Abortion; Induced Clinical Trial
Official title:
Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion
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.
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.
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