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

February 9, 2021 updated by: University Medical Centre Maribor

Labour Induction With the Propess Vaginal Delivery System vs. Labour Induction With the Prostin Vaginal Tablet in Case of a Prelabour Rupture of Membranes. PESTIBOR Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is going to include all pregnant women with in-term PROM (after week 37 of pregnancy) without contractions if they meet the inclusion criteria. If the cervix is still non-inducible after 4-6 hours and there are no contractions, the medication to be administered to them will be determined by means of computer randomization. The success rate of induction with Propess vs. Prostin tablets will be compared. Soon after PROM, there can be the onset of contractions and cervix dilation that lead to childbirth.

In case of some pregnant women, there are no contractions and cervix dilation even after the event despite PROM and water breaking. If the status remains unchanged, the risk of intrauterine infection, fetus infection, and later on an infection of the newborn increases. The expecting mother can also eventually lose hope for a successful vaginal birth and starts thinking about having a caesarean delivery. To avoid that, the investigators use medications that accelerate the onset of vaginal birth in clinical practice.

The investigators know several ways to induce labour after PROM. References give no clear and reliable data on the best approach. The investigators can use medications such as oxytocin, dinoprostone, or misoprostol.

Our ward has been using Prostin 3 mg (dinoprostone) vaginal tablets to induce labour in case of PROM for several years. They have proven to be an efficient and safe procedure in our clinical practice.

Propess is used for the induction of labor with intact membranes. Based on the information from references and according to our experience, the medication is highly effective and safe, as well as easy to use.

Our study aims at establishing whether it can also be used with pregnant women with PROM.

Study Type

Interventional

Enrollment (Anticipated)

526

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 years or older
  • Gestational age 37 weeks or more
  • Singleton pregnancy
  • Cephalic presentation
  • Unfavorable cervix (BISHOP <6)
  • No contraindications for vaginal delivery
  • Without uterine surgery
  • Without chorioamnionitis

Exclusion Criteria:

  • Age less than 18 years
  • Multiple gestation
  • Previous cesarean section
  • Suspected intraamniotic infection
  • Any contraindication to vaginal delivery
  • Bishop score >7
  • Pathological ctg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propess Vaginal Delivery System
Propess - Prostaglandin E2 Vaginal Delivery System. Slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.
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.
Other Names:
  • dinoprostone
Active Comparator: Prostin Tablet
Prostaglandin E2 Vaginal Tablet 3 mg dinoprostone
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.
Other Names:
  • dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Induction to Delivery Interval
Time Frame: 24 hours
24 hours
Induction to Onset of labor Interval
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of Cesarean Sections
Time Frame: 24 hours
24 hours
Frequency of Failed Induction
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Maribor

Investigators

  • Study Chair: Veronika Anzeljc, Maribor University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRP-2020/01-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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