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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01298-41 | Other Identifier | ID-RCB number, ANSM | |
| PHRCI_2014 | Other Identifier | PHRC number, DGOS |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley catheter | Active Comparator | The patient will have an induction at home after 60 mn of fetal heart rate monitoring. |
|
| Expectative | Sham Comparator | The patient in this arm will have the actual care (expectative until the next day befor starting the induction) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter | Device | The Foley cathter will be inserted at term + 4 days for 24 hours. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Garabedian, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Caen | France | ||||
| Hôpital Jeanne de Flandre - CHRU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38997091 | Result | Garabedian C, Tillouche N, Drumez E, Labreuche J, Dreyfus M, Deruelle P. Outpatient balloon catheter versus expectant management for post-term labor induction in nulliparous women: A randomized trial. J Gynecol Obstet Hum Reprod. 2024 Nov;53(9):102822. doi: 10.1016/j.jogoh.2024.102822. Epub 2024 Jul 10. |
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| expectative | Other | expectative until the next day befor starting the induction |
|
| 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 |
| Lille |
| France |
| CH Roubaix | Roubaix | France |
| CHU Rouen | Rouen | France |
| Ch Valenciennes | Valenciennes | France |