Misoprostol for the Treatment of Incomplete Abortion
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Purpose
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:
- 600 mcg of oral misoprostol in one dose, or
- Standard surgical treatment (MVA)
In Moldova and Madagascar:
- 600 mcg of oral misoprostol in one dose, or
- 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.
| Condition | Intervention |
|---|---|
|
Abortion, Incomplete |
Drug: misoprostol Procedure: MVA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options |
- complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason [ Time Frame: one week after initial treatment with the option of an additional week ] [ Designated as safety issue: Yes ]
| Enrollment: | 720 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
treatment with 600mcg oral misoprostol
|
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Other Name: Cytotec
|
|
Active Comparator: 2
treatment with 400mcg sublingual misoprostol
|
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Other Name: Cytotec
|
|
Active Comparator: 3
treatment with Manual Vacuum Aspiration (MVA)
|
Procedure: MVA
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
|
Detailed Description:
Not available
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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
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:
- foul smelling discharge,
- fever > 39 degrees C ,
- pulse >110/min;
Contacts and Locations| Burkina Faso | |
| Hôpital de District Sanitaire Dandé | |
| Bobo Dioulasso, Burkina Faso | |
| Hôpital de District Sanitaire de Ziniaré | |
| Ouagadougou, Burkina Faso | |
| Madagascar | |
| Befelatanana Maternity Centre | |
| Antananarivo, Madagascar | |
| Moldova, Republic of | |
| Municipal Clinical Hospital | |
| Chishinau, Moldova, Republic of | |
| Mozambique | |
| Jose Macamo Hospital | |
| Maputo, Mozambique | |
| Tanzania | |
| Kagera Regional Hospital | |
| Bukoba, Tanzania | |
| Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects |
More Information
No publications provided
| Responsible Party: | Melanie Pena, Director, Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT00670761 History of Changes |
| Other Study ID Numbers: | 2.2.1 |
| Study First Received: | April 29, 2008 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Institutional Review Board Mozambique: Maputo Health Directorate, Maputo, Mozambique Vietnam: Tu Du Hospital, Vietnam Madagascar: Comité d'Ethique du Ministère de la Santé, Madagascar Moldova: Municipal Clinical Hospital No. 1 Ethics Comittee, Moldova, Republic of Tanzania: Western Institutional Review Board Burkina Faso: Burkina Faso Ministry of Health Ethical Review Board |
Keywords provided by Gynuity Health Projects:
|
misoprostol incomplete abortion sublingual postabortion care MVA |
Additional relevant MeSH terms:
|
Abortion, Incomplete Abortion, Spontaneous Pregnancy Complications Misoprostol Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
Pharmacologic Actions Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 21, 2013