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

Not Applicable

Terminated

• Conditions: Induction of Labour; Prolonged Pregnancy
• Interventions: Device: Foley catheter; Other: expectative

• Registration Number: NCT02932319
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-13
• Study Start: 2017-03-31
• Primary Completion: 2019-10-23
• Study Completion: 2019-10-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley catheter	Foley catheter	The patient will have an induction at home after 60 mn of fetal heart rate monitoring.
Expectative	expectative	The patient in this arm will have the actual care (expectative until the next day befor starting the induction)

Primary Outcome Measures

Name	Time	Method
Bishop score	at term birth +5 days	Measure the evolution of Bishop score,change between the randomization and the return of the patient

Secondary Outcome Measures

Name	Time	Method
Fetal complications	through study completion, at 4 day
number of birth	between the term consultation + 4 days (randomization) and delivery time
Total dose of prostaglandin used in case of cervical ripening.	During labor
Total dose of Ocytocin used or not for induction labor	During labor
Labour ward	at term birth +5 days
Utilization rate of oxytocin	During labor
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)
Neonatal complications	through study completion, at 4 day
delivery rate	within 24 hours and 48 hours after randomization
Duration of hospital stay	through study completion, at 4 day

Trial Locations

Locations (5)

CHU de Caen; 🇫🇷 Caen, France

Hôpital Jeanne de Flandre - CHRU; 🇫🇷 Lille, France

Ch Valenciennes; 🇫🇷 Valenciennes, France

CHU Rouen; 🇫🇷 Rouen, France

CH Roubaix; 🇫🇷 Roubaix, France