Prolonged Pregnancy Clinical Trial
Official title:
Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial
Verified date | September 2019 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1224 |
Est. completion date | December 12, 2018 |
Est. primary completion date | December 12, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Brest | Brest | |
France | CHU CAEN | Caen | |
France | Ch Pontoise | Cergy Pontoise | |
France | Ch Chartres | Chartres | |
France | Chu Clermont-Ferrand | Clermont-ferrand | |
France | Ch Departemental Vendee | La Roche Sur Yon | |
France | Hopital Saint Joseph | Marseille | |
France | Chu Nantes | Nantes | |
France | Chi Poissy | Poissy | |
France | Chu Reims | Reims | |
France | Chu Rennes | Rennes | |
France | Chu Saint Etienne | Saint-priest En Jarez | |
France | Chu Toulouse | Toulouse | |
France | Chru Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Induction with oxytocin | yes/no | up to 2 days after cervical ripening | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Requirement for tocolysis during cervical ripening or during labour | requirement for tocolysis | up to 2 days after cervical ripening | |
Secondary | Suspicious or pathological fetal heart rate | FIGO classification | up to 2 days after cervical ripening | |
Secondary | Uterine rupture | yes/no | up to 2 days after cervical ripening | |
Secondary | Use of analgesics during labour | yes/no | up to 2 days after cervical ripening | |
Secondary | Use of antibiotics during labour | yes/no | up to 2 days after cervical ripening | |
Secondary | 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 | |
Secondary | Type of vaginal delivery | spontaneous or instrumental, indication for instrumental delivery | up to 2 days after cervical ripening | |
Secondary | Maternal intra partum infection | Suspicion of maternal intra partum infection | up to 2 days after cervical ripening | |
Secondary | Maternal post partum infection | Suspicion of post partum infection | up to 2 days after cervical ripening | |
Secondary | Maternal post partum haemorrhage | Post partum haemorrhage defined as estimated blood loss > 500 cc | up to 2 days after cervical ripening | |
Secondary | Maternal blood transfusion | Blood transfusion | up to 2 days after cervical ripening | |
Secondary | Neonatal apgar score | Apgar score at 1, 3, 5 and 10 minutes | at 1, 3, 5 and 10 minutes after delivery | |
Secondary | Neonatal arterial ph | Arterial pH at delivery | at delivery | |
Secondary | Intensive care unit for newborn | Admission in an intensive care unit | up to 5 days after cervical ripening | |
Secondary | Neonatal respiratory insufficiency | Respiratory insufficiency with necessity of any respiratory support | up to 5 days after cervical ripening | |
Secondary | Birth asphyxia | Birth asphyxia defined as pH<7, Base Excess >12 mmol/l and encephalopathy. | up to 5 days after cervical ripening |
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