Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-29 @ 11:57 PM
Study NCT ID:
NCT03348332
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect During Pregnancy and Intrapartum Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage of labor', 'timeFrame': 'At the moment of delivery', 'description': 'Duration stages of labor (min)'}], 'secondaryOutcomes': [{'measure': 'Maternal gestational weight gain', 'timeFrame': '40-42 weeks of gestation', 'description': 'Change from baseline in maternal gestational weight gain (g)'}, {'measure': 'Glucose state', 'timeFrame': '24-26 weeks of gestation', 'description': 'Maternal glucose state (O´Sullivan test)'}, {'measure': 'Blood pressure', 'timeFrame': '12, 20 and 34 weeks of gestation', 'description': 'Maternal blood pressure during pregnancy (mmHg)'}, {'measure': 'Gestational age', 'timeFrame': 'At the moment of delivery', 'description': 'Gestational age (weeks)'}, {'measure': 'Birth weight', 'timeFrame': 'At the moment of delivery', 'description': 'Newborn weight (g)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'intrapartum', 'aerobic exercise', 'resistance exercise', 'wellbeing'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.', 'detailedDescription': 'The aim of this randomized controlled trial was to evaluate the effect of combined exercise (aerobic and strength exercise) on maternal and newborn intrapartum variables.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines.\n* Being able to communicate in spanish\n* Giving birth at Hospital Universitario de Puerta de Hierro (Majadahonda); Hospital Universitario Severo Ochoa (Leganés).\n\nExclusion Criteria:\n\n* Multiparity\n* Obstetrician complications\n* Being interested in the study after 18 weeks\n* Not being regular in physical exercise program\n* Younger than 18 years old'}, 'identificationModule': {'nctId': 'NCT03348332', 'briefTitle': 'Effect During Pregnancy and Intrapartum Health', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Madrid'}, 'officialTitle': 'Effect of Supervised Exercise During Pregnancy on Maternal and Newborn Intrapartum Health', 'orgStudyIdInfo': {'id': 'Intrapartum assessment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Sedentary pregnant women', 'description': 'Pregnant women who do not exercise regularly during pregnancy'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise pregnant women', 'description': 'Pregnant women who participate in a supervised exercise program', 'interventionNames': ['Behavioral: Exercise pregnant women']}], 'interventions': [{'name': 'Exercise pregnant women', 'type': 'BEHAVIORAL', 'description': 'A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor during the training sessions to control the intensity.', 'armGroupLabels': ['Exercise pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Politécnica de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Ruben Barakat Carballo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Politecnica de Madrid'}, {'name': 'María Perales Santaella, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Politecnica de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'María Perales Santaella', 'investigatorAffiliation': 'Technical University of Madrid'}}}}