Assessing the Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of a Semi-Quantitative Pregnancy Test for At-Home Follow-Up
Overview
- Phase
- Phase 2
- Intervention
- Misoprostol
- Conditions
- Pregnancy
- Sponsor
- Gynuity Health Projects
- Enrollment
- 401
- Locations
- 1
- Primary Endpoint
- Ongoing pregnancy rates
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This randomized trial will compare the rates of ongoing pregnancy, safety/side effects and acceptability of two medical abortion regimens that are commonly used in Latin America. The first regimen will involve three 800 mcg doses of misoprostol taken buccally in three hour intervals; the second will involve three 800 mcg doses of misoprostol taken sublingually in three hour intervals. This study will also aim to assess the feasibility and acceptability of a semi-quantitative pregnancy test (SQPT) for at-home follow-up in both settings.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Presents for voluntary termination of pregnancy
- •Gestational age ≤ 70 days by last menstrual period plus clinical assessment or ultrasound
- •General good health including the absence of conditions which contraindicate the use of misoprostol for pregnancy termination
- •Agrees to return for follow-up visit and willing to provide an address and/or telephone number for the purposes of follow-up
- •Able to consent to study participation
Exclusion Criteria
- •Gestational age \> 70 days last menstrual period
- •Confirmed or suspected ectopic or molar pregnancy
- •Contraindications to medical abortion include having an intrauterine device in place and history of allergy to misoprostol or other prostaglandins
Arms & Interventions
Buccal
Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
Intervention: Misoprostol
Buccal
Women randomized to receive three 800 mcg doses of misoprostol taken buccally in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
Intervention: Semi-quantitative pregnancy test
Sublingual
Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
Intervention: Misoprostol
Sublingual
Women randomized to receive three 800 mcg doses of misoprostol taken sublingually in three hour intervals. All women receive a semi-quantitative pregnancy test for at-home follow up.
Intervention: Semi-quantitative pregnancy test
Outcomes
Primary Outcomes
Ongoing pregnancy rates
Time Frame: 1-2 weeks
The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up.
Secondary Outcomes
- Incidence of side effects and complications as a measure of safety/ side effects(1-2 weeks)
- Reported acceptability and satisfaction with misoprostol regimen(1-2 weeks)
- Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home(1-2 weeks)
- Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up(1-2 weeks)