Dinoprostone Induction vs. Expectant Management After PROM at Term

NCT05430711 | Unknown Phase 4

• 1 other identifier: 0120-115/2019/13
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prelabor Rupture of Membranes

Keywords

Induction of labour; Dinoprostone; Cervical ripening

Outcome Measures

Primary Outcomes (1)

• Time from randomisation to delivery

  Time measured from randomisation to the delivery time

  Within 1 week

Secondary Outcomes (16)

• Time from randomisation to spontaneous vaginal delivery

  Within 1 week

• Time from PROM to delivery

  Within 1 week

• Cesarean delivery rate

  Within 1 week

• Instrumental delivery rate

  Within 1 week

• Use of oxytocin

  Within 1 week

Study Arms (2)

Dinoprostone

EXPERIMENTAL

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

Drug: Dinoprostone

Expectant management

NO INTERVENTION

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

Interventions

Dinoprostone 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.

Also known as: Propess

Dinoprostone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to12 hours after prelabour rupture of membranes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Dinoprostone

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Polona Pečlin

CONTACT

0038615526162; polona.peclin@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share