Same-day Long-acting Reversible Contraception for Medication Abortion

NCT01356927 | Completed

• 1 other identifier: H-30255
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abortion; Induced

Keywords

long acting reversible contraception; medical abortion; DMPA; etonogestrel implant; Implanon; contraceptive continuation

Outcome Measures

Primary Outcomes (2)

• Satisfaction with timing of contraceptive administration

  7 days, 14 days, 28 days, 3, 6, 9, 12 months

• Continuation rate of contraceptive method

  7 days, 14 days, 28 days, 3, 6, 9, 12 months

Secondary Outcomes (4)

• Number of days of bleeding

  28 days

• Follow-up rate after abortion

  14 days

• Failure of medical abortion

  7 days

• Reasons for non-enrollment

  1 year

Study Arms (2)

DMPA

DMPA given at the time of mifepristone for medical abortion

Drug: DMPA

Etonogestrel implant

Etonogestrel implant placed at the time of mifepristone for medical abortion

Drug: Etonogestrel implant

Interventions

DMPA DRUG

DMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion

Also known as: Depo Provera

DMPA

Etonogestrel implant DRUG

Etonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion

Also known as: Implanon

Etonogestrel implant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• Family Planning Fellowship: collaborator

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Sonalkar S, McClusky J, Hou MY, Borgatta L. Administration of depot medroxyprogesterone acetate on the day of mifepristone for medical abortion: a pilot study. Contraception. 2015 Feb;91(2):174-7. doi: 10.1016/j.contraception.2014.10.010. Epub 2014 Nov 6.

  PMID: 25481376 DERIVED

• Sonalkar S, Hou MY, Borgatta L. Administration of the etonogestrel contraceptive implant on the day of mifepristone for medical abortion: a pilot study. Contraception. 2013 Nov;88(5):671-3. doi: 10.1016/j.contraception.2013.07.008. Epub 2013 Jul 29.

  PMID: 24028749 DERIVED

MeSH Terms

Interventions

N,N-dimethyl-4-anisidine; Medroxyprogesterone Acetate; etonogestrel

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sarita Sonalkar, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)