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

Phase 2

Completed

• Conditions: Pregnancy
• Interventions: Drug: Misoprostol; Device: Semi-quantitative pregnancy test

• Registration Number: NCT02299401
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2014-12
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 401

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buccal	Semi-quantitative pregnancy test	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.
Sublingual	Semi-quantitative pregnancy test	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.
Buccal	Misoprostol	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.
Sublingual	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rates	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 Outcome Measures

Name	Time	Method
Incidence of side effects and complications as a measure of safety/ side effects	1-2 weeks	Assess and compare the safety/side effects of two regimens of misoprostol alone for early pregnancy termination.
Reported acceptability and satisfaction with misoprostol regimen	1-2 weeks	The study will also assess and compare satisfaction and acceptability of each medical abortion regimen as rated by the women.
Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home	1-2 weeks	The study will assess women's ability to use the SQPT effectively for at-home assessment of the success of the medical abortion procedure.
Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up	1-2 weeks	The study will also assess the acceptability of the test as a means for at-home follow-up after medical abortion as rated by the women. The woman will answer questions about whether she found the SQPT easy to use an acceptable for at-home follow up.

Trial Locations

Locations (1)

Reproductive Health Clinic; 🇪🇨 Quito, Ecuador