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A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.
A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.
Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.
At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical cervical ripening | Experimental | mechanical cervical ripening with a Cook® Cervical Ripening Balloon |
|
| Pharmacological cervical ripening | Active Comparator | pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical cervical ripening | Device | The mechanical cervical ripening is a double transcervical balloon. The device used in the study is the Cook® Cervical Ripening Balloon with CE marked (commercialized by the Cook® laboratory, ref JCRBS-184000). It is a silicone double balloon catheter. Maximum balloon inflation is 80 mL/balloon. It will be used in accordance with user manual |
| Measure | Description | Time Frame |
|---|---|---|
| Caesarean section rate for non-reassuring fetal status. | Indication of the caesarean section will be settled by an adjudication committee at the end of the study | Up to 2 days after cervical ripening |
| Measure | Description | Time Frame |
|---|---|---|
| Time between cervical ripening and delivery in hours | Evaluation of time between cervical ripening and delivery in hours | Up to 2 days after cervical ripening |
| Delivery rate after 12 and 24 hours of cervical ripening |
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Inclusion Criteria:
Exclusion Criteria:
Bishop score ≥ 6 (favourable cervix)
Non cephalic presentation (breech, transverse)
Severe preeclampsia defined as the presence of preeclampsia with at least one of the following items :
Prior caesarean section or uterine scar
Placenta praevia
Suspected genital herpes infection
Known VIH seropositivity (confirmed by blood serology)
Premature rupture of membranes (PROM - continual leaking of amniotic fluid or positive test in favour of PROM)
Foetus with suspected severe congenital abnormalities
Pathological fetal heart rate
Contra-indications to Propess®
Contra-indications for using Cook® Cervical Ripening Balloon
Women under guardianship or trusteeship
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Brest | Brest | France | ||||
| CHU CAEN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33571294 | Result | Diguisto C, Le Gouge A, Arthuis C, Winer N, Parant O, Poncelet C, Chauleur C, Hannigsberg J, Ducarme G, Gallot D, Gabriel R, Desbriere R, Beucher G, Faraguet C, Isly H, Rozenberg P, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial. PLoS Med. 2021 Feb 11;18(2):e1003448. doi: 10.1371/journal.pmed.1003448. eCollection 2021 Feb. | |
| 36996264 |
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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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|
| Pharmacological cervical ripening | Drug | The comparative pharmacological procedure is a vaginal slow releasing system of dinoprostone. The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2). It will be used in accordance with Summary of Product Characteristics |
|
Evaluation of delivery rate after 12 and 24 hours of cervical ripening
| up to 2 days after cervical ripening |
| Induction with oxytocin | yes/no | up to 2 days after cervical ripening |
| Total dose of oxytocin required for induction of labour | evaluation of total dose of oxytocin required for induction of labour | up to 2 days after cervical ripening |
| Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period | uterine hyperstimulation | up to 2 days after cervical ripening |
| Requirement for tocolysis during cervical ripening or during labour | requirement for tocolysis | up to 2 days after cervical ripening |
| Suspicious or pathological fetal heart rate | FIGO classification | up to 2 days after cervical ripening |
| Uterine rupture | yes/no | up to 2 days after cervical ripening |
| Use of analgesics during labour | yes/no | up to 2 days after cervical ripening |
| Use of antibiotics during labour | yes/no | up to 2 days after cervical ripening |
| Indication for caesarean delivery other than non-reassuring FHR | (failure to progress in first or second stage of labour or maternal indication) | up to 2 days after cervical ripening |
| Type of vaginal delivery | spontaneous or instrumental, indication for instrumental delivery | up to 2 days after cervical ripening |
| Maternal intra partum infection | Suspicion of maternal intra partum infection | up to 2 days after cervical ripening |
| Maternal post partum infection | Suspicion of post partum infection | up to 2 days after cervical ripening |
| Maternal post partum haemorrhage | Post partum haemorrhage defined as estimated blood loss > 500 cc | up to 2 days after cervical ripening |
| Maternal blood transfusion | Blood transfusion | up to 2 days after cervical ripening |
| Neonatal apgar score | Apgar score at 1, 3, 5 and 10 minutes | at 1, 3, 5 and 10 minutes after delivery |
| Neonatal arterial ph | Arterial pH at delivery | at delivery |
| Intensive care unit for newborn | Admission in an intensive care unit | up to 5 days after cervical ripening |
| Neonatal respiratory insufficiency | Respiratory insufficiency with necessity of any respiratory support | up to 5 days after cervical ripening |
| Birth asphyxia | Birth asphyxia defined as pH<7, Base Excess >12 mmol/l and encephalopathy. | up to 5 days after cervical ripening |
| Caen |
| 14033 |
| France |
| Ch Pontoise | Cergy-Pontoise | 95303 | France |
| Ch Chartres | Chartres | France |
| Chu Clermont-Ferrand | Clermont-Ferrand | 63001 | France |
| Ch Departemental Vendee | La Roche-sur-Yon | 85925 | France |
| Hopital Saint Joseph | Marseille | 13008 | France |
| Chu Nantes | Nantes | 44093 | France |
| Chi Poissy | Poissy | France |
| Chu Reims | Reims | 51092 | France |
| Chu Rennes | Rennes | France |
| Chu Saint Etienne | Saint-Priest-en-Jarez | 42270 | France |
| Chu Toulouse | Toulouse | France |
| Chru Tours | Tours | 37044 | France |
| 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. |
| 28912192 | Derived | Diguisto C, Le Gouge A, Giraudeau B, Perrotin F. Mechanical cervicAl ripeninG for women with PrOlongedPregnancies (MAGPOP): protocol for a randomised controlled trial of a silicone double balloon catheter versus the Propess system for the slow release of dinoprostone for cervical ripening of prolonged pregnancies. BMJ Open. 2017 Sep 14;7(9):e016069. doi: 10.1136/bmjopen-2017-016069. |