Same-day Long-acting Reversible Contraception for Medication Abortion
Condition: Abortion; Induced
Study type: Observational

Summary: 
      Contraception after abortion is an important public health issue, as women who have an
      abortion are at high risk for additional unintended pregnancy. In the context of first
      trimester medical abortion, the standard of care is to administer long-acting reversible
      contraception, including the etonogestrel implant (Implanon) and depot medroxyprogesterone
      acetate (DMPA), at a follow-up appointment after the abortion.

      The investigators plan to conduct a prospective observational pilot study to evaluate the
      satisfaction of subjects who have selected either the contraceptive implant or DMPA given on
      the first day of medical abortion, as opposed to at a follow-up appointment. The
      investigators will also assess the continuation of DMPA and Implanon at 3, 6, 9, and 12
      months after the initial date of administration. In addition, the investigators will assess
      the total days of bleeding after the abortion, follow-up rate for evaluation of completion of
      medical abortion, and efficacy of medical abortion.

      A total of 40 participants will be recruited, 20 who choose Implanon and 20 who choose DMPA.
      They will be asked to fill out questionnaires during the course of the study, and will be
      followed for one year. The study duration including data analysis will be two years.
    

Detailed description: 
      This is a prospective, observational pilot study of administration of either Implanon or DMPA
      on the first day of medication abortion. Subjects in this two cohorts will be followed for
      one year, with questionnaires administered at intake, 2 weeks, 4 weeks, and 3, 6, 9, and 12
      months after recruitment.

      On the day of recruitment, after the patient has consented both to medication abortion and
      contraceptive method (Implanon or DMPA), the provider will ask the patient if they are
      interested in participation in the study. If the patient is interested, a research assistant
      or investigator will be called to discuss the study in private with the potential subject.
      Consent will be obtained by the investigator, and the intake questionnaire with baseline
      contraceptive and demographic data will be administered. Mifepristone for medication abortion
      will be administered per protocol by the provider, and then Implanon or DMPA will be
      administered. The clinician who provides the medication abortion will not be the same person
      as the investigator who is consenting for research. A bleeding diary card will be given to
      the subject to record daily bleeding. The subject will be requested to return this card by
      mail in 4 weeks, and will be given an addressed and stamped envelope.

      Subjects will be scheduled for a 7-day follow-up appointment as per medication abortion
      protocol, and at that visit, a short questionnaire regarding the satisfaction with timing of
      contraceptive method, and number of days of bleeding will be administered. Subjects will then
      be contacted by their preferred modality (phone, email, or text message) at 2 weeks, to
      assess for total days of bleeding. If the subject is continuing to have bleeding, they will
      be contacted again at 4 weeks to assess for total days of bleeding. At each of these contact
      points, satisfaction with timing of placement, and satisfaction with contraceptive method
      will be assessed via a Likert scale. Additional contact will be made at 3, 6, 9, and 12
      months for all subjects to assess continuation of the contraceptive method.

      If unable to contact the subject or listed emergency contacts a total of five times by their
      preferred or alternate modalities of contact, a letter will be sent along with a
      self-addressed stamped envelope.

      Outcomes (Indicate anticipated primary and any secondary outcomes and how they will be
      measured):

      The primary study objectives are to assess the following:

        1. Subject satisfaction with timing of placement as determined by questionnaire

        2. Continuation of contraceptive method at 3, 6, 9, and 12 month as determined by
           questionnaire

      The secondary study objectives are to assess the following:

        1. Total days of bleeding after the abortion

        2. Follow-up rate for evaluation of completion of medication abortion

        3. Failure rate of medication abortion

        4. The number of women screened for participation

        5. Reasons for refusal to participate in the study

        6. Reasons for ineligibility

        7. The number of women who change their contraceptive method during the year of follow-up.
    

Intervention name(s): DMPA; Etonogestrel implant
Intervention type(s): Drug; Drug
Intervention description(s): DMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion; Etonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion
Other intervention name(s): Depo Provera; Implanon
Intervention MeSH terms: Medroxyprogesterone Acetate; Etonogestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be women who elect a medication abortion at Boston Medical Center
        and who desire either Implanon or DMPA. Those that appear to meet the eligibility and none
        of the exclusion criteria will be asked by their clinician if they are interested in
        participating in the observational study. Those interested will be contacted by the PI or
        PI's designated staff to discuss details about the study.
      
Keywords: long acting reversible contraception; medical abortion; DMPA; etonogestrel implant; Implanon; contraceptive continuation