Dinoprostone Induction vs. Expectant Management After PROM at Term

University Medical Centre Ljubljana

Status and phase: Not yet enrolling; Phase 4

Conditions: Prelabor Rupture of Membranes

Treatments: Drug: Dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT05430711

0120-115/2019/13

Details and patient eligibility

About

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.

Full 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 Bishop score. When Bishop score at presentation will be ≤5, the study will be presented to the patient. Once the patient will be consented and randomized, women will receive dinoprostone vaginal delivery system (for up to 24 hours after randomisation) or will be managed expectantly (for up to 24 hours after randomisation).

Patients randomized to the expectant management group will be admitted to the maternity ward, where they will wait up to a maximum of 24 hours for labor to start spontaneously.

Patients in the induction group will also be admitted to the maternity ward and induced with a dinoprostone vaginal delivery system. If not removed sooner, the vaginal delivery system will be removed after 24h.

If patients in both groups will not be in active labor 24 hours after randomisation they will be admitted to the delivery room and health care providers will manage active labor per usual practice. The need for cesarean section or operative delivery or will be at the discretion of the healthcare provider.

In the days following birth, woman in both groups, will be asked to fill in a questionnaire about their satisfaction with the labour experience.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Dinoprostone

Experimental group

Description:

Participants will receive dinoprostone 10 mg vaginal delivery system for up to 24 hours.

Treatment:

Drug: Dinoprostone

Expectant management

No Intervention group

Description:

Participants will not receive drugs to induce labour, they will be managed expectantly for up to 24 hours.