Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Satisfaction with timing of contraceptive administration
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Desiring and eligible for medication abortion
- •Desiring and eligible for etonogestrel implant or DMPA
排除标准
- •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
研究组 & 干预措施
DMPA
DMPA given at the time of mifepristone for medical abortion
干预措施: DMPA (Drug)
Etonogestrel implant
Etonogestrel implant placed at the time of mifepristone for medical abortion
干预措施: Etonogestrel implant (Drug)
结局指标
主要结局
Satisfaction with timing of contraceptive administration
时间窗: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
Continuation rate of contraceptive method
时间窗: 7 days, 14 days, 28 days, 3, 6, 9, 12 months
次要结局
- Follow-up rate after abortion(14 days)
- Failure of medical abortion(7 days)
- Reasons for non-enrollment(1 year)
- Number of days of bleeding(28 days)