Clinical trial NCT02907060: Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies
Official title: Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prolonged Pregnancy
Keywords: prolonged pregnancy
mechanical cervical ripening
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 1224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Caesarean section rate for non-reassuring fetal status.
timeFrame: Up to 2 days after cervical ripening
Secondary outcomes:
measure: Time between cervical ripening and delivery in hours
timeFrame: Up to 2 days after cervical ripening
measure: Delivery rate after 12 and 24 hours of cervical ripening
timeFrame: up to 2 days after cervical ripening
measure: Induction with oxytocin
timeFrame: up to 2 days after cervical ripening
measure: Total dose of oxytocin required for induction of labour
timeFrame: up to 2 days after cervical ripening
measure: Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period
timeFrame: up to 2 days after cervical ripening
measure: Requirement for tocolysis during cervical ripening or during labour
timeFrame: up to 2 days after cervical ripening
measure: Suspicious or pathological fetal heart rate
timeFrame: up to 2 days after cervical ripening
measure: Uterine rupture
timeFrame: up to 2 days after cervical ripening
measure: Use of analgesics during labour
timeFrame: up to 2 days after cervical ripening
measure: Use of antibiotics during labour
timeFrame: up to 2 days after cervical ripening
measure: Indication for caesarean delivery other than non-reassuring FHR
timeFrame: up to 2 days after cervical ripening
measure: Type of vaginal delivery
timeFrame: up to 2 days after cervical ripening
measure: Maternal intra partum infection
timeFrame: up to 2 days after cervical ripening
measure: Maternal post partum infection
timeFrame: up to 2 days after cervical ripening
measure: Maternal post partum haemorrhage
timeFrame: up to 2 days after cervical ripening
measure: Maternal blood transfusion
timeFrame: up to 2 days after cervical ripening
measure: Neonatal apgar score
timeFrame: at 1, 3, 5 and 10 minutes after delivery
measure: Neonatal arterial ph
timeFrame: at delivery
measure: Intensive care unit for newborn
timeFrame: up to 5 days after cervical ripening
measure: Neonatal respiratory insufficiency
timeFrame: up to 5 days after cervical ripening
measure: Birth asphyxia
timeFrame: up to 5 days after cervical ripening
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
city: Caen
country: France
facility: CHU CAEN
city: Cergy Pontoise
country: France
facility: Ch Pontoise
city: Chartres
country: France
facility: Ch Chartres
city: Clermont-ferrand
country: France
facility: Chu Clermont-Ferrand
city: La Roche Sur Yon
country: France
facility: Ch Departemental Vendee
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Nantes
country: France
facility: Chu Nantes
city: Poissy
country: France
facility: Chi Poissy
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Chu Rennes
city: Saint-priest En Jarez
country: France
facility: Chu Saint Etienne
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: Chru Tours
Study officials:
References:
citation: Diguisto C, Le Gouge A, Arthuis C, Winer N, Parant O, Poncelet C, Chauleur C, Hannigsberg J, Ducarme G, Gallot D, Gabriel R, Desbriere R, Beucher G, Faraguet C, Isly H, Rozenberg P, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial. PLoS Med. 2021 Feb 11;18(2):e1003448. doi: 10.1371/journal.pmed.1003448. eCollection 2021 Feb.
citation: Diguisto C, Le Gouge A, Giraudeau B, Perrotin F. Mechanical cervicAl ripeninG for women with PrOlongedPregnancies (MAGPOP): protocol for a randomised controlled trial of a silicone double balloon catheter versus the Propess system for the slow release of dinoprostone for cervical ripening of prolonged pregnancies. BMJ Open. 2017 Sep 14;7(9):e016069. doi: 10.1136/bmjopen-2017-016069.