Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
720 participants
INTERVENTIONAL
2004-07-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
treatment with 600mcg oral misoprostol
misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
2
treatment with 400mcg sublingual misoprostol
misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
3
treatment with Manual Vacuum Aspiration (MVA)
MVA
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Interventions
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misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
MVA
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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;
18 Years
FEMALE
Yes
Sponsors
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Befelatanana Maternity Centre
UNKNOWN
Municipal Clinical Hospital No. 1
UNKNOWN
Kagera Regional Hospital
OTHER
Jose Macamo Hospital
UNKNOWN
Tudu hospital
UNKNOWN
National OBGYN hospital
UNKNOWN
Cuchi General District hospital
UNKNOWN
Hôpital de District Sanitaire Dandé
UNKNOWN
Hôpital de District Sanitaire de Ziniaré
UNKNOWN
Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
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Hôpital de District Sanitaire Dandé
Bobo-Dioulasso, , Burkina Faso
Hôpital de District Sanitaire de Ziniaré
Ouagadougou, , Burkina Faso
Befelatanana Maternity Centre
Antananarivo, , Madagascar
Municipal Clinical Hospital
Chishinau, , Moldova
Jose Macamo Hospital
Maputo, , Mozambique
Kagera Regional Hospital
Bukoba, , Tanzania
Countries
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References
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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.
Other Identifiers
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2.2.1
Identifier Type: -
Identifier Source: org_study_id
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