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

April 29, 2008
September 20, 2012
July 2004
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00670761 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Misoprostol for the Treatment of Incomplete Abortion
Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

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.

Not available

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abortion, Incomplete
  • Drug: misoprostol
    comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
    Other Name: Cytotec
  • Procedure: MVA
    comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
  • Active Comparator: 1
    treatment with 600mcg oral misoprostol
    Intervention: Drug: misoprostol
  • Active Comparator: 2
    treatment with 400mcg sublingual misoprostol
    Intervention: Drug: misoprostol
  • Active Comparator: 3
    treatment with Manual Vacuum Aspiration (MVA)
    Intervention: Procedure: MVA
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
December 2010
April 2010   (final data collection date for primary outcome measure)

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;
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Madagascar,   Moldova, Republic of,   Mozambique,   Tanzania
 
NCT00670761
2.2.1
No
Melanie Pena, Gynuity Health Projects
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
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Gynuity Health Projects
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP