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Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

Sponsor
Hawler Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT00892229
Collaborator
NEGATIVE (Other)
100
Enrollment
1
Location
3
Arms
12
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.

Condition or Disease Intervention/Treatment Phase
  • Drug: Misoprostol (given buccally)
  • Drug: Misoprostol (given vaginally)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Buccal Misoprostol

Group one: 50 patients with first trimester missed abortion received buccal misoprostol

Drug: Misoprostol (given buccally)
400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
Other Names:
  • serial number 022-00

    		•
    Active Comparator: Vaginal Misoprostol

    Group two: 5 patients received vaginal misoprostol

    Drug: Misoprostol (given vaginally)
    400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
    Other Names:
  • serial number 022-00

    		•
    Active Comparator: Buccal and Vaginal Misoprostol

    50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects. Each group was randomly allocated (1,3,5,... for the buccal group & 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol.

    Drug: Misoprostol (given buccally)
    400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
    Other Names:
  • serial number 022-00

    • Drug: Misoprostol (given vaginally)
    400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
    Other Names:
  • serial number 022-00

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.) [March 2007 to March 2008]

    Secondary Outcome Measures

    1. The secondary objectives are to compare the side effects and acceptability by the subjects. [March 2007 to March 2008]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • first trimester missed abortion
    Exclusion Criteria:

    • history or evidence of disorders that represent contraindication to the use of misoprostol:

    • severe pulmonary diseases

    • congenital or acquired heart diseases

    • glaucoma

    • prolonged use of corticosteroid

    • sickle cell anemia and adrenal insufficiency

    • smokers

    • known hypersensitivity to drugs

    • any evidence of infection

    • patient's refusal to participate in the study

    • patients with abnormal results of investigations

    • patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage

    • patients with complete abortion

    • patients with severe bleeding that required emergency surgical evacuation of the uterus

    • patients with partially dissolved tablets at the site of application in both groups

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Iraqi Medical Specialization Risafa Baghdad Iraq 00964

    Sponsors and Collaborators

    • Hawler Medical University
    • NEGATIVE

    Investigators

    • Principal Investigator: BASHAR Y F HANOOSHI, CABOG, IRAQI MEDICAL SPECIALIZATION/IRAQ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00892229
    Other Study ID Numbers:
    • IMS - 1769
    First Posted:
    May 4, 2009
    Last Update Posted:
    May 4, 2009
    Last Verified:
    May 1, 2009
    Keywords provided by , ,
    First trimester missed abortion
    Misoprostol
    buccal
    vaginal
    cervical ripening
    first trimester
    missed abortion
    Additional relevant MeSH terms:
    Abortion, Missed
    Misoprostol

    Study Results

    No Results Posted as of May 4, 2009