Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-03-08 @ 4:11 AM
Study NCT ID:
NCT00641550
Status:
UNKNOWN
Last Update Posted:
2011-12-13
First Post:
2008-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Pregnancy: Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008124', 'term': 'Locomotion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-12', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-17', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit', 'timeFrame': 'nine months'}], 'secondaryOutcomes': [{'measure': 'Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical exercise', 'maternal complications', 'preterm labor', 'birthweight', 'Apgar scores'], 'conditions': ['Preeclampsia', 'Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '22825089', 'type': 'DERIVED', 'citation': 'de Oliveria Melo AS, Silva JL, Tavares JS, Barros VO, Leite DF, Amorim MM. Effect of a physical exercise program during pregnancy on uteroplacental and fetal blood flow and fetal growth: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):302-10. doi: 10.1097/AOG.0b013e31825de592.'}]}, 'descriptionModule': {'briefSummary': 'The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.', 'detailedDescription': 'The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group.\n\nThe objectives are:\n\n1. To describe and compare biological and obstetrical variables.\n2. To study doppler flow velocimetry indexes.\n3. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.\n4. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age \\< 13 weeks\n* Single pregnancy\n* Alive fetus\n* No previous practice of physical activity\n\nExclusion Criteria:\n\n* Smoking\n* Chronic maternal diseases\n* Placenta praevia\n* History of preterm labor\n* Bleeding'}, 'identificationModule': {'nctId': 'NCT00641550', 'briefTitle': 'Exercise and Pregnancy: Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual da Paraiba'}, 'officialTitle': 'Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'EXERC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)', 'interventionNames': ['Other: Physical exercise']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Pregnant women starting exercise at 20 weeks', 'interventionNames': ['Other: Physical exercise']}, {'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Pregnant women without exercise practice.'}], 'interventions': [{'name': 'Physical exercise', 'type': 'OTHER', 'otherNames': ['physical activity; physical exercise; walking'], 'description': 'Walking 3 times a week during 1 hours (moderate activity)', 'armGroupLabels': ['2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58100-000', 'city': 'Campina Grande', 'state': 'Paraíba', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Adriana Melo, MSc', 'role': 'CONTACT', 'email': 'asomelo@gmail.com', 'phone': '55-83-99732726'}, {'name': 'Melania Amorim, PhD', 'role': 'CONTACT', 'email': 'melamorim@uol.com.br', 'phone': '55-83-88221514'}, {'name': 'Adriana Melo, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidade Estadual da Paraiba', 'geoPoint': {'lat': -7.23056, 'lon': -35.88111}}, {'zip': '58100-000', 'city': 'Campina Grande', 'state': 'Paraíba', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Adriana Melo, MSc', 'role': 'CONTACT', 'email': 'asomelo@gmail.com', 'phone': '55-83-99732726'}, {'name': 'Melania Amorim, PhD', 'role': 'CONTACT', 'email': 'melamorim@uol.com.br', 'phone': '55-83-88221514'}, {'name': 'Adriana Melo, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidade Estadual da Paraíba', 'geoPoint': {'lat': -7.23056, 'lon': -35.88111}}], 'centralContacts': [{'name': 'Adriana Melo, MSc', 'role': 'CONTACT', 'email': 'asomelo@gmail.com', 'phone': '55-83-99732726'}, {'name': 'Melania Amorim, PhD', 'role': 'CONTACT', 'email': 'melamorim@uol.com.br', 'phone': '55-83-88221514'}], 'overallOfficials': [{'name': 'Melania Amorim, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Materno Infantil Prof. Fernando Figueira'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual da Paraiba', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Campinas, Brazil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Adriana Suely de Oliveira Melo', 'investigatorAffiliation': 'Universidade Estadual da Paraiba'}}}}