Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

NCT02907060 | Completed Phase 3

• 1 other identifier: MAGPOP
• Study Type: interventional
• Target: 1,224
• Locations: 1 country
• Sites: 14

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.

Conditions

Prolonged Pregnancy

Keywords

prolonged pregnancy; mechanical cervical ripening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• 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

  up to 2 days after cervical ripening

• Induction with oxytocin

  up to 2 days after cervical ripening

• 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

  up to 2 days after cervical ripening

Study Arms (2)

Mechanical cervical ripening

EXPERIMENTAL

mechanical cervical ripening with a Cook® Cervical Ripening Balloon

Device: Mechanical cervical ripening

Pharmacological cervical ripening

ACTIVE COMPARATOR

pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®)

Drug: Pharmacological cervical ripening

Interventions

Mechanical cervical ripening DEVICE

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

Mechanical cervical ripening

Pharmacological cervical ripening DRUG

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

Pharmacological cervical ripening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (14)

Chu Brest

Brest, France

Location

CHU CAEN

Caen, 14033, France

Location

Ch Pontoise

Cergy-Pontoise, 95303, France

Location

Ch Chartres

Chartres, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63001, France

Location

Ch Departemental Vendee

La Roche-sur-Yon, 85925, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Chu Nantes

Nantes, 44093, France

Location

Chi Poissy

Poissy, France

Location

Chu Reims

Reims, 51092, France

Location

Chu Rennes

Rennes, France

Location

Chu Saint Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Chu Toulouse

Toulouse, France

Location

Chru Tours

Tours, 37044, France

Location

Related Publications (3)

• 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.

  PMID: 33571294 RESULT

• 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.

  PMID: 36996264 DERIVED

• 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.

  PMID: 28912192 DERIVED

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 20, 2016
• Study Start: January 27, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (14)