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Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

Sponsor
China Medical University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00695331
Collaborator
(none)
143
Enrollment
1
Location
2
Arms
11
Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.

In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
Study Start Date :
Feb 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2008
Anticipated Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Titrated Oral Misoprostol Solution

Drug: Misoprostol
Titrated Misoprostol Solution
Other Names:
  • Cytotec

    		•
    Active Comparator: 2

    Intravenous Oxytocin

    Drug: Oxytocin
    Titrated Intravenous Oxytocin
    Other Names:
  • Piton-S

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the percentage of women delivering infants vaginally within 12 hours of augmentation [post vaginal delivery]

    Secondary Outcome Measures

    1. uterine hyperstimulation rate [post vaginal delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pregnancy between 36 and 42 weeks of gestation

    • Live singleton

    • Cephalic presentation

    • A reassuring fetal heart rate pattern

    • Bishop score greater than 6

    • Inadequate uterine contraction (less than or equal to 2 per 10 minutes)

    Exclusion Criteria:

    • Nonreassuring fetal heart rate pattern

    • Parity more than five

    • Uterine scar

    • Suspected placental abruption with abnormal fetal heart rate

    • Vaginal bleeding other than "bloody show"

    • Significant maternal cardiac, renal, or hepatic disease

    • hypersensitivity to oxytocin, misoprostol or prostaglandin analogues

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital Taichung Taiwan 404

    Sponsors and Collaborators

    • China Medical University Hospital

    Investigators

    • Study Chair: Shi-Yann Cheng, MD, China Medical University Beigang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00695331
    Other Study ID Numbers:
    • CMUBH R96007
    • DMR96-IRB-176
    First Posted:
    Jun 11, 2008
    Last Update Posted:
    Jul 10, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Labor Augmentation
    Misoprostol
    Oxytocin
    Additional relevant MeSH terms:
    Misoprostol
    Oxytocin

    Study Results

    No Results Posted as of Jul 10, 2008