Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT03018860
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2017-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative to Intensive Management of the Active Phase of the Second Stage of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1701}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal morbidity composite measure', 'timeFrame': 'at childbirth', 'description': 'number of participant with acidosis arterial cord pH \\<7.15 and / or excess base\\> 10 mmol / L and / or lactate\\> 6 mmol / L and or an Apgar score at 5 minutes \\<7 and or severe neonatal trauma defined by fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure) and or an Apgar score at 5 minutes \\<7 and or severe neonatal trauma: fractures, brachial plexus, facial paralysis, cephalohematoma, intracerebral hematoma other (neonatal morbidity composite measure)'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery', 'timeFrame': 'at childbirth', 'description': 'spontaneous vaginal, instrumental vaginal delivery or cesarean section'}, {'measure': 'Immediate postpartum complications', 'timeFrame': '2 hours after delivery', 'description': 'Perineal lesions with involvement of the anal sphincter (3rd and 4th degree)'}, {'measure': 'Immediate postpartum complications', 'timeFrame': '2 hours after delivery', 'description': 'Episiotomy'}, {'measure': 'Immediate postpartum complications', 'timeFrame': '2 hours after delivery', 'description': 'Cervical and vaginal lesion'}, {'measure': 'Immediate postpartum complications', 'timeFrame': '2 hours after delivery', 'description': 'Severe postpartum hemorrhage (blood loss estimated\\> 1000 mL, using sulprostone, intrauterine bloating, transfusion, uterine artery embolization, vessel ligation, uterine upholstery, of hysterectomy)'}, {'measure': 'Immediate postpartum complications', 'timeFrame': '2 hours after delivery', 'description': 'Postpartum Hemorrhage (blood loss estimated\\> 500mLand \\< 1000mL)'}, {'measure': 'Women satisfaction assessed with the Labour Agentry scale', 'timeFrame': '2 hours after delivery'}, {'measure': 'Women satisfaction assessed with the ICIQ-UI Short Form', 'timeFrame': '6 months post partum'}, {'measure': 'Urinary and anal incontinence assessed with the Wexner Score', 'timeFrame': '6 months post partum'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Active second stage', 'Neonatal morbidity', 'Operative delivery', 'Labor'], 'conditions': ['Active Second Stage']}, 'referencesModule': {'references': [{'pmid': '35868416', 'type': 'BACKGROUND', 'citation': 'Le Ray C, Rozenberg P, Kayem G, Harvey T, Sibiude J, Doret M, Parant O, Fuchs F, Vardon D, Azria E, Senat MV, Ceccaldi PF, Seco A, Garabedian C, Chantry AA; Groupe de Recherche en Obstetrique et Gynecologie. Alternative to intensive management of the active phase of the second stage of labor: a multicenter randomized trial (Phase Active du Second STade trial) among nulliparous women with an epidural. Am J Obstet Gynecol. 2022 Oct;227(4):639.e1-639.e15. doi: 10.1016/j.ajog.2022.07.025. Epub 2022 Jul 19.'}, {'pmid': '18406074', 'type': 'BACKGROUND', 'citation': 'Le Ray C, Audibert F. [Duration of pushing in labor: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2008 Jun;37(4):325-8. doi: 10.1016/j.jgyn.2008.02.009. Epub 2008 Apr 10. French.'}, {'pmid': '11281466', 'type': 'BACKGROUND', 'citation': 'Nordstrom L, Achanna S, Naka K, Arulkumaran S. Fetal and maternal lactate increase during active second stage of labour. BJOG. 2001 Mar;108(3):263-8. doi: 10.1111/j.1471-0528.2001.00034.x.'}, {'pmid': '19788968', 'type': 'BACKGROUND', 'citation': 'Le Ray C, Audibert F, Goffinet F, Fraser W. When to stop pushing: effects of duration of second-stage expulsion efforts on maternal and neonatal outcomes in nulliparous women with epidural analgesia. Am J Obstet Gynecol. 2009 Oct;201(4):361.e1-7. doi: 10.1016/j.ajog.2009.08.002.'}, {'pmid': '15467567', 'type': 'BACKGROUND', 'citation': 'Cheng YW, Hopkins LM, Caughey AB. How long is too long: Does a prolonged second stage of labor in nulliparous women affect maternal and neonatal outcomes? Am J Obstet Gynecol. 2004 Sep;191(3):933-8. doi: 10.1016/j.ajog.2004.05.044.'}, {'pmid': '26555447', 'type': 'BACKGROUND', 'citation': 'Dionne MD, Deneux-Tharaux C, Dupont C, Basso O, Rudigoz RC, Bouvier-Colle MH, Le Ray C. Duration of Expulsive Efforts and Risk of Postpartum Hemorrhage in Nulliparous Women: A Population-Based Study. PLoS One. 2015 Nov 10;10(11):e0142171. doi: 10.1371/journal.pone.0142171. eCollection 2015.'}, {'pmid': '37499991', 'type': 'DERIVED', 'citation': 'Dupuis N, Pizzoferrato AC, Garabedian C, Rozenberg P, Kayem G, Harvey T, Mandelbrot L, Doret M, Fuchs F, Azria E, Senat MV, Ceccaldi PF, Seco A, Chantry A, Le Ray C; GROG (Groupe de Recherche en Obstetrique et Gynecologie). Moderate or intensive management of the active phase of second-stage labor and risk of urinary and anal incontinence: results of the PASST randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):528.e1-528.e17. doi: 10.1016/j.ajog.2023.07.034. Epub 2023 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'Active phase of the second stage of labor corresponds to period of maternal expulsive efforts (i.e. pushing). An intensive management of this phase is usual in France. This study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery.', 'detailedDescription': 'Management of the active phase of the second stage of labor is not an evidence-based practice. Management of this phase differs between countries. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.\n\nThis study aims to evaluate the impact of an alternative "moderate" management during this pushing phase on neonatal and maternal issues and mode of delivery. In the intervention group, i.e. "moderate" pushing, women are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.\n\nThe hypothesis is that "moderate" management of the active phase of the second stage allows decreasing frequency of neonatal morbidity at birth, decreasing frequency of operative delivery and increasing maternal satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* primiparous women\n* singleton fetus\n* fetal cephalic presentation\n* ≥37 gestational weeks\n* living fetus\n* Patient with epidural analgesia\n* Major Female\n* Women understand French\n\nExclusion Criteria :\n\n* Abnormal fetal heart rate requiring hastening childbirth\n* cervical dilatation \\< 8 cm\n* intrauterine fetal growth restriction \\<5e percentile,\n* Fetal malformation,\n* history of gynecological surgery with uterine scar\n* Women do not understand French,\n* women with psychiatric condition\n* contraindication to intensive management of active second stage (severe myopia, respiratory or cardiac failure)\n* no affiliation to a social security scheme (beneficiary or assignee)'}, 'identificationModule': {'nctId': 'NCT03018860', 'acronym': 'PASST', 'briefTitle': 'Alternative to Intensive Management of the Active Phase of the Second Stage of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Alternative to Intensive Management of the Active Phase of the Second Stage of Labor : a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P150937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Moderate" management', 'description': 'Women are encouraged by physicians to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.', 'interventionNames': ['Procedure: "Moderate" management']}, {'type': 'ACTIVE_COMPARATOR', 'label': '"Intensive" management', 'description': 'Usual obstetrical care in France', 'interventionNames': ['Procedure: "Intensive" management']}], 'interventions': [{'name': '"Moderate" management', 'type': 'PROCEDURE', 'description': 'After randomization, women allocated to the intervention group, i.e. "moderate" pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration.', 'armGroupLabels': ['"Moderate" management']}, {'name': '"Intensive" management', 'type': 'PROCEDURE', 'description': 'This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.', 'armGroupLabels': ['"Intensive" management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'paris', 'country': 'France', 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre-Yves ANCEL, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}