A research consortium that includes researchers, advocates, and accompaniment providers collaboratively designed this study to ensure that it reflected the priorities, experiences, and preferences of people who self-manage abortions with medication. Study investigators invited individual consortium members (included as co-authors) to participate based on their expertise in self-managed medication abortion and accompaniment models in a range of legal and cultural settings, to ensure the design of a study that reflected the lived experiences of people who self-manage, the accompaniers who support them, and contexts similar to those in which the study will take place. The overall study protocol was reviewed and approved by the Allendale Investigational Review Board, by a local IRB as appropriate, and by a study-specific Data Monitoring and Oversight Committee (DMOC) with medication abortion experts from each study country, and a chair with research expertise in clinical medication abortion effectiveness studies.
Data for this study were collected in three countries located in South America, Southeast Asia, and West Africa. The names of the abortion accompaniment groups and their home countries are blinded due to safety and legal concerns for those managing the hotlines, and the hotline callers. The three included accompaniment groups were selected to represent variation in legal and sociocultural contexts with respect to abortion, and because they each had identified research as an important mechanism for informing policy and practice. The three accompaniment groups vary somewhat in their approach, but each involves an initial screening conversation with the pregnant person that takes place via secure messaging or a telephone call. During this screening conversation, the accompaniment counselor confirms that the person is seeking abortion for themselves, that the person is not being coerced, and that they have no known contraindications to medication abortion. Further, the counselor assesses the gestational age of the pregnancy based on either the date of last menstrual period as reported by the caller, or an independently acquired ultrasound. For callers who obtained an ultrasound, gestational age is based on the ultrasound dating. After confirming eligibility for medication abortion, the counselors then provide step-by-step instructions for how to use medication to induce abortion based on current WHO protocols (Appendix 1; of note, some of these regimens include off-label use of mifepristone and misoprostol), information on obtaining the medications, and highly detailed guidance on assessing abortion completion and potential warning signs of complications, as well as when formal healthcare may be needed. Accompaniment group staff are in frequent contact with callers during the medication abortion process to answer questions and provide support to the person self-managing an abortion. The accompaniment group in South America provides information primarily on a combined mifepristone and misoprostol regimen, while the groups in Southeast Asia and West Africa counsel on both a combined and misoprostol alone regimen, depending on which pills the caller is able to obtain.
Study design and data collection
This pilot study was a prospective, observational study in which people who contacted an accompaniment group for information and support with self-managing a medication abortion were enrolled and followed for up to six weeks to assess their abortion outcome and experiences. As one of the primary aims of the pilot study was to assess feasibility, sample size was flexibly set to the number of people counselors could successfully recruit in 30 days. Pilot study enrollment at each site was open for approximately 30 days in April and May of 2019. Participants were followed up to six weeks, with most followed for three-weeks. We conducted the last follow-up interview in June 2019. Survey instruments were professionally translated into local languages as needed for each site, and were then pre-tested with four to five cognitive interviews in each country (13 total), and then updated accordingly.
During the initial counseling conversation, accompaniment counselors assessed all callers to the accompaniment group for eligibility for study participation during the 30 days. Eligibility criteria included: (1) having contacted the accompaniment group seeking information about induced abortion for their own pregnancy; (2) being at least 13 years of age; (3) being able to give informed consent; (4) being able to speak a local language; (5) meeting hotline eligibility criteria for starting the medication abortion process (i.e. no contraindications to medication abortion; Appendix 1); and (6) starting a new medication abortion process. Callers were excluded from the study if they (1) had taken medications in an attempt to end the current pregnancy within the 30 days prior to contacting the hotline; (2) were experiencing ongoing symptoms of spontaneous or induced abortion (bleeding, cramping) at the time of contacting the hotline; (3) had a known ectopic pregnancy; (4) did not want to share their contact information with study staff; (5) did not want to be contacted again by the hotline or by study staff; or (6) were not willing to comply with study procedures. Callers of any gestational age were eligible to participate in the study. Eligible participants were invited to participate by the accompaniment counselor at the end of the first counseling conversation. Participants who expressed interest proceeded through an informed consent conversation with detailed information about study participation, risks and benefits. All participants who gave their informed consent to participate were enrolled into the pilot study.
Immediately after enrollment, each participant answered baseline questions about their current pregnancy, reproductive history, contact information, and select sociodemographic characteristics. Follow-up surveys were completed by trained study coordinators at each site, recruited from trusted partner organizations, and employed full time on the research study for the duration of recruitment and data collection at each site. The first follow-up survey was conducted over the phone (voice-call or secure messaging) one-week after the pills were scheduled to be taken. This one-week follow-up inquired about obtaining the medications, medication type, detailed information on timing and route of administration, pain, bleeding and cramping during the abortion, and self-reported assessment of abortion completion. Two weeks after the first follow-up, approximately three-weeks after the medication was taken, study coordinators contacted participants for a second-follow-up that included questions about any additional doses taken, warning signs of complications, completion of abortion, healthcare seeking, disclosure of the abortion, satisfaction with the accompaniment group, and emotions about the experience. Participants who reported they were no longer planning to take the pills, were asked why, and no further follow-up was conducted. Participants received an incentive in the form of phone credit for each survey completed. Study coordinators entered all survey data into a secure, online platform.
Effectiveness of self-managed medication abortion. The primary outcome of interest was effectiveness of self-managed medication abortion with accompaniment group support, defined as complete abortion at last study contact, without surgical intervention at any point. We classified an abortion process as “effective” if the participant responded “yes” to the question, “Do you feel that your abortion process is complete?” and did not report a surgical intervention when asked “At the health facility, what treatment did you receive?” (among participants who reported seeking medical care at a health facility during or after their abortion process). Participants also reported why they felt their abortion was complete, and if they had an ultrasound, or had taken a pregnancy test to confirm completion. We also calculated a secondary, more inclusive definition of “effective”– defined as a participant who was no longer pregnant at the end of follow-up, regardless of whether surgical intervention took place or not.
Complications. Warning signs of potential complications of self-managed medication abortion were assessed by asking participants to self-report any occurrence of (1) heavy bleeding that soaked more than two pads per hour for more than two hours, (2) pain that did not go away with the use of painkillers, (3) fever that lasted for over 24 hours, and (4) foul smelling vaginal discharge. Participants were also asked about whether they experienced side effects at any point in the abortion process, including fever, diarrhea, nausea, vomiting, or dizziness, as well as signs of potential allergic reaction, including itchiness, difficulty breathing, sweaty hands, or face numbness.
Complications were identified based on participant self-report and receipt of treatment. Those who sought care at a facility at any point in the process were asked why they sought care and what treatment they received (surgical intervention, antibiotics, other medications, or observation).
We summarized baseline sociodemographic characteristics and data on reproductive history for the study population through measures of frequency and central tendency. We then calculated the proportion of participants who successfully obtained medications for abortion and used the medications to self-manage abortion at the one-week follow-up, and described the medication abortion experience stratified by type of medication regimen. Finally, we calculated the proportion of participants who completed the abortion, the proportion who sought care, and the proportion that reported warning signs of complications by the three-week follow-up. We conducted all analyses in Stata version 15.0. We double-entered study data for 46 participants (20%) to check for any systematic errors in data entry. We then conducted a sensitivity analysis to re-estimate the primary outcome under the conservative assumption that all those lost to follow-up had incomplete abortions.