Clincosm LogoSign in Get a demo

Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.

Sponsor
Saint Thomas Hospital, Panama (Other)
Overall Status
Completed
CT.gov ID
NCT03489798
Collaborator
Sistema Nacional de Investigadores de Panamá (Other)
310
Enrollment
1
Location
2
Arms
5.4
Actual Duration (Months)
57.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 6 misoprostol
  • Procedure: 3 misoprostol
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
310 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.
Actual Study Start Date :
Apr 5, 2018
Actual Primary Completion Date :
May 31, 2018
Actual Study Completion Date :
Sep 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6 Misoprostol

Up to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.

Procedure: 6 misoprostol
Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
Other Names:
  • Prostaglandin E1 25 ug dose

    		•
    Active Comparator: 3 misoprostol

    Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.

    Procedure: 3 misoprostol
    Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
    Other Names:
  • Prostaglandin E1 25 ug dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vaginal birth [48 hours]

      Number of patients that had a vaginal birth

    Secondary Outcome Measures

    1. Maternal complications [48 hours]

      Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony).

    2. Fetal complications [48 hours]

      Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pregnant women between 34 and 42 weeks of gestation.

    • Obstetric indication for termination of pregnancy.

    • No fetal evidence of fetal distress

    Exclusion Criteria:

    • Any contraindication for the use of misoprostol.

    • Oligohydramnios.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Thomas Maternity Hospital Panama Panama

    Sponsors and Collaborators

    • Saint Thomas Hospital, Panama
    • Sistema Nacional de Investigadores de Panamá

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osvaldo A. Reyes T., Investigator - Head: Research Department, Saint Thomas Hospital, Panama
    ClinicalTrials.gov Identifier:
    NCT03489798
    Other Study ID Numbers:
    • MHST2016-04
    First Posted:
    Apr 5, 2018
    Last Update Posted:
    Oct 12, 2018
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Osvaldo A. Reyes T., Investigator - Head: Research Department, Saint Thomas Hospital, Panama
    Induction of labor
    Misoprostol
    Failed induction
    Additional relevant MeSH terms:
    Alprostadil
    Misoprostol

    Study Results

    No Results Posted as of Oct 12, 2018