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A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Primary Purpose

Preterm Premature Rupture of Fetal Membranes, Induction of Labor Affected Fetus / Newborn

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foley balloon catheter
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Premature Rupture of Fetal Membranes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • DogaRecruiting
  • Zeynep Kamil Education and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PGE2 with Foley balloon catheter

PGE2 vaginal ovule

Arm Description

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

10 mg PGE2 vaginal ovule will be inserted to the posterior fornix

Outcomes

Primary Outcome Measures

induction-to- delivery time
the length of time between the beginning of induction and the end of labor

Secondary Outcome Measures

tachysystole
uterine contractions more than 3 in 10 minutes
chorioamnionitis
clinical chorioamnionitis(Maternal fever and Fetal tachycardia >160/min and Maternal tachycardia >100/min
postpartum hemorrhage
abnormal uterine bleeding after birth
neonatal outcome
APGAR scores
admission to neonatal intensive care unit
admission to neonatal intensive care unit

Full Information

First Posted
March 27, 2018
Last Updated
November 14, 2018
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03744078
Brief Title
A Randomized Trial of Induction Methods in Premature Rupture of Membranes
Official Title
A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Fetal Membranes, Induction of Labor Affected Fetus / Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PGE2 with Foley balloon catheter
Arm Type
Active Comparator
Arm Description
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
Arm Title
PGE2 vaginal ovule
Arm Type
No Intervention
Arm Description
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix
Intervention Type
Device
Intervention Name(s)
Foley balloon catheter
Intervention Description
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
Primary Outcome Measure Information:
Title
induction-to- delivery time
Description
the length of time between the beginning of induction and the end of labor
Time Frame
an average of one year
Secondary Outcome Measure Information:
Title
tachysystole
Description
uterine contractions more than 3 in 10 minutes
Time Frame
an average of one year
Title
chorioamnionitis
Description
clinical chorioamnionitis(Maternal fever and Fetal tachycardia >160/min and Maternal tachycardia >100/min
Time Frame
an average of one year
Title
postpartum hemorrhage
Description
abnormal uterine bleeding after birth
Time Frame
an average of one year
Title
neonatal outcome
Description
APGAR scores
Time Frame
an average of one year
Title
admission to neonatal intensive care unit
Description
admission to neonatal intensive care unit
Time Frame
an average of one year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: singleton pregnancy, gestational age ≥34 weeks, rupture of membranes, cephalic presentation, bishop score ≤5, had less than three uterine contractions in every 10 minutes. Exclusion Criteria: Patients who had contraindications for vaginal delivery, previous uterine surgery, fetal malpresentation, multifetal pregnancy, more than three contractions in 10 minutes, contraindications to prostaglandins, a category II or III fetal heart rate pattern, anomalous fetus, fetal demise women with immediate delivery indications -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmet eser
Phone
905067136880
Email
hicoice@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
and yavuz
Phone
905062224075
Email
andyavuz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmet eser
Organizational Affiliation
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Doga
City
Istanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doga Seckin
Phone
905065152715
Email
doga_seckin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Doga Seckin
First Name & Middle Initial & Last Name & Degree
Doga Seckin
Facility Name
Zeynep Kamil Education and Research Hospital
City
Istanbul
State/Province
Uskudar
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmet eser
Phone
905067136880
Email
hicoice@yahoo.com
First Name & Middle Initial & Last Name & Degree
ahmet eser
Email
hicoice@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Randomized Trial of Induction Methods in Premature Rupture of Membranes

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