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

Induction of Labour Clinical Trial

— FOLOUT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02932319
• Other study ID #: 2015_10
• Secondary ID: 2015-A01298-41PH
• Status: Terminated
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: October 23, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labour
• Pregnancy, Prolonged
• Prolonged Pregnancy

Intervention

Device:
• Foley catheter
The Foley cathter will be inserted at term + 4 days for 24 hours.

Other:
• expectative
expectative until the next day befor starting the induction

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bishop score	Measure the evolution of Bishop score,change between the randomization and the return of the patient	at term birth +5 days
Secondary	Labour ward		at term birth +5 days
Secondary	Total dose of prostaglandin used in case of cervical ripening.		During labor
Secondary	Utilization rate of oxytocin		During labor
Secondary	Total dose of Ocytocin used or not for induction labor		During labor
Secondary	number of birth		between the term consultation + 4 days (randomization) and delivery time
Secondary	delivery rate		within 24 hours and 48 hours after randomization
Secondary	Caesarean rate		before labor and during labor
Secondary	Maternal complications	It's the time between the term consultation + 4 days (randomization) and delivery time (day 4)	through study completion, at 4 day
Secondary	Fetal complications		through study completion, at 4 day
Secondary	Neonatal complications		through study completion, at 4 day
Secondary	Duration of hospital stay		through study completion, at 4 day