Dinoprostone Induction vs. Expectant Management After PROM at Term

NCT ID: NCT05430711

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-07-31

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.

Conditions

Prelabor Rupture of Membranes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dinoprostone

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

Group Type: EXPERIMENTAL

Dinoprostone

Intervention Type: DRUG

After randomization, participants will receive dinoprostone 10 mg vaginal delivery system which will remain in place up to 24 hours or until the labour begins. At the onset of labor or after 24h it will be removed and participant transferred to labour room for further standard procedures.

Expectant management

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dinoprostone

After randomization, participants will receive dinoprostone 10 mg vaginal delivery system which will remain in place up to 24 hours or until the labour begins. At the onset of labor or after 24h it will be removed and participant transferred to labour room for further standard procedures.

Intervention Type: DRUG

Other Intervention Names

Propess

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Polona Peclin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Polona Pečlin

Role: CONTACT

polona.peclin@kclj.si

0038615526162

Other Identifiers

0120-115/2019/13

Identifier Type: -

Identifier Source: org_study_id