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

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

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

Conditions
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Induction of Labour, Prolonged Pregnancy

Intervention / Treatment
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* Device: Foley catheter
* Other: expectative


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foley catheter<br>The patient will have an induction at home after 60 mn of fetal heart rate monitoring. | Device: Foley catheter<br>* The Foley cathter will be inserted at term + 4 days for 24 hours.<br>|
| Sham Comparator: Expectative<br>The patient in this arm will have the actual care (expectative until the next day befor starting the induction) | Other: expectative<br>* expectative until the next day befor starting the induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score | Measure the evolution of Bishop score,change between the randomization and the return of the patient | at term birth +5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | It's the time between the term consultation + 4 days (randomization) and delivery time (day 4) | through study completion, at 4 day | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labour, nulliparous, prolonged pregnancy, foley catheter, vaginal birth