Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

Prolonged Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907060
• Other study ID #: MAGPOP
• Status: Completed
• Phase: Phase 3
• Start date: January 27, 2017
• Est. completion date: December 12, 2018

Study information

• Verified date: September 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pregnancy, Prolonged
• Prolonged Pregnancy

Intervention

Device:
• Mechanical cervical ripening
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

Drug:
• Pharmacological cervical ripening
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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