Induction of Labor in Term Pregnancies With Unfavourable Cervix
NCT ID: NCT04280874
Last Updated: 2020-07-21
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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COMPLETED
PHASE4
212 participants
INTERVENTIONAL
2018-12-10
2020-07-01
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
SINGLE
Study Groups
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GROUP A
106 randomly selected pregnant women
Dinoprostone 0.5 MG
0.5mg dinoprostone applied intracervically
GROUP B
106 randomly selected pregnant women
Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
2mg dinoprostone applied intravaginally
Interventions
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Dinoprostone 0.5 MG
0.5mg dinoprostone applied intracervically
Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
2mg dinoprostone applied intravaginally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* unfavourable cervix (Bishop score \<6)
* indication for labor induction
* absence of uterine contractions
* reassuring cardiotocography
Exclusion Criteria
* scar uterus (previous caesarean section or uterus surgery)
* pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
FEMALE
Yes
Sponsors
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Clinical Hospital Merkur
OTHER
Responsible Party
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Katja Vince
Principal Investigator
Principal Investigators
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Katja Vince, MD
Role: STUDY_CHAIR
Clinical Hospital Merkur
Locations
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Clinical Hospital Merkur
Zagreb, , Croatia
Countries
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Other Identifiers
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RANDOM1
Identifier Type: -
Identifier Source: org_study_id
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