Clinical Trial: Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: University Hospital, Tours

Current Primary Outcome: Caesarean section rate for non-reassuring fetal status. [ Time Frame: 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


Original Primary Outcome: Caesarean section rate for non-reassuring fetal status. [ Time Frame: Up to 2 days after cervical ripening ]

Current Secondary Outcome:

  • Time between cervical ripening and delivery in hours [ Time Frame: Up to 2 days after cervical ripening ]
    Evaluation of time between cervical ripening and delivery in hours
  • Delivery rate after 12 and 24 hours of cervical ripening [ Time Frame: up to 2 days after cervical ripening ]
    Evaluation of delivery rate after 12 and 24 hours of cervical ripening
  • Induction with oxytocin [ Time Frame: up to 2 days after cervical ripening ]
    yes/no
  • Total dose of oxytocin required for induction of labour [ Time Frame: up to 2 days after cervical ripening ]
    evaluation of total dose of oxytocin required for induction of labour
  • Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period [ Time Frame: up to 2 days after cervical ripening ]
    uterine hyperstimulation
  • Requirement for tocolysis during cervical ripening or during labour [ Time Frame: up to 2 days after cervical ripening ]
    requirement for tocolysis
  • Suspicious or pathological fetal heart rate [ Time Frame: up to 2 days after cervical ripening ]
    FIGO classification
  • Uterine rupture [ Time Frame: up to 2 days after cervical ripening ]
    yes/no
  • Use of analgesics during labour [ Time Frame: up to 2 days after cervical ripening ]
    yes/no
  • Use of antibiotics during labour [ Time Frame: up to 2 days after cervical ripening ]
    yes/no
  • Indication for caesarean delivery other than non-reassuring FHR [ Time Frame: up to 2 days after cervical ripening ]
    (failure to progress in first or second stage of labour or maternal indication)
  • Type of vaginal delivery [ Time Frame: up to 2 days after cervical ripening ]
    spontaneous or instrumental, indication for instrumental delivery
  • Maternal intra partum infection [ Time Frame: up to 2 days after cervical ripening ]
    Suspicion of maternal intra partum infection
  • Maternal post partum infection [ Time Frame: up to 2 days after cervical ripening ]
    Suspicion of post partum infection
  • Maternal post partum haemorrhage [ Time Frame: up to 2 days after cervical ripening ]
    Post partum haemorrhage defined as estimated blood loss > 500 cc
  • Maternal blood transfusion [ Time Frame: up to 2 days after cervical ripening ]
    Blood transfusion
  • Neonatal apgar score [ Time Frame: at 1, 3, 5 and 10 minutes after delivery ]
    Apgar score at 1, 3, 5 and 10 minutes
  • Neonatal arterial ph [ Time Frame: at delivery ]
    Arterial pH at delivery
  • Intensive care unit for newborn [ Time Frame: up to 5 days after cervical ripening ]
    Admission in an intensive care unit
  • Neonatal respiratory insufficiency [ Time Frame: up to 5 days after cervical ripening ]
    Respiratory insufficiency with necessity of any respiratory support
  • Birth asphyxia [ Time Frame: up to 5 days after cervical ripening ]
    Birth asphyxia defined as pH<7, Base Excess >12 mmol/l and encephalopathy.


Original Secondary Outcome:

  • Time between cervical ripening and delivery in hours [ Time Frame: Up to 2 days after cervical ripening ]
  • Delivery rate after 12 and 24 hours of cervical ripening [ Time Frame: up to 2 days after cervical ripening ]
  • Induction with oxytocin [ Time Frame: up to 2 days after cervical ripening ]
    yes/no
  • Total dose of oxytocin required for induction of labour [ Time Frame: up to 2 days after cervical ripening ]
  • Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period [ Time Frame: up to 2 days after cervical ripening ]
  • Requirement for tocolysis during cervical ripening or during labour [ Time Frame: up to 2 days after cervical ripening ]
  • Suspicious or pathological fetal heart rate [ Time Frame: up to 2 days after cervical ripening ]
  • Uterine rupture [ Time Frame: up to 2 days after cervical ripening ]
  • Use of analgesics during labour [ Time Frame: up to 2 days after cervical ripening ]
  • Use of antibiotics during labour [ Time Frame: up to 2 days after cervical ripening ]
  • Indication for caesarean delivery other than non-reassuring FHR [ Time Frame: up to 2 days after cervical ripening ]
    (failure to progress in first or second stage of labour or maternal indication)
  • Type of vaginal delivery [ Time Frame: up to 2 days after cervical ripening ]
    spontaneous or instrumental, indication for instrumental delivery
  • Maternal intra partum infection [ Time Frame: up to 2 days after cervical ripening ]
    Suspicion of maternal intra partum infection
  • Maternal post partum infection [ Time Frame: up to 2 days after cervical ripening ]
    Suspicion of post partum infection
  • Maternal post partum haemorrhage [ Time Frame: up to 2 days after cervical ripening ]
    Post partum haemorrhage defined as estimated blood loss > 500 cc
  • Maternal blood transfusion [ Time Frame: up to 2 days after cervical ripening ]
    Blood transfusion
  • Neonatal apgar score [ Time Frame: at 1, 3, 5 and 10 minutes after delivery ]
    Apgar score at 1, 3, 5 and 10 minutes
  • Neonatal arterial ph [ Time Frame: at delivery ]
    Arterial pH at delivery
  • Intensive care unit for newborn [ Time Frame: up to 5 days after cervical ripening ]
    Admission in an intensive care unit
  • Neonatal respiratory insufficiency [ Time Frame: up to 5 days after cervical ripening ]
    Respiratory insufficiency with necessity of any respiratory support


Information By: University Hospital, Tours

Dates:
Date Received: September 6, 2016
Date Started: January 27, 2017
Date Completion: February 2020
Last Updated: February 23, 2017
Last Verified: February 2017