Clinical trial NCT05430711: Dinoprostone Induction vs. Expectant Management After PROM at Term
Official title: Induction of Labour With Dinoprostone vs. Expectant Management After Prelabour Rupture of Membranes at Term
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prelabor Rupture of Membranes
Keywords: Induction of labour
Dinoprostone
Cervical ripening
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Time from randomisation to delivery
timeFrame: Within 1 week
Secondary outcomes:
measure: Time from randomisation to spontaneous vaginal delivery
timeFrame: Within 1 week
measure: Time from PROM to delivery
timeFrame: Within 1 week
measure: Cesarean delivery rate
timeFrame: Within 1 week
measure: Instrumental delivery rate
timeFrame: Within 1 week
measure: Use of oxytocin
timeFrame: Within 1 week
measure: Hyperstimulation with nonreassuring fetal heart rate tracing
timeFrame: Within 1 week
measure: Rate of chorioamnionitis
timeFrame: Within 1 week
measure: Rate of endometritis
timeFrame: Within 3 weeks
measure: Rate of postpartum maternal fever
timeFrame: Within 3 weeks
measure: Use of antibiotics
timeFrame: Within 3 weeks
measure: Lenght of antibiotic treatment
timeFrame: 3 weeks
measure: Number of neonates, admitted to intensive care unit
timeFrame: Within 3 weeks
measure: APGAR scores
timeFrame: Within 1 week
measure: Maternal Length of Stay
timeFrame: Within 3 weeks
measure: Rate of early neonatal sepsis
timeFrame: Within 3 weeks
measure: Patients perception of labor (length, pain, overall satisfaction)
timeFrame: Within 3 weeks
Other outcomes:
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