Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess

October 16, 2007 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

The aim of this study is to compare two different preparation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Tours, France, 37044
        • Olympe de Gouges Women Health Centre, Bretonneau University Hospital

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancy
  • cephalic presentation
  • gestation of more than 37 Weeks confirmed by ultrasound
  • Bishop score less than 7
  • Informed consent

Exclusion Criteria:

  • previous cesarean section (scarred uterus)
  • polyhydramnios
  • multiple pregnancy
  • fetal malformation

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
sustained release preparation of prostaglandin E2
Drug: Prostaglandin E2
ACTIVE_COMPARATOR: B
short-acting (instant-released) preparation of prostaglandin E2
Drug: Prostaglandin E2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of vaginal deliveries within the 48 hours after cervical ripening
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of total vaginal deliveries
Time Frame: 48 hours
48 hours
Vaginal deliveries at 12 hours, 24 hours and 36 hours
Time Frame: 48 hours
48 hours
Number of hyperkinesia with or without fetal heart rate monitoring abnormalities
Time Frame: 48 hours
48 hours
Number of hypertonia with or without fetal heart rate monitoring abnormalities
Time Frame: 48 hours
48 hours
Apgar score at 5 min less or equal 7
Time Frame: 48 hours
48 hours
Apgar score at 10 min less or equal 7
Time Frame: 48 hours
48 hours
Arterial pH less or equal 7.20
Time Frame: 48 hours
48 hours
Arterial base excess more than 12
Time Frame: 48 hours
48 hours
Number of maternal post-partum haemorrhage
Time Frame: 48 hours
48 hours
Time to reach 3cm cervical dilatation
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Franck Perrotin, MD-PhD, Tours Universiity Hospital

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

January 1, 2002

Study Completion (ACTUAL)

October 1, 2004

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (ESTIMATE)

October 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2007

Last Update Submitted That Met QC Criteria

October 16, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPESS Study

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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