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

Not Applicable

Terminated

• Conditions: Induction of Labour; Prolonged Pregnancy

• 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

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
Labour ward	at term birth +5 days
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
Total dose of Ocytocin used or not for induction labor	During labor
Utilization rate of oxytocin	During labor

Trial Locations

Locations (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