Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy

NCT02932319 — Not applicable, Completed, 43 participants, University Hospital, Lille

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Registry	NCT02932319, acronym FOLOUT
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	43 (Actual)
Sponsor	University Hospital, Lille (Other)
Conditions	Induction of Labour, Prolonged Pregnancy
Interventions	Foley catheter, expectative (Device, other)
Dates	start 2017-03-31, primary completion 2019-10-23, completion 2019-10-23, first posted 2016-10-13, last updated 2026-04-29
Locations	5 sites in France

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Foley catheter	Active comparator	Device: Foley catheter	The patient will have an induction at home after 60 mn of fetal heart rate monitoring.
Expectative	Sham comparator	Other: expectative	The patient in this arm will have the actual care (expectative until the next day befor starting the induction)

Foley catheter (Device): The Foley cathter will be inserted at term + 4 days for 24 hours.
expectative (Other): expectative until the next day befor starting the induction

+Outcome measures

Primary outcomes

Bishop score [at term birth +5 days]: Measure the evolution of Bishop score,change between the randomization and the return of the patient

Secondary outcomes

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]
delivery rate [within 24 hours and 48 hours after randomization]
Caesarean rate [before labor and during labor]
Maternal complications [through study completion, at 4 day]: It's the time between the term consultation + 4 days (randomization) and delivery time (day 4)
Fetal complications [through study completion, at 4 day]
Neonatal complications [through study completion, at 4 day]
Duration of hospital stay [through study completion, at 4 day]

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop < 6

Exclusion Criteria:

* medical history small for gestationnal age PROM Live alone

+Locations (5)

Facility	City	Country
CHU de Caen	Caen	France
Hôpital Jeanne de Flandre - CHRU	Lille	France
CH Roubaix	Roubaix	France
CHU Rouen	Rouen	France
Ch Valenciennes	Valenciennes	France

+Publications

Results publication: 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 38997091

+Investigators

Charles Garabedian, MD, Principal investigator, University Hospital, Lille