Induction of Labour, Prolonged Pregnancy
Conditions
Keywords
induction of labour, nulliparous, prolonged pregnancy, foley catheter, vaginal birth
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
Interventions
DEVICEFoley catheter
The Foley cathter will be inserted at term + 4 days for 24 hours.
OTHERexpectative
expectative until the next day befor starting the induction
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bishop score | at term birth +5 days | Measure the evolution of Bishop score,change between the randomization and the return of the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCharles Garabedian, MD
University Hospital, Lille
Outcome results
None listed