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

NCT ID: NCT00545194

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to compare two different preparation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Ripening Labor, Induced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

sustained release preparation of prostaglandin E2

Group Type ACTIVE_COMPARATOR

Prostaglandin E2

Intervention Type DRUG

B

short-acting (instant-released) preparation of prostaglandin E2

Group Type ACTIVE_COMPARATOR

Prostaglandin E2

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prostaglandin E2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Franck Perrotin, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Tours Universiity Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Olympe de Gouges Women Health Centre, Bretonneau University Hospital

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Lyrenas S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. doi: 10.1111/j.1471-0528.2001.00039.x.

Reference Type BACKGROUND
PMID: 11236117 (View on PubMed)

Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. doi: 10.1080/00016340500523685.

Reference Type BACKGROUND
PMID: 16553177 (View on PubMed)

El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. doi: 10.1080/01443610600903362.

Reference Type BACKGROUND
PMID: 17071427 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROPESS Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prostin and Propess in Induction of Labor
NCT01635439 COMPLETED PHASE3
Vaginal Progesterone in Twins With Short Cervix
NCT01812239 WITHDRAWN PHASE2/PHASE3