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Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.

Sponsor
Nwali Matthew Igwe (Other)
Overall Status
Completed
CT.gov ID
NCT02574338
Collaborator
(none)
135
Enrollment
1
Location
2
Arms
35
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.

Condition or Disease Intervention/Treatment Phase
  • Device: Foley's Catheter
  • Drug: prostaglandin E1 analogue
 N/A

Detailed Description

This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: group - 1 Foley's Catheter

will have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours

Device: Foley's Catheter
intracervical extraamniotic Foley's catheter
Active Comparator: Group - 2 Prostaglandin E1 Analogue

will have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours)

Drug: prostaglandin E1 analogue
intravaginal misoprostol
Other Names:
  • Misoprostol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bishop Score of 6 or more [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Parturients who gave consent

    • has low bishop score (≤5)

    • term singleton cephalic presenting fetus

    • intact membranes

    • no contraindication to vaginal delivery

    Exclusion Criteria:

    • those who refused consent

    • preterm delivery

    • vaginal infection

    • non-cephalic presentation

    • multiple gestation

    • low lying placenta/previa,

    • vaginal bleeding,

    • previous cesarean section

    • rupture of membranes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal Teaching Hospital, Abakaliki Abakaliki Ebonyi Nigeria 480001

    Sponsors and Collaborators

    • Nwali Matthew Igwe

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nwali Matthew Igwe, Dr, Federal Teaching Hospital Abakaliki
    ClinicalTrials.gov Identifier:
    NCT02574338
    Other Study ID Numbers:
    • MSFC-2015-CT
    First Posted:
    Oct 12, 2015
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Alprostadil
    Misoprostol

    Study Results

    No Results Posted as of Oct 15, 2019