Skip to main content
OpenTrials
Completed

NCT Number: NCT02299401

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Reproductive Health Clinic, La Paz, Pedro Domingo Murillo, Bolivia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Women will receive three 800 mcg doses of misoprostol.

Semi-quantitative pregnancy test

Device

All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.

Other names: SQPT

Primary outcomes

  1. 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

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

    Time frame: 1-2 weeks

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

  2. Reported acceptability and satisfaction with misoprostol regimen

    Time frame: 1-2 weeks

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

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2014
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.