Misoprostol for the Treatment of Incomplete Abortion
Information source: Gynuity Health Projects
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abortion, Incomplete
Intervention: misoprostol (Drug); MVA (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Gynuity Health Projects Official(s) and/or principal investigator(s):
Beverly Winikoff, MD, MPH, Principal Investigator, Affiliation: Gynuity Health Projects
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.
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.
Clinical Details
Official title: Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
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;
Locations and Contacts
Befelatanana Maternity Centre, Antananarivo, Madagascar
Municipal Clinical Hospital, Chishinau, Moldova, Republic of
Jose Macamo Hospital, Maputo, Mozambique
Kagera Regional Hospital, Bukoba, Tanzania
Additional Information
Starting date: July 2004
Ending date: April 2007
Last updated: May 1, 2008
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