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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00811-52 | Other Identifier | 2017-A00811-52 |
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The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.
The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.
If the cervix is unfavourable (cervical Bishop's score <6), the information of the study is given to the patient and the consent collected.
An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.
After randomization, the patient is included in one of the two groups: Cook ® balloon or Propess ®.
After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook cervical ripening | Experimental | the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin |
|
| Dinoprostone vaginal group | Active Comparator | the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable. After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propess® (dinoprostone) | Drug | The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning. If the cervix is unfavourable (cervical Bishop's score <6), the information of the study is given to the patient and the consent collected. An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Time between the beginning of the induction of labor and the delivery | at day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time limits between the PROM and the beginning of induction | at day 1 | |
| Rate of delivery in the first 24 hours | at day 1 | |
| Application time of Cook® balloon |
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Inclusion Criteria:
Pregnant women
Unfavourable cervix (Bishop's score < 6) Agreement of the patient after clear, loyal and appropriate information Subject covered by or having the rights to the French Social Security system
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Denis GALLOT | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
| 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. | |
| 31227530 | Derived | Devillard E, Delabaere A, Rouzaire M, Pereira B, Accoceberry M, Houlle C, Dejou-Bouillet L, Bouchet P, Gallot D. Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments. BMJ Open. 2019 Jun 20;9(6):e026090. doi: 10.1136/bmjopen-2018-026090. |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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|
| cook cervical pipening balloon | Device | • In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable. |
|
| at day 1 |
| Application time of Propess® | at day 1 |
| Time between labour induction and vaginal delivery | at day 1 |
| Rate of vaginal delivery with and without extraction | at day 1 |
| Rate of cesarean | at day 1 |
| Rate of delivery hemorrhage | at day 1 |
| Bischop score when Cook balloon is fallen or retry | at day 1 |
| Rate of balloon present after 12 hours | at day 1 |
| Rate of anomaly of fetal heart rate leading stop of dinoprostone | at day 1 |
| Rate of epidural analgesia | at day 1 |
| Time to obtain active labour | at day 1 |
| Time to obtain complete cervix dilatation | at day 1 |
| Rate of fever during the labour | at day 1 |
| Rate of uterine hyperkinesias | at day 1 |
| Rate of clinic chorio-amnionitis defined by Newton criteria | at day 1 |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |