Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies
NCT ID: NCT02907060
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1224 participants
INTERVENTIONAL
2017-01-27
2018-12-12
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mechanical cervical ripening
mechanical cervical ripening with a Cook® Cervical Ripening Balloon
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
Pharmacological cervical ripening
pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®)
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Locations
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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, , France
Countries
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References
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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.
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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.
Other Identifiers
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MAGPOP
Identifier Type: -
Identifier Source: org_study_id