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Dinoprostone Induction vs. Expectant Management After PROM at Term

NCT05430711 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-06-24

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-06-30
Completion
2023-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430711 on ClinicalTrials.gov