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Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.
Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.
But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).
The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).
The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin | Experimental |
| |
| balloon catheter | Experimental | Dufour 1859H18 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug |
| ||
| balloon catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of childbirth by low way | The childbirth by low way being considered as a success of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of incidence of materno-fœtales morbidity | number |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Gynécologie Obstétrique | Angoulême | France | ||||
| Service Gynécologie Obstétrique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Bressuire |
| France |
| Service Gynécologie Obstétrique | Châtellerault | France |
| Service Gynécologie Obstétrique | Nancy | France |
| Service Gynécologie Obstétrique et médecine de la reproduction | Poitiers | 86021 | France |
| Service Gynécologie Obstétrique | Rennes | France |
| Service Gynécologie Obstétrique | Toulouse | France |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |