Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

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

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.

Study Overview

• Status: Completed
• Conditions: Prolonged Pregnancy
• Intervention / Treatment: Device: Mechanical cervical ripening; Drug: Pharmacological cervical ripening

• Study Type: Interventional
• Enrollment (Actual): 1224
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Brest, France
    • CHU Brest
  • Caen, France, 14033
    • CHU Caen
  • Cergy Pontoise, France, 95303
    • CH Pontoise
  • Chartres, France
    • CH Chartres
  • Clermont-ferrand, France, 63001
    • CHU Clermont-Ferrand
  • La Roche Sur Yon, France, 85925
    • CH Départemental Vendée
  • Marseille, France, 13008
    • Hôpital Saint Joseph
  • Nantes, France, 44093
    • CHU Nantes
  • Poissy, France
    • CHI Poissy
  • Reims, France, 51092
    • CHU Reims
  • Rennes, France
    • CHU Rennes
  • Saint-priest En Jarez, France, 42270
    • CHU Saint Etienne
  • Toulouse, France
    • CHU Toulouse
  • Tours, France, 37044
    • CHRU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mechanical cervical ripening; mechanical cervical ripening with a Cook® Cervical Ripening Balloon	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
ACTIVE_COMPARATOR: Pharmacological cervical ripening; pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Induction with oxytocin	yes/no	up to 2 days after cervical ripening
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
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
Requirement for tocolysis during cervical ripening or during labour	requirement for tocolysis	up to 2 days after cervical ripening
Suspicious or pathological fetal heart rate	FIGO classification	up to 2 days after cervical ripening
Uterine rupture	yes/no	up to 2 days after cervical ripening
Use of analgesics during labour	yes/no	up to 2 days after cervical ripening
Use of antibiotics during labour	yes/no	up to 2 days after cervical ripening
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
Type of vaginal delivery	spontaneous or instrumental, indication for instrumental delivery	up to 2 days after cervical ripening
Maternal intra partum infection	Suspicion of maternal intra partum infection	up to 2 days after cervical ripening
Maternal post partum infection	Suspicion of post partum infection	up to 2 days after cervical ripening
Maternal post partum haemorrhage	Post partum haemorrhage defined as estimated blood loss > 500 cc	up to 2 days after cervical ripening
Maternal blood transfusion	Blood transfusion	up to 2 days after cervical ripening
Neonatal apgar score	Apgar score at 1, 3, 5 and 10 minutes	at 1, 3, 5 and 10 minutes after delivery
Neonatal arterial ph	Arterial pH at delivery	at delivery
Intensive care unit for newborn	Admission in an intensive care unit	up to 5 days after cervical ripening
Neonatal respiratory insufficiency	Respiratory insufficiency with necessity of any respiratory support	up to 5 days after cervical ripening
Birth asphyxia	Birth asphyxia defined as pH<7, Base Excess >12 mmol/l and encephalopathy.	up to 5 days after cervical ripening

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2017
• Primary Completion (ACTUAL): December 12, 2018
• Study Completion (ACTUAL): December 12, 2018

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (ESTIMATE): September 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: mechanical cervical ripening; prolonged pregnancy
• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Prolonged
• Other Study ID Numbers: MAGPOP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No