A Randomized Trial of Induction Methods in Premature Rupture of Membranes
NCT ID: NCT03744078
Last Updated: 2018-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-04-15
2019-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Foley balloon catheter
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
PGE2 vaginal ovule
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix
No interventions assigned to this group
Interventions
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Foley balloon catheter
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
Eligibility Criteria
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Inclusion Criteria
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
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 -
18 Years
40 Years
FEMALE
Yes
Sponsors
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Zeynep Kamil Maternity and Pediatric Research and Training Hospital
OTHER
Responsible Party
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Ahmet Eser
M.D.
Principal Investigators
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ahmet eser
Role: STUDY_DIRECTOR
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
Locations
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Doga
Istanbul, Kucukcekmece, Turkey (Türkiye)
Zeynep Kamil Education and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Doga Seckin
Role: backup
References
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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.
Other Identifiers
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47
Identifier Type: -
Identifier Source: org_study_id
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