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Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

Sponsor
Gynuity Health Projects (Other)
Overall Status
Completed
CT.gov ID
NCT00674232
Collaborator
(none)
311
Enrollment
3
Locations
2
Arms
17
Duration (Months)
103.7
Patients Per Site
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

Condition or Disease Intervention/Treatment Phase
  • Drug: 600 mcg misoprostol
  • Procedure: Surgical treatment
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
311 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Misoprostol for Treatment of Incomplete Abortion
Study Start Date :
May 1, 2006
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Misoprostol

Group 1 randomized to take single dose of 600 mcg oral misoprostol

Drug: 600 mcg misoprostol
single dose of misoprostol taken orally
Other Names:
  • Cytotec

    		•
    Other: Surgical treatment

    Group 2 randomized to receive standard surgical treatment as per local protocol (D&C or MVA)

    Procedure: Surgical treatment
    Either dilation and curettage or manual vacuum aspiration, as per local protocol
    Other Names:
  • D&C, MVA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason [one week after initial treatment]

    Secondary Outcome Measures

    1. side effects [measured at follow up visit one week after initial treatment]

    2. acceptability [measured at follow up visit one week after initial treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • past or present history of vaginal bleeding during pregnancy

    • open cervical os

    • evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)

    • surgical evacuation of the uterus would be advised as course of action if misoprostol was not available

    • generally in good health

    • woman lives or works within one hour of study site

    • woman willing to provide contact information for follow up purposes

    • informed consent given

    Exclusion Criteria:

    • contraindications to study drug

    • uterine size larger than 12 weeks LMP

    • signs of severe infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital del Dia, CEMOPLAF Quito Ecuador
    2 Hospital Gineco-obstetrico Isidro Ayora Quito Ecuador
    3 Hospital Maternidad Concepcion Palacios Caracas Venezuela

    Sponsors and Collaborators

    • Gynuity Health Projects

    Investigators

    • Study Director: Melanie Peña, MPH, MA, Gynuity Health Projects
    • Study Director: Jill Durocher, Gynuity Health Projects

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00674232
    Other Study ID Numbers:
    • 2.2.0
    First Posted:
    May 7, 2008
    Last Update Posted:
    May 7, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    incomplete abortion
    spontaneous miscarriage
    Additional relevant MeSH terms:
    Abortion, Incomplete
    Misoprostol

    Study Results

    No Results Posted as of May 7, 2008