NCT02299401

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for phase_2 pregnancy

Timeline
Completed

Started Dec 2014

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

November 13, 2014

Last Update Submit

November 2, 2016

Conditions

Pregnancy

Keywords

Medical abortionInduced abortionPregnancy testSemi-quantitative pregnancy test

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-2 weeks

Secondary Outcomes (4)

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

    1-2 weeks

  • Reported acceptability and satisfaction with misoprostol regimen

    1-2 weeks

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

    1-2 weeks

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

    1-2 weeks

Study Arms (2)

Buccal

EXPERIMENTAL

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: MisoprostolDevice: Semi-quantitative pregnancy test

Sublingual

EXPERIMENTAL

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: MisoprostolDevice: Semi-quantitative pregnancy test

Interventions

MisoprostolDRUG

Women will receive three 800 mcg doses of misoprostol.

BuccalSublingual
Semi-quantitative pregnancy testDEVICE

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

Also known as: SQPT
BuccalSublingual

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Health Clinic

La Paz, Pedro Domingo Murillo, Bolivia

Location

Reproductive Health Clinic

Quito, Ecuador

Location

Related Publications (1)

  • Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1.

    PMID: 30831103DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Wendy R Sheldon, PhD

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 24, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

BO(1)EC(1)