Same-day Long-acting Reversible Contraception for Medication Abortion (SaLMA)

April 6, 2017 updated by: Boston University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

  • Desiring and eligible for medication abortion
  • Desiring and eligible for etonogestrel implant or DMPA

Exclusion Criteria:

  • Contraindications to DMPA or etonogestrel implant per CDC guidelines regarding United States Medical Eligibility for Contraceptive Use (Centers for Disease Control, 2010)
  • Contraindications to mifepristone and misoprostol including ectopic pregnancy, pregnancy with intrauterine device in place, chronic adrenal failure, significant anemia, bleeding disorder, chronic steroid use, inability to follow up, lack of emergency medical access, allergy to mifepristone or misoprostol, malignant liver tumor, benign hepatocellular adenoma, systemic lupus erythematosis with antiphospholipid antibody syndrome, active liver disease, or history of breast cancer or current breast cancer
  • Nonworking telephone number (as assessed on initial visit)
  • Unable to give informed consent, or unable to speak English, Spanish, or French Creole
  • Unable to be contacted because of confidentiality issues
  • Currently breastfeeding
  • Intending to move away from the Boston area within one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DMPA
DMPA given at the time of mifepristone for medical abortion
Drug: DMPA
DMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion
Other Names:
  • Depo Provera
Etonogestrel implant
Etonogestrel implant placed at the time of mifepristone for medical abortion
Drug: Etonogestrel implant
Etonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion
Other Names:
  • Implanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with timing of contraceptive administration
Time Frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
7 days, 14 days, 28 days, 3, 6, 9, 12 months
Continuation rate of contraceptive method
Time Frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
7 days, 14 days, 28 days, 3, 6, 9, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of days of bleeding
Time Frame: 28 days
28 days
Follow-up rate after abortion
Time Frame: 14 days
14 days
Failure of medical abortion
Time Frame: 7 days
7 days
Reasons for non-enrollment
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Family Planning Fellowship

Investigators

  • Principal Investigator: Sarita Sonalkar, MD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-30255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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