Induction of Labor Affected Fetus / Newborn Clinical Trial
— RANDOfficial title:
Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
Verified date | July 2020 |
Source | Clinical Hospital Merkur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.
Status | Completed |
Enrollment | 212 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - term pregnancies (> 37 weeks gestation) - unfavourable cervix (Bishop score <6) - indication for labor induction - absence of uterine contractions - reassuring cardiotocography Exclusion Criteria: - ruptured membranes - 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Clinical Hospital Merkur | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Merkur |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time period between beginning of labor induction to delivery | hours (difference of 4 hours or more is considered significant) | 5 days | |
Secondary | number of births within 24h of start of labor induction | N (%) | 7 days | |
Secondary | number of deliveries by caesarean section or instrumental deliveries | N (%) | 7 days | |
Secondary | number of uterus hyperstimulation | N (%) | 7 days |
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