NCT00670761

Brief Summary

This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion. Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens: In Tanzania and Mozambique:

  1. 1.600 mcg of oral misoprostol in one dose, or
  2. 2.Standard surgical treatment (MVA)
  3. 3.600 mcg of oral misoprostol in one dose, or
  4. 4.400 mcg of sublingual misoprostol in one dose.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
4 countries

5 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

Study Start

First participant enrolled

July 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

5.8 years

First QC Date

April 29, 2008

Last Update Submit

July 26, 2016

Conditions

Abortion, Incomplete

Keywords

misoprostolincomplete abortionsublingualpostabortion careMVA

Outcome Measures

Primary Outcomes (1)

  • complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason

    one week after initial treatment with the option of an additional week

Study Arms (3)

1

ACTIVE COMPARATOR

treatment with 600mcg oral misoprostol

Drug: misoprostol

2

ACTIVE COMPARATOR

treatment with 400mcg sublingual misoprostol

Drug: misoprostol

3

ACTIVE COMPARATOR

treatment with Manual Vacuum Aspiration (MVA)

Procedure: MVA

Interventions

misoprostolDRUG

comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

Also known as: Cytotec
12
MVAPROCEDURE

comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • If no ultrasound used:
  • Past or present history of vaginal bleeding during pregnancy; and
  • Open cervical os.
  • If ultrasound used:
  • Past or present history of vaginal bleeding during pregnancy; and
  • Evidence of incomplete abortion with substantial debris in the uterus.
  • All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
  • Willing to provide contact information for purposes of follow-up.
  • In Tanzania: 18 years of age or over or parental permission
  • In Mozambique: 21 years of age or over or parental permission
  • In Moldova: 18 years of age or over
  • In Madagascar: 18 years of age or parental permission
  • In Vietnam: reproductive age

You may not qualify if:

  • Contraindications to the study drug;
  • Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
  • Signs of severe infection, defined as at least one of the following of:
  • foul smelling discharge,
  • fever \> 39 degrees C ,
  • pulse \>110/min;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital de District Sanitaire Dandé

Bobo-Dioulasso, Burkina Faso

Location

Hôpital de District Sanitaire de Ziniaré

Ouagadougou, Burkina Faso

Location

Befelatanana Maternity Centre

Antananarivo, Madagascar

Location

Municipal Clinical Hospital

Chishinau, Moldova

Location

Jose Macamo Hospital

Maputo, Mozambique

Location

Kagera Regional Hospital

Bukoba, Tanzania

Location

Related Publications (1)

  • Ngoc NT, Shochet T, Blum J, Hai PT, Dung DL, Nhan TT, Winikoff B. Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting. BMC Pregnancy Childbirth. 2013 May 22;13:118. doi: 10.1186/1471-2393-13-118.

    PMID: 23697561DERIVED

MeSH Terms

Conditions

Abortion, Incomplete

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 2, 2008

Study Start

July 1, 2004

Primary Completion

April 1, 2010

Study Completion

December 1, 2010

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations

MA(1)MO(1)TA(1)BU(2)