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

November 2, 2016 updated by: Gynuity Health Projects

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
    • Pedro Domingo Murillo
      • La Paz, Pedro Domingo Murillo, Bolivia
        • Reproductive Health Clinic
  • Ecuador
      • Quito, Ecuador
        • Reproductive Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buccal
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.
Drug: Misoprostol
Women will receive three 800 mcg doses of misoprostol.
Device: Semi-quantitative pregnancy test
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
Other Names:
  • SQPT
Experimental: Sublingual
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.
Drug: Misoprostol
Women will receive three 800 mcg doses of misoprostol.
Device: Semi-quantitative pregnancy test
All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
Other Names:
  • SQPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-2 weeks
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.
1-2 weeks
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.
1-2 weeks
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.
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Investigators

  • Study Director: Wendy R Sheldon, PhD, Gynuity Health Projects

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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