Misoprostol for the Treatment of Incomplete Abortion

Not Applicable

Completed

• Conditions: Abortion, Incomplete
• Interventions: Procedure: MVA; Drug: misoprostol

• Registration Number: NCT00670761
• Lead Sponsor: Gynuity Health Projects

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. 600 mcg of oral misoprostol in one dose, or

2. Standard surgical treatment (MVA)

In Moldova and Madagascar:

1. 600 mcg of oral misoprostol in one dose, or

2. 400 mcg of sublingual misoprostol in one dose.

In Burkina Faso and Vietnam:

1. 400 mcg of sublingual misoprostol in one dose.

We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Primary Completion: 2010-04
• Study Completion: 2010-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 720

Inclusion Criteria

• If no ultrasound used:

  1. Past or present history of vaginal bleeding during pregnancy; and
  2. Open cervical os.

• If ultrasound used:

  1. Past or present history of vaginal bleeding during pregnancy; and
  2. 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

Exclusion Criteria

• 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:

  1. foul smelling discharge,
  2. fever > 39 degrees C ,
  3. pulse >110/min;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	MVA	treatment with Manual Vacuum Aspiration (MVA)
1	misoprostol	treatment with 600mcg oral misoprostol
2	misoprostol	treatment with 400mcg sublingual misoprostol

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Kagera Regional Hospital; 🇹🇿 Bukoba, Tanzania

Hôpital de District Sanitaire Dandé; 🇧🇫 Bobo Dioulasso, Burkina Faso

Befelatanana Maternity Centre; 🇲🇬 Antananarivo, Madagascar

Jose Macamo Hospital; 🇲🇿 Maputo, Mozambique

Hôpital de District Sanitaire de Ziniaré; 🇧🇫 Ouagadougou, Burkina Faso

Municipal Clinical Hospital; 🇲🇩 Chishinau, Moldova, Republic of