Dinoprostone Induction vs. Expectant Management After PROM at Term

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

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 labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined.

The main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing PROM at term-expectant management and induction with a dinoprostone vaginal delivery system.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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