A Randomized Trial of Induction Methods in Premature Rupture of Membranes

NCT03744078 | Unknown DMC

• 1 other identifier: 47
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• induction-to- delivery time

  the length of time between the beginning of induction and the end of labor

  an average of one year

Secondary Outcomes (5)

• tachysystole

  an average of one year

• chorioamnionitis

  an average of one year

• postpartum hemorrhage

  an average of one year

• neonatal outcome

  an average of one year

• admission to neonatal intensive care unit

  an average of one year

Study Arms (2)

PGE2 with Foley balloon catheter

ACTIVE COMPARATOR

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

PGE2 vaginal ovule

NO INTERVENTION

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

Interventions

Foley balloon catheter DEVICE

18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix

PGE2 with Foley balloon catheter

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (2)

Doga

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

RECRUITING

Zeynep Kamil Education and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• ahmet eser

  Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

  STUDY DIRECTOR

Central Study Contacts

ahmet eser

CONTACT

905067136880; hicoice@yahoo.com

and yavuz

CONTACT

905062224075; andyavuz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: November 16, 2018
• Study Start: April 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: January 1, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

TU (2)