Effectiveness of Two Regimens of Misoprostol Alone for Early Pregnancy Termination and Use of SQPT for At-Home Follow-Up

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Misoprostol

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