Misoprostol for the Treatment of Incomplete Abortion

Abortion, Incomplete Clinical Trial

Official title:

Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670761
• Other study ID #: 2.2.1
• Status: Completed
• Phase: N/A
• First received: April 29, 2008
• Last updated: July 26, 2016
• Start date: July 2004
• Est. completion date: December 2010

Study information

• Verified date: July 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMozambique: Maputo Health Directorate, Maputo, MozambiqueVietnam: Tu Du Hospital, VietnamMadagascar: Comité d'Ethique du Ministère de la Santé, MadagascarMoldova: Municipal Clinical Hospital No. 1 Ethics Comittee, Moldova, Republic ofTanzania: Western Institutional Review BoardBurkina Faso: Burkina Faso Ministry of Health Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Not available

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Incomplete

Intervention

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

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

Locations

Country	Name	City	State
Burkina Faso	Hôpital de District Sanitaire Dandé	Bobo Dioulasso
Burkina Faso	Hôpital de District Sanitaire de Ziniaré	Ouagadougou
Madagascar	Befelatanana Maternity Centre	Antananarivo
Moldova, Republic of	Municipal Clinical Hospital	Chishinau
Mozambique	Jose Macamo Hospital	Maputo
Tanzania	Kagera Regional Hospital	Bukoba

Sponsors (10)

Lead Sponsor	Collaborator
Gynuity Health Projects	Befelatanana Maternity Centre, Cuchi General District hospital, Hôpital de District Sanitaire Dandé, Hôpital de District Sanitaire de Ziniaré, Jose Macamo Hospital, Kagera Regional Hospital, Municipal Clinical Hospital No. 1, National OBGYN hospital, Tudu hospital

Countries where clinical trial is conducted

Burkina Faso,  Madagascar,  Moldova, Republic of,  Mozambique,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes