Misoprostol for the Treatment of Incomplete Abortion

This study has been completed.
Sponsor:
Collaborators:
Befelatanana Maternity Centre
Municipal Clinical Hospital No. 1
Kagera Regional Hospital
Jose Macamo Hospital
Tudu hospital
National OBGYN hospital
Cuchi General District hospital
Hôpital de District Sanitaire Dandé
Hôpital de District Sanitaire de Ziniaré
Information provided by (Responsible Party):
Melanie Pena, Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00670761
First received: April 29, 2008
Last updated: September 20, 2012
Last verified: September 2012
  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.

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

Resource links provided by NLM:


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: 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
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
    • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Sponsors and Collaborators
Gynuity Health Projects
Befelatanana Maternity Centre
Municipal Clinical Hospital No. 1
Kagera Regional Hospital
Jose Macamo Hospital
Tudu hospital
National OBGYN hospital
Cuchi General District hospital
Hôpital de District Sanitaire Dandé
Hôpital de District Sanitaire de Ziniaré
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
  More Information

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 01, 2014