Study Stopped
No participants enrolled
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The aim of this study is to compare two different preparation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2002
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedSeptember 4, 2025
October 1, 2007
2.8 years
October 16, 2007
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of vaginal deliveries within the 48 hours after cervical ripening
48 hours
Secondary Outcomes (10)
Proportion of total vaginal deliveries
48 hours
Vaginal deliveries at 12 hours, 24 hours and 36 hours
48 hours
Number of hyperkinesia with or without fetal heart rate monitoring abnormalities
48 hours
Number of hypertonia with or without fetal heart rate monitoring abnormalities
48 hours
Apgar score at 5 min less or equal 7
48 hours
- +5 more secondary outcomes
Study Arms (2)
A
ACTIVE COMPARATORsustained release preparation of prostaglandin E2
B
ACTIVE COMPARATORshort-acting (instant-released) preparation of prostaglandin E2
Interventions
Eligibility Criteria
You may qualify if:
- singleton pregnancy
- cephalic presentation
- gestation of more than 37 Weeks confirmed by ultrasound
- Bishop score less than 7
- Informed consent
You may not qualify if:
- previous cesarean section (scarred uterus)
- polyhydramnios
- multiple pregnancy
- fetal malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, 37044, France
Related Publications (3)
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.
PMID: 11236117BACKGROUNDStrobelt 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.
PMID: 16553177BACKGROUNDEl-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.
PMID: 17071427BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franck Perrotin, MD-PhD
Tours Universiity Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
January 1, 2002
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
September 4, 2025
Record last verified: 2007-10