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Propess Versus Prostin for Induction of Labour in Women With Term PROM

NCT04743297 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2021-02-15

No results posted yet for this study

Summary

Premature rupture of membranes (PROM) at term is a rupture that occurs at term (\> 37 weeks) before the start of labor.

The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor in women with term PROM Propess (Controlled release dinoprostone, Vaginal Delivery System) and Prostin E2 (Dinoprostone vaginal Tablet).

Women will be randomised to two treatment groups.

Although some studies support efficacy of the Propess for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with PROM at term.

Conditions

  • Premature Rupture of Membranes at Term
  • Induction of Labour

Interventions

DRUG

Prostaglandin E2 (Propess)

Propess - The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour or at the occurrence of hyperstimulation.

DRUG

Prostaglandin E2 (Prostin)

Prostin - 3 mg vaginal tablet is placed in the posterior vaginal fornix. Dose can be repeated every 8 hours till onset of active labour or the occurrence of hyper-stimulation.

Sponsors & Collaborators

  • University Medical Centre Maribor

    lead OTHER

Principal Investigators

  • Veronika Anzeljc · Maribor University Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-01-31
Completion
2023-01-31

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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 NCT04743297 on ClinicalTrials.gov