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NCT03744078

A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Status unknown NA Last updated 16 November 2018
What this trial tests

NA trial testing Foley balloon catheter in Preterm Premature Rupture of Fetal Membranes in 200 participants. Status unknown.

Timeline
15 April 2018
Primary endpoint
15 December 2018
1 January 2019

Quick facts

Lead sponsorZeynep Kamil Maternity and Pediatric Research and Training Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date15 April 2018
Primary completion15 December 2018
Estimated completion1 January 2019
Sites2 locations across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Who can join

Adults 18 to 40, female only, with Preterm Premature Rupture of Fetal Membranes or Induction of Labor Affected Fetus / Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mechanical methods for induction of labour.
    de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, et al · · 2019 · cited 46× · PMID 31623014 · DOI 10.1002/14651858.cd001233.pub3
  2. Mechanical methods for induction of labour.
    de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, et al · · 2023 · cited 30× · PMID 36996264 · DOI 10.1002/14651858.cd001233.pub4

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Other Zeynep Kamil Maternity and Pediatric Research and Training Hospital trials

Trials by the same sponsor.

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