Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies
- Conditions
- Prolonged Pregnancy
- Interventions
- Device: Mechanical cervical ripeningDrug: Pharmacological cervical ripening
- Registration Number
- NCT02907060
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1224
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mechanical cervical ripening Mechanical cervical ripening mechanical cervical ripening with a Cook® Cervical Ripening Balloon Pharmacological cervical ripening Pharmacological cervical ripening pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®)
- Primary Outcome Measures
Name Time Method Caesarean section rate for non-reassuring fetal status. Up to 2 days after cervical ripening Indication of the caesarean section will be settled by an adjudication committee at the end of the study
- Secondary Outcome Measures
Name Time Method Neonatal arterial ph at delivery Arterial pH at delivery
Birth asphyxia up to 5 days after cervical ripening Birth asphyxia defined as pH\<7, Base Excess \>12 mmol/l and encephalopathy.
Delivery rate after 12 and 24 hours of cervical ripening up to 2 days after cervical ripening Evaluation of delivery rate after 12 and 24 hours of cervical ripening
Requirement for tocolysis during cervical ripening or during labour up to 2 days after cervical ripening requirement for tocolysis
Use of analgesics during labour up to 2 days after cervical ripening yes/no
Time between cervical ripening and delivery in hours Up to 2 days after cervical ripening Evaluation of time between cervical ripening and delivery in hours
Induction with oxytocin up to 2 days after cervical ripening yes/no
Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period up to 2 days after cervical ripening uterine hyperstimulation
Indication for caesarean delivery other than non-reassuring FHR up to 2 days after cervical ripening (failure to progress in first or second stage of labour or maternal indication)
Neonatal apgar score at 1, 3, 5 and 10 minutes after delivery Apgar score at 1, 3, 5 and 10 minutes
Total dose of oxytocin required for induction of labour up to 2 days after cervical ripening evaluation of total dose of oxytocin required for induction of labour
Suspicious or pathological fetal heart rate up to 2 days after cervical ripening FIGO classification
Type of vaginal delivery up to 2 days after cervical ripening spontaneous or instrumental, indication for instrumental delivery
Maternal intra partum infection up to 2 days after cervical ripening Suspicion of maternal intra partum infection
Maternal post partum haemorrhage up to 2 days after cervical ripening Post partum haemorrhage defined as estimated blood loss \> 500 cc
Maternal blood transfusion up to 2 days after cervical ripening Blood transfusion
Intensive care unit for newborn up to 5 days after cervical ripening Admission in an intensive care unit
Uterine rupture up to 2 days after cervical ripening yes/no
Use of antibiotics during labour up to 2 days after cervical ripening yes/no
Maternal post partum infection up to 2 days after cervical ripening Suspicion of post partum infection
Neonatal respiratory insufficiency up to 5 days after cervical ripening Respiratory insufficiency with necessity of any respiratory support
Trial Locations
- Locations (14)
Chu Brest
🇫🇷Brest, France
CHU CAEN
🇫🇷Caen, France
Ch Pontoise
🇫🇷Cergy Pontoise, France
Ch Chartres
🇫🇷Chartres, France
Chu Nantes
🇫🇷Nantes, France
Ch Departemental Vendee
🇫🇷La Roche Sur Yon, France
Chu Clermont-Ferrand
🇫🇷Clermont-ferrand, France
Hopital Saint Joseph
🇫🇷Marseille, France
Chi Poissy
🇫🇷Poissy, France
Chu Rennes
🇫🇷Rennes, France
Chu Reims
🇫🇷Reims, France
Chu Saint Etienne
🇫🇷Saint-priest En Jarez, France
Chu Toulouse
🇫🇷Toulouse, France
Chru Tours
🇫🇷Tours, France