This trial is active, not recruiting.

Condition medical abortion, complete or unspecified, without complication
Treatments dmpa, etonogestrel implant
Phase phase 2/phase 3
Sponsor Boston University
Collaborator Family Planning Fellowship
Start date May 2011
End date April 2014
Trial size 40 participants
Trial identifier NCT01356927, H-30255


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 pilot study to evaluate the satisfaction of subjects who have 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
DMPA given at the time of mifepristone for medical abortion
dmpa Depo Provera
DMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion
Etonogestrel implant placed at the time of mifepristone for medical abortion
etonogestrel implant Implanon
Etonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion

Primary Outcomes

Satisfaction with timing of contraceptive administration
time frame: 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

Secondary Outcomes

Number of days of bleeding
time frame: 28 days
Follow-up rate after abortion
time frame: 14 days
Failure of medical abortion
time frame: 7 days
Reasons for non-enrollment
time frame: 1 year

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion
Principal investigator Principal Investigator
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Boston University.