Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT02708602
Status:
UNKNOWN
Last Update Posted:
2016-03-17
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total labor process', 'timeFrame': 'up to about 24h', 'description': 'time from the regular uterus contractions until completed childbirth, assessed up to about 24h'}, {'measure': 'duration of the first stage', 'timeFrame': 'up to about 20h', 'description': 'time from the regular uterus contractions to full cervix dilation,assessed up to about 20h'}, {'measure': 'duration of the second stage', 'timeFrame': 'up to about 2h', 'description': 'time from full cervix dilation to the complete childbirth, assessed up to about 2h'}, {'measure': 'Maternal visual analogue scale', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)', 'description': 'At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)'}], 'secondaryOutcomes': [{'measure': 'method of delivery', 'timeFrame': 'At time of placental delivery', 'description': 'At time of placental delivery'}, {'measure': 'Maternal modified Bromage scale', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)', 'description': 'At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)'}, {'measure': 'Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture', 'timeFrame': 'At two hours postpartum', 'description': 'At two hours postpartum'}, {'measure': 'Maternal satisfaction with analgesia', 'timeFrame': 'At two hours postpartum', 'description': 'At two hours postpartum'}, {'measure': 'Use of oxytocin after analgesia', 'timeFrame': 'At twenty-four hours postpartum', 'description': 'At twenty-four hours postpartum'}, {'measure': 'Neonatal Apgar scale', 'timeFrame': 'At the first and fifth minutes after baby was born', 'description': 'At the first and fifth minutes after baby was born'}, {'measure': 'Maximal oxytocin dose', 'timeFrame': 'At twenty-four hours postpartum', 'description': 'At twenty-four hours postpartum'}, {'measure': 'Maternal heart rate, respiratory rate, and blood pressure', 'timeFrame': 'At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)', 'description': 'At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)'}, {'measure': 'Neonatal weight', 'timeFrame': 'At delivery', 'description': 'At delivery'}]}, 'conditionsModule': {'keywords': ['β2-adrenergic receptor', 'genetic polymorphisms', 'labor progress'], 'conditions': ['Labor Analgesia']}, 'descriptionModule': {'briefSummary': 'Labor and delivery is a unique physiological experience of women. Inappropriate length of labor progress during vaginal delivery may produce great risks for mother and fetus. Especially the slow progress is one of the most important reasons for the occurrence of cesarean section during vaginal delivery, which still with a high incidence in recent years.Previous studies have found that there was a significant correlation between the genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship between the genetic polymorphisms and labor process after labor analgesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '23 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The parturient undergoing labor analgesia in our hospital. And the eligible parturient aged at 23-43, gestational age 35-42 weeks with an ASA grade I-II, who spontaneously choosing vaginal delivery mode with epidural analgesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous women\n* Required labor analgesia\n* Chinese\n* Spontaneous labor\n\nExclusion Criteria:\n\n* Contraindications for epidural analgesia\n* Allergic to opioids and/or local anesthetics\n* Failed to performing epidural catheterization\n* Organic dysfunction\n* Those who were not willing to or could not finish the whole study at any time\n* Using or used in the past 14 days of the monoamine oxidase inhibitors\n* Alcohol addictive or narcotic dependent patients\n* Subjects with a nonvertex presentation or scheduled induction of labor\n* Twin gestation and breech presentation'}, 'identificationModule': {'nctId': 'NCT02708602', 'briefTitle': 'Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Maternity and Child Health Care Hospital'}, 'officialTitle': 'Principal Investigator', 'orgStudyIdInfo': {'id': 'NMCHC2016003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'β2AR Arg16Arg (AA group)', 'description': 'People with β2AR Arg16Arg genotype.', 'interventionNames': ['Genetic: β2AR polymorphism']}, {'label': 'β2AR Arg16Gly (AG group)', 'description': 'People with β2AR Arg16Gly genotype.', 'interventionNames': ['Genetic: β2AR polymorphism']}, {'label': 'β2AR Gly16Gly (GG group)', 'description': 'People with β2AR Gly16Gly genotype.', 'interventionNames': ['Genetic: β2AR polymorphism']}, {'label': 'β2AR Gln27Gln (CC group)', 'description': 'People with β2AR Gln16Gln genotype.', 'interventionNames': ['Genetic: β2AR polymorphism']}, {'label': 'β2AR Gln27Glu (CG group)', 'description': 'People with β2AR Gln27Glu genotype.', 'interventionNames': ['Genetic: β2AR polymorphism']}, {'label': 'β2AR Glu27Glu (GG group)', 'description': 'People with β2AR Glu27Glu genotype.', 'interventionNames': ['Genetic: β2AR polymorphism']}], 'interventions': [{'name': 'β2AR polymorphism', 'type': 'GENETIC', 'armGroupLabels': ['β2AR Arg16Arg (AA group)', 'β2AR Arg16Gly (AG group)', 'β2AR Gln27Gln (CC group)', 'β2AR Gln27Glu (CG group)', 'β2AR Glu27Glu (GG group)', 'β2AR Gly16Gly (GG group)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Maternity and Child Health Care Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nanjing Maternity and Child Health Care Hospital', 'investigatorFullName': 'Caijuan Li', 'investigatorAffiliation': 'Nanjing Maternity and Child Health Care Hospital'}}}}