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Misoprostol for the Treatment of Incomplete Abortion

This study has been completed.

Sponsors and Collaborators: Gynuity Health Projects
Befelatanana Maternity Centre Antananarivo, Madagascar
Municipal Clinical Hospital No. 1, Chisinau, Republic of Moldova
Kagera Regional Hospital, Bukoba, Tanzania
Jose Macamo Hospital, Maputo Mozambique
Information provided by: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00670761
  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:

  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.


Condition Intervention
Abortion, Incomplete
Drug: misoprostol
Procedure: MVA

MedlinePlus related topics:   Abortion    Pregnancy Loss   

ChemIDplus related topics:   Misoprostol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:   Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • 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:   April 2007
Primary Completion Date:   April 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
treatment with 600mcg oral misoprostol
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
2: Active Comparator
treatment with 400mcg sublingual misoprostol
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
3: Active Comparator
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)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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;
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670761

Locations
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

Sponsors and Collaborators
Gynuity Health Projects
Befelatanana Maternity Centre Antananarivo, Madagascar
Municipal Clinical Hospital No. 1, Chisinau, Republic of Moldova
Kagera Regional Hospital, Bukoba, Tanzania
Jose Macamo Hospital, Maputo Mozambique

Investigators
Principal Investigator:     Beverly Winikoff, MD, MPH     Gynuity Health Projects    
  More Information

Responsible Party:   Gynuity Health Projects ( Beverly Winikoff, MD, MPH )
Study ID Numbers:   2.2.1
First Received:   April 29, 2008
Last Updated:   May 1, 2008
ClinicalTrials.gov Identifier:   NCT00670761
Health Authority:   United States: Institutional Review Board;   Mozambique: Maputo Health Directorate, Maputo, Mozambique;   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

Keywords provided by Gynuity Health Projects:
misoprostol  
incomplete abortion  
sublingual  
postabortion care  
MVA  

Study placed in the following topic categories:
Pregnancy Complications
Misoprostol
Abortion, Spontaneous
Abortion, Incomplete

Additional relevant MeSH terms:
Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents
Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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