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

This study has been completed.
Sponsor:
Collaborator:
Family Planning Fellowship
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01356927
First received: May 18, 2011
Last updated: April 6, 2017
Last verified: April 2017
  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 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.


Condition Intervention
Abortion; Induced Drug: DMPA Drug: Etonogestrel implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 ]
  • Continuation rate of contraceptive method [ Time Frame: 7 days, 14 days, 28 days, 3, 6, 9, 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: May 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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: Sarita Sonalkar, MD Boston University
  More Information

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: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Etonogestrel
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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 August 21, 2017