Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-07 @ 7:06 PM
Study NCT ID:
NCT02907060
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011273', 'term': 'Pregnancy, Prolonged'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caesarean section rate for non-reassuring fetal status.', 'timeFrame': 'Up to 2 days after cervical ripening', 'description': 'Indication of the caesarean section will be settled by an adjudication committee at the end of the study'}], 'secondaryOutcomes': [{'measure': 'Time between cervical ripening and delivery in hours', 'timeFrame': 'Up to 2 days after cervical ripening', 'description': 'Evaluation of time between cervical ripening and delivery in hours'}, {'measure': 'Delivery rate after 12 and 24 hours of cervical ripening', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'Evaluation of delivery rate after 12 and 24 hours of cervical ripening'}, {'measure': 'Induction with oxytocin', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'yes/no'}, {'measure': 'Total dose of oxytocin required for induction of labour', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'evaluation of total dose of oxytocin required for induction of labour'}, {'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', 'description': 'uterine hyperstimulation'}, {'measure': 'Requirement for tocolysis during cervical ripening or during labour', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'requirement for tocolysis'}, {'measure': 'Suspicious or pathological fetal heart rate', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'FIGO classification'}, {'measure': 'Uterine rupture', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'yes/no'}, {'measure': 'Use of analgesics during labour', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'yes/no'}, {'measure': 'Use of antibiotics during labour', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'yes/no'}, {'measure': 'Indication for caesarean delivery other than non-reassuring FHR', 'timeFrame': 'up to 2 days after cervical ripening', 'description': '(failure to progress in first or second stage of labour or maternal indication)'}, {'measure': 'Type of vaginal delivery', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'spontaneous or instrumental, indication for instrumental delivery'}, {'measure': 'Maternal intra partum infection', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'Suspicion of maternal intra partum infection'}, {'measure': 'Maternal post partum infection', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'Suspicion of post partum infection'}, {'measure': 'Maternal post partum haemorrhage', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'Post partum haemorrhage defined as estimated blood loss \\> 500 cc'}, {'measure': 'Maternal blood transfusion', 'timeFrame': 'up to 2 days after cervical ripening', 'description': 'Blood transfusion'}, {'measure': 'Neonatal apgar score', 'timeFrame': 'at 1, 3, 5 and 10 minutes after delivery', 'description': 'Apgar score at 1, 3, 5 and 10 minutes'}, {'measure': 'Neonatal arterial ph', 'timeFrame': 'at delivery', 'description': 'Arterial pH at delivery'}, {'measure': 'Intensive care unit for newborn', 'timeFrame': 'up to 5 days after cervical ripening', 'description': 'Admission in an intensive care unit'}, {'measure': 'Neonatal respiratory insufficiency', 'timeFrame': 'up to 5 days after cervical ripening', 'description': 'Respiratory insufficiency with necessity of any respiratory support'}, {'measure': 'Birth asphyxia', 'timeFrame': 'up to 5 days after cervical ripening', 'description': 'Birth asphyxia defined as pH\\<7, Base Excess \\>12 mmol/l and encephalopathy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prolonged pregnancy', 'mechanical cervical ripening'], 'conditions': ['Prolonged Pregnancy']}, 'referencesModule': {'references': [{'pmid': '33571294', 'type': 'RESULT', '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.'}, {'pmid': '36996264', 'type': 'DERIVED', 'citation': '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': '28912192', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nConsidering 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* ≥ 18 years old\n* With a singleton cephalic pregnancy between ≥41+0 weeks and ≤ 42+0 weeks of gestation\n* Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation)\n* With a decision of induction of labour\n* Written informed consent obtained from subject\n* Subject covered by or having the rights to the French Social Security system\n\nExclusion Criteria:\n\n* Bishop score ≥ 6 (favourable cervix)\n* Non cephalic presentation (breech, transverse)\n* Severe preeclampsia defined as the presence of preeclampsia with at least one of the following items :\n\n * Severe maternal hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg)\n * Renal failure with oliguria (\\< 500 ml/24h) or creatinine \\> 135μmol/L, or proteinuria \\> 5 g/day\n * Pulmonary oedema, epigastric pain or HELLP syndrom (hemolysis, elevated liver enzyme, low platelets)\n * Eclampsia or neurologic persisting symptoms (visual disturbances, headache, increased reflexes)\n * Thrombopenia \\< 100 G/L\n* Prior caesarean section or uterine scar\n* Placenta praevia\n* Suspected genital herpes infection\n* Known VIH seropositivity (confirmed by blood serology)\n* Premature rupture of membranes (PROM - continual leaking of amniotic fluid or positive test in favour of PROM)\n* Foetus with suspected severe congenital abnormalities\n* Pathological fetal heart rate\n* Contra-indications to Propess®\n* Contra-indications for using Cook® Cervical Ripening Balloon\n* Women under guardianship or trusteeship'}, 'identificationModule': {'nctId': 'NCT02907060', 'briefTitle': 'Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'MAGPOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical cervical ripening', 'description': 'mechanical cervical ripening with a Cook® Cervical Ripening Balloon', 'interventionNames': ['Device: Mechanical cervical ripening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacological cervical ripening', 'description': 'pharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®)', 'interventionNames': ['Drug: Pharmacological cervical ripening']}], 'interventions': [{'name': 'Mechanical cervical ripening', 'type': 'DEVICE', 'description': '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.\n\nIt will be used in accordance with user manual', 'armGroupLabels': ['Mechanical cervical ripening']}, {'name': 'Pharmacological cervical ripening', 'type': 'DRUG', 'description': '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).\n\nIt will be used in accordance with Summary of Product Characteristics', 'armGroupLabels': ['Pharmacological cervical ripening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'country': 'France', 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '95303', 'city': 'Cergy-Pontoise', 'country': 'France', 'facility': 'Ch Pontoise', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'city': 'Chartres', 'country': 'France', 'facility': 'Ch Chartres', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'zip': '63001', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Chu Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Ch Departemental Vendee', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '13008', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Chu Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Poissy', 'country': 'France', 'facility': 'Chi Poissy', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Chu Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Chru Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}