{"protocolSection":{"identificationModule":{"nctId":"NCT01409382","orgStudyIdInfo":{"id":"000416-09-08-2010"},"organization":{"fullName":"Hospital dos Servidores do Estado do Rio de Janeiro","class":"OTHER_GOV"},"briefTitle":"Maternal Lifestyle and Neonatal Hypoglycemia","officialTitle":"Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes"},"statusModule":{"statusVerifiedDate":"2016-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-03"},"primaryCompletionDateStruct":{"date":"2013-04","type":"ACTUAL"},"completionDateStruct":{"date":"2015-10","type":"ACTUAL"},"studyFirstSubmitDate":"2011-05-27","studyFirstSubmitQcDate":"2011-08-03","studyFirstPostDateStruct":{"date":"2011-08-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-04-26","resultsFirstSubmitQcDate":"2015-12-13","resultsFirstPostDateStruct":{"date":"2016-01-21","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-08-19","lastUpdatePostDateStruct":{"date":"2016-09-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Silvia Hoirisch Clapauch","investigatorTitle":"Principal investigator","investigatorAffiliation":"Hospital dos Servidores do Estado do Rio de Janeiro"},"leadSponsor":{"name":"Hospital dos Servidores do Estado do Rio de Janeiro","class":"OTHER_GOV"},"collaborators":[{"name":"Rio de Janeiro State Research Supporting Foundation (FAPERJ)","class":"OTHER_GOV"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane (directly or through activation of matrix metalloproteinases) and formation of hemidesmosomes.\n\nA high-carbohydrate intake combined with lack of physical activity provides a strong stimulus for maternal insulin production. In this scenario, either β-cells are dysfunctional and diabetes supervenes, or excessive amounts of insulin are produced, providing pathological stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor, PAI-1 excess may affect placentation, increasing the risk of first trimester losses, preterm deliveries and intrauterine growth restriction.\n\nOur hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of insulin.","detailedDescription":"In an observational study, we sought to determine whether markers of hyperinsulinemia or situations that increase maternal insulin requirements would increase the risk of neonatal hypoglycemia. Mothers were selected if they had grade III obesity, acanthosis nigricans (surrogates of chronic maternal hyperinsulinemia), any invasive bacterial infection or if they had used corticosteroid within seven days before delivery (surrogates of subacute insulin resistance), if they reported to have consumed a high-glycemic index diet within 24 hours before delivery or if they were physically inactive within 24 hours before delivery (conditions that could increase maternal insulin requirements close to delivery).\n\nBased on the finding that that the risk of neonatal hypoglycemia increased fivefold with inactivity (95% CI: 2-11, P \\<0.001), 11-fold with high-carbohydrate intake (95% CI: 4-24, P \\<0.001) and 329-fold with both risk factors (95% CI: 32-3362, P \\<0.001), next we have evaluated how a protocol combining exercises and a balanced diet throughout pregnancy influences maternal and neonatal outcomes. One of the outcomes analyzed was neonatal hypoglycemia."},"conditionsModule":{"conditions":["Hyperinsulinemia","Miscarriages","Pregnancy","Sedentary Lifestyle","Hypoglycemia"],"keywords":["neonatal hypoglycemia","pregnancy","physical activity","sedentary lifestyle","high-glycemic index diet","take-home baby","recurrent miscarriages","preterm delivery"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":480,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lifestyle counseling","type":"ACTIVE_COMPARATOR","description":"Daily brisk walking plus a carbohydrate-restricted diet","interventionNames":["Behavioral: Daily brisk walking plus a carbohydrate-restricted diet"]},{"label":"Standard follow-up","type":"NO_INTERVENTION","description":"Prenatal care will proceed according to the routine."}],"interventions":[{"type":"BEHAVIORAL","name":"Daily brisk walking plus a carbohydrate-restricted diet","description":"Daily brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7 days a week. Patients will be recommended to avoid high-glycemic index meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Recommendations will be emphasised at every appointment. Antidepressants will not be discontinued in both groups, but patients on paroxetine and sertraline, will be switched to fluoxetine.","armGroupLabels":["Lifestyle counseling"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Neonatal Hypoglycemia","description":"Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.","timeFrame":"1, 2 and 4 h after birth."}],"secondaryOutcomes":[{"measure":"Refractory Hypoglycemia","description":"Any glucose level ≤ 40/dL at 1, 2 or 4 h:\n\n1. Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.\n2. A new heel stick blood sample will be drawn to assess glucose levels.\n3. Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia.","timeFrame":"One hour after feeding or after intravenous dextrose"}],"otherOutcomes":[{"measure":"Pregnancy and Neonatal Outcomes","description":"Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies","timeFrame":"Three years"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria: recurrent early unexplained miscarriages Exclusion criteria: (i) antiphospholipid antibodies, (ii) second- or third-trimester losses, (iii) multiple pregnancy, (iv) anatomical abnormalities that could increase the risk of early miscarriages, (iv) any condition requiring a priori anticoagulation, (v) protocol violation.","healthyVolunteers":false,"sex":"ALL","maximumAge":"40 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Maria A Sayeg-Porto, MD, PhD","affiliation":"Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Paulo R Benchimol-Barbosa, MD, DSc","affiliation":"Universidade Gama Filho; COPPE/UFRJ","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Silvia Hoirisch-Clapauch, MD","affiliation":"Hospital dos Servidores do Estado, RJ","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Hospital Federal dos Servidores do Estado","city":"Rio de Janeiro","state":"Rio de Janeiro","zip":"20221-903","country":"Brazil","geoPoint":{"lat":-22.90642,"lon":-43.18223}}]},"referencesModule":{"references":[{"type":"RESULT","citation":"Hoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013."}]},"ipdSharingStatementModule":{"ipdSharing":"YES"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Recruitment has started in March 2011 at a High-Risk Maternal and Fetal Unit of a tertiary hospital. Enrollment started in May 2011.","groups":[{"id":"FG000","title":"Lifestyle Counseling","description":"Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine."},{"id":"FG001","title":"Standard Follow-up","description":"Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"240"},{"groupId":"FG001","numSubjects":"240"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"160"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"81"},{"groupId":"FG001","numSubjects":"80"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Multiple pregnancy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Still pregnant when study ended","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Did not manage to get pregnant","reasons":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"70"}]},{"type":"Had a 2nd trimester loss after accident","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Women with recurrent fetal losses in the first trimester","groups":[{"id":"BG000","title":"Lifestyle Counseling","description":"Daily brisk walking plus a carbohydrate-restricted diet"},{"id":"BG001","title":"Standard Follow-up","description":"Prenatal care will proceed according to the routine"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"240"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"480"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"240"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"480"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34","spread":"6"},{"groupId":"BG001","value":"33","spread":"8"},{"groupId":"BG002","value":"33","spread":"7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"240"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"480"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Brazil","categories":[{"measurements":[{"groupId":"BG000","value":"240"},{"groupId":"BG001","value":"240"},{"groupId":"BG002","value":"480"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Neonatal Hypoglycemia","description":"Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"neonates","timeFrame":"1, 2 and 4 h after birth.","typeUnitsAnalyzed":"blood samples 1, 2 and 4 h after birth","denomUnitsSelected":"Participants","groups":[{"id":"OG000","title":"Lifestyle Counseling","description":"Daily brisk walking plus a carbohydrate-restricted diet"},{"id":"OG001","title":"Standard Follow-up","description":"Prenatal care will proceed according to the routine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"91"}]},{"units":"blood samples 1, 2 and 4 h after birth","counts":[{"groupId":"OG000","value":"420"},{"groupId":"OG001","value":"273"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"15"}]}]}]},{"type":"SECONDARY","title":"Refractory Hypoglycemia","description":"Any glucose level ≤ 40/dL at 1, 2 or 4 h:\n\n1. Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.\n2. A new heel stick blood sample will be drawn to assess glucose levels.\n3. Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia.","populationDescription":"All hypoglycemic neonates were screened for refractory hypoglycemia. Only neonates born to mothers who were physically inactive and reported excessive carbohydrate consumption displayed refractory hypoglycemia.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"neonates with refractory hypoglycemia","timeFrame":"One hour after feeding or after intravenous dextrose","groups":[{"id":"OG000","title":"Neonates Born to Mothers Assigned to Protocol Walking+Diet","description":"Neonates with hypoglycemia (blood glucose levels ≤ 40 mg/dL) at 1, 2 or 4 hours after birth"},{"id":"OG001","title":"Neonates Born to Controls","description":"Neonates with hypoglycemia detected 1, 2 or 4 hours after birth"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Pregnancy and Neonatal Outcomes","description":"Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants (babies)","timeFrame":"Three years","groups":[{"id":"OG000","title":"Lifestyle Counseling","description":"Daily brisk walking plus a carbohydrate-restricted diet"},{"id":"OG001","title":"Standard Follow-up","description":"Prenatal care will proceed according to the routine."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"160"}]}],"classes":[{"title":"Early Miscarriages","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"62"}]}]},{"title":"Second and Third Trimester Losses","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"7"}]}]},{"title":"Live Born","categories":[{"measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"91"}]}]},{"title":"Term","categories":[{"measurements":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"57"}]}]},{"title":"Take-home babies","categories":[{"measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"83"}]}]},{"title":"Neonatal hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Take home babies","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.05","statisticalMethod":"Chi-squared","paramType":"Odds Ratio (OR)","paramValue":"3.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.5","ciUpperLimit":"7.6","dispersionType":"STANDARD_DEVIATION","dispersionValue":"1"}]}]},"adverseEventsModule":{"frequencyThreshold":"1","timeFrame":"From the first prenatal consultation until four hours after delivery. Intervention refers to the mother. The outcome refers to the baby or to the mother.","eventGroups":[{"id":"EG000","title":"Standard Follow-up (Mothers)","description":"Prenatal care will proceed according to the routine.","seriousNumAffected":36,"seriousNumAtRisk":160,"otherNumAffected":0,"otherNumAtRisk":160},{"id":"EG001","title":"Lifestyle Counseling (Mothers)","description":"Exercise plus a carbohydrate-controlled diet.","seriousNumAffected":10,"seriousNumAtRisk":159,"otherNumAffected":0,"otherNumAtRisk":159},{"id":"EG002","title":"Standard Follow-up (Babies)","description":"Prenatal care will proceed according to the routine.","seriousNumAffected":84,"seriousNumAtRisk":160,"otherNumAffected":0,"otherNumAtRisk":160},{"id":"EG003","title":"Lifestyle Counseling (Babies)","description":"Exercise plus a carbohydrate-controlled diet.","seriousNumAffected":22,"seriousNumAtRisk":159,"otherNumAffected":0,"otherNumAtRisk":159}],"seriousEvents":[{"term":"First trimester","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"early miscarriages","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":62,"numAtRisk":160},{"groupId":"EG003","numAffected":19,"numAtRisk":159}]},{"term":"Second and third trimester","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fetal losses","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":160},{"groupId":"EG003","numAffected":0,"numAtRisk":159}]},{"term":"Gestational diabetes mellitus","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":160},{"groupId":"EG001","numAffected":3,"numAtRisk":159},{"groupId":"EG002","numAffected":0,"numAtRisk":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0}]},{"term":"Preeclampsia","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":160},{"groupId":"EG001","numAffected":8,"numAtRisk":159},{"groupId":"EG002","numAffected":0,"numAtRisk":0},{"groupId":"EG003","numAffected":0,"numAtRisk":0}]},{"term":"neonatal hypoglycemia","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Glucose levels ≤ 40 mg/dL at 1, 2 or 4 hours after birth","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":15,"numAtRisk":91},{"groupId":"EG003","numAffected":3,"numAtRisk":140}]},{"term":"neonatal death","organSystem":"Pregnancy, puerperium and perinatal conditions","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":0},{"groupId":"EG001","numAffected":0,"numAtRisk":0},{"groupId":"EG002","numAffected":8,"numAtRisk":91},{"groupId":"EG003","numAffected":0,"numAtRisk":140}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Silvia Hoirisch-Clapauch","organization":"Hospital Federal dos Servidores do Estado","email":"sclapauch@gmail.com","phone":"55-21-999737500"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D006946","term":"Hyperinsulinism"},{"id":"D000022","term":"Abortion, Spontaneous"},{"id":"D057185","term":"Sedentary Behavior"},{"id":"D007003","term":"Hypoglycemia"},{"id":"D009043","term":"Motor Activity"},{"id":"D000026","term":"Abortion, Habitual"},{"id":"D047928","term":"Premature Birth"}],"ancestors":[{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D011248","term":"Pregnancy Complications"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D001519","term":"Behavior"},{"id":"D007752","term":"Obstetric Labor, Premature"},{"id":"D007744","term":"Obstetric Labor Complications"}]}},"hasResults":true}