Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

Study Overview
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Brief Summary
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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.

Official Title
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Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial

Conditions
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Prolonged Pregnancy

Intervention / Treatment
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* Device: Mechanical cervical ripening
* Drug: Pharmacological cervical ripening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women ≥ 18 years old With a singleton cephalic pregnancy between ≥41+0 weeks and ≤ 42+0 weeks of gestation Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) With a decision of induction of labour Written informed consent obtained from subject Subject covered by or having the rights to the French Social Security system 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 : Severe maternal hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) Renal failure with oliguria (< 500 ml/24h) or creatinine > 135μmol/L, or proteinuria > 5 g/day Pulmonary oedema, epigastric pain or HELLP syndrom (hemolysis, elevated liver enzyme, low platelets) Eclampsia or neurologic persisting symptoms (visual disturbances, headache, increased reflexes) Thrombopenia < 100 G/L 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical cervical ripening<br>mechanical cervical ripening with a Cook® Cervical Ripening Balloon | Device: Mechanical cervical ripening<br>* 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<br>|
| Active Comparator: Pharmacological cervical ripening<br>pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®) | Drug: Pharmacological cervical ripening<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged pregnancy, mechanical cervical ripening