient direct evidence was found for the safety and effectiveness of this option, generalist medical practitioners routinely carry out tasks of similar or greater complexity (e.g. conducting deliveries, manual removal of placenta, vacuum aspiration). The potential benefits of this option outweigh the harms and the intervention has proven feasible in several settings. A specialist medical practitioner may not always be available on-site and therefore this option may increase equitable access to quality abortion care.
Specialist medical practitioners Recommend Within their typical scope of practice,b therefore no assessment of the evidence was conducted.
Source: Recommendation updated from WHO (2015) (23).

Notes on updating of the recommendation: This was an existing recommendation for which evidence relating to all health worker categories was reviewed using GRADE methodology, except for specialist and generalist medical practitioners, for whom there was already a strong recommendation for this task. After review, the recommendations were upgraded for traditional and complementary medicine professionals and auxiliary nurses/ANMs from “recommend against” to “suggest” with specified conditions. For the other health worker categories reviewed, the recommendations remain unchanged. A summary of the evidence is presented in Supplementary material 3, EtD framework for Medical abortion at ≥ 12 weeks.

a For this and all health worker recommendations, given the limited evidence for many of the health worker–task combinations, the discussions of the expert panel focused on the competency framework in WHO’s 2011 publication, Sexual and reproductive health: core competencies in primary care (121), which provides information on the competencies (including skills and knowledge) required for each task, and also the WHO-INTEGRATE criteria, in particular on the feasibility, equity and acceptability of the intervention and women’s values and preferences.

b For typical scope of work/practice, please refer to Annex 5: Health worker categories and roles.

Medical abortion for pregnancies at gestational ages ≥ 12 weeks has been practised and researched as a facility-based procedure during which women should remain under observation until the process is complete.

Implementation consideration
  • Health workers providing abortion or caring for women undergoing abortion at gestational ages ≥ 12 weeks may have additional needs for professional and mentoring support.

KEY HUMAN RIGHTS CONSIDERATIONS RELEVANT TO MEDICAL ABORTION

  • Everyone has a right to privacy and confidentiality in sexual and reproductive health (SRH) care.
  • Abortion regulation should be human rights and evidence based.
  • States must ensure adequate access to essential medicines in an affordable and non-discriminatory manner.
  • Everyone has the right to scientific progress and right to health, which requires the availability and accessibility, acceptability, and quality of medical abortion. This means that States should ensure access to abortion medicines, and that evidence-based standards and guidelines for the provision and delivery of SRH services, are (i) in place and (ii) routinely updated to incorporate medical advancements.

For further information and sources, please refer to Box 1.2 and Web annex A: Key international human rights standards on abortion.