Status:
UNKNOWN
Dinoprostone Induction vs. Expectant Management After PROM at Term
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Prelabor Rupture of Membranes
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
Prelabour rupture of membranes (PROM) is associated with intrauterine infection and maternal and neonatal consequences. This risk increases with the length of time from PROM to delivery. Induction of ...
Detailed Description
Women with singleton pregnancy in cephalic presentation at term (37-41 6/7 weeks gestational age) will be randomised 4 to 12 hours after PROM when a sterile vaginal exam will be completed to assign Bi...
Eligibility Criteria
Inclusion
- 4 to12 hours after prelabour rupture of membranes
- 18-50 years of age
- Parity 0 to 2
- Singleton pregnancy
- Cephalic presentation
- Term (37-41 6/7 weeks gestational age)
- Bishop score ≤5
- Reassuring fetal status
Exclusion
- Uterine contractions
- Signs of infection
- Signs of non-reassuring fetal status
- Meconium-stained amniotic fluid
- Group B Streptococcus colonization
- Fetal demise or major congenital anomaly
- Intrauterine growth restriction (estimated fetal weight ≤ 3 percentile)
- Contraindications for vaginal birth or use of prostaglandins for labor induction
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05430711
Start Date
June 1 2022
End Date
July 1 2023
Last Update
June 24 2022
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