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

Gynuity Health Projects

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pregnancy

Treatments: Drug: Misoprostol; Device: Semi-quantitative pregnancy test

Study type: Interventional

Funder types: Other

Identifiers

NCT02299401

6006

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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401 participants in 2 patient groups

Buccal

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol

Device: Semi-quantitative pregnancy test

Sublingual

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol

Device: Semi-quantitative pregnancy test