Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
FOLOUT
3 other identifiers
interventional
43
1 country
5
Brief Summary
15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
5 active sites
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
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedStudy Start
First participant enrolled
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2019
CompletedApril 29, 2026
April 1, 2026
2.6 years
October 4, 2016
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bishop score
Measure the evolution of Bishop score,change between the randomization and the return of the patient
at term birth +5 days
Secondary Outcomes (11)
Labour ward
at term birth +5 days
Total dose of prostaglandin used in case of cervical ripening.
During labor
Utilization rate of oxytocin
During labor
Total dose of Ocytocin used or not for induction labor
During labor
number of birth
between the term consultation + 4 days (randomization) and delivery time
- +6 more secondary outcomes
Study Arms (2)
Foley catheter
ACTIVE COMPARATORThe patient will have an induction at home after 60 mn of fetal heart rate monitoring.
Expectative
SHAM COMPARATORThe patient in this arm will have the actual care (expectative until the next day befor starting the induction)
Interventions
Eligibility Criteria
You may qualify if:
- prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop \< 6
You may not qualify if:
- medical history small for gestationnal age PROM Live alone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU de Caen
Caen, France
Hôpital Jeanne de Flandre - CHRU
Lille, France
CH Roubaix
Roubaix, France
CHU Rouen
Rouen, France
Ch Valenciennes
Valenciennes, France
Related Publications (1)
Garabedian C, Tillouche N, Drumez E, Labreuche J, Dreyfus M, Deruelle P. Outpatient balloon catheter versus expectant management for post-term labor induction in nulliparous women: A randomized trial. J Gynecol Obstet Hum Reprod. 2024 Nov;53(9):102822. doi: 10.1016/j.jogoh.2024.102822. Epub 2024 Jul 10.
PMID: 38997091RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Garabedian, MD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 13, 2016
Study Start
March 31, 2017
Primary Completion
October 23, 2019
Study Completion
October 23, 2019
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share