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

Gynuity Health Projects401 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

401

Conditions

Pregnancy

Interventions

Misoprostol

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (2)

Reproductive Health Clinic

La Paz, Pedro Domingo Murillo, Bolivia

Reproductive Health Clinic

Quito, Ecuador

Outcomes

Primary Outcomes

Ongoing pregnancy rates

The study will assess and compare the rates of ongoing pregnancy for the two medical abortion regimens at 1-2 week follow up.

Time frame: 1-2 weeks

Secondary Outcomes

Incidence of side effects and complications as a measure of safety/ side effects

Assess and compare the safety/side effects of two regimens of misoprostol alone for early pregnancy termination.

Time frame: 1-2 weeks

Reported acceptability and satisfaction with misoprostol regimen

The study will also assess and compare satisfaction and acceptability of each medical abortion regimen as rated by the women.

Time frame: 1-2 weeks

Usability of SQPT as measured by women's ability to assess success of medical abortion procedure at home

The study will assess women's ability to use the SQPT effectively for at-home assessment of the success of the medical abortion procedure.

Time frame: 1-2 weeks

Self-reported acceptability and satisfaction with SQPT as a means of at-home follow up

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.

Time frame: 1-2 weeks