A Randomized Trial of Induction Methods in Premature Rupture of Membranes

November 14, 2018 updated by: Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • Recruiting
        • Doga
        • Contact:
        • Contact:
          • Doga Seckin
        • Sub-Investigator:
          • Doga Seckin
    • Uskudar
      • Istanbul, Uskudar, Turkey, 34668
        • Recruiting
        • zeynep kamil education and research hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. singleton pregnancy,
  2. gestational age ≥34 weeks,
  3. rupture of membranes,
  4. cephalic presentation,
  5. bishop score ≤5,
  6. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

  1. Patients who had contraindications for vaginal delivery,
  2. previous uterine surgery,
  3. fetal malpresentation,
  4. multifetal pregnancy,
  5. more than three contractions in 10 minutes,
  6. contraindications to prostaglandins,
  7. a category II or III fetal heart rate pattern,
  8. anomalous fetus,
  9. fetal demise
  10. women with immediate delivery indications -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PGE2 with Foley balloon catheter
10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
Device: Foley balloon catheter
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
No Intervention: PGE2 vaginal ovule
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction-to- delivery time
Time Frame: an average of one year
the length of time between the beginning of induction and the end of labor
an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tachysystole
Time Frame: an average of one year
uterine contractions more than 3 in 10 minutes
an average of one year
chorioamnionitis
Time Frame: an average of one year
clinical chorioamnionitis(Maternal fever and Fetal tachycardia >160/min and Maternal tachycardia >100/min
an average of one year
postpartum hemorrhage
Time Frame: an average of one year
abnormal uterine bleeding after birth
an average of one year
neonatal outcome
Time Frame: an average of one year
APGAR scores
an average of one year
admission to neonatal intensive care unit
Time Frame: an average of one year
admission to neonatal intensive care unit
an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Study Director: ahmet eser, Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2018

Primary Completion (Anticipated)

December 15, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47 (Other Identifier: IASO Thessalias)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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