Induction of Labour Clinical Trial
— FOLOUTOfficial title:
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
Verified date | March 2020 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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 |
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