Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy (FOLOUT)

University Hospital, Lille

Status: Terminated

Conditions: Prolonged Pregnancy; Induction of Labour

Treatments: Device: Foley catheter; Other: expectative

Study type: Interventional

Funder types: Other

Identifiers

NCT02932319

PHRCI_2014 (Other Identifier)

2015-A01298-41 (Other Identifier)

2015_10

Details and patient eligibility

About

15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Foley catheter

Active Comparator group

Description:

The patient will have an induction at home after 60 mn of fetal heart rate monitoring.

Treatment:

Device: Foley catheter

Expectative

Sham Comparator group

Description:

The patient in this arm will have the actual care (expectative until the next day befor starting the induction)

Treatment:

Other: expectative