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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Family Planning Fellowship
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01356927
First received: May 18, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Medical Abortion, Complete or Unspecified, Without Complication
Drug: DMPA
Drug: Etonogestrel implant
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Satisfaction with timing of contraceptive administration [ Time Frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Continuation rate of contraceptive method [ Time Frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days of bleeding [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Follow-up rate after abortion [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Failure of medical abortion [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Reasons for non-enrollment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 Name: Depo Provera
Experimental: 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 Name: Implanon

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356927

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Family Planning Fellowship
Investigators
Principal Investigator: Principal Investigator Boston University
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01356927     History of Changes
Other Study ID Numbers: H-30255
Study First Received: May 18, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
long acting reversible contraception
medical abortion
DMPA
etonogestrel implant
Implanon
contraceptive continuation

Additional relevant MeSH terms:
Mifepristone
Desogestrel
Medroxyprogesterone Acetate
3-keto-desogestrel
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins
Hormones

ClinicalTrials.gov processed this record on October 16, 2014