Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 1:18 PM
Study NCT ID:
NCT06917833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079262', 'term': 'Pregnancy in Obesity'}, {'id': 'D001238', 'term': 'Asphyxia Neonatorum'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 544}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of admission to neonatal observation room', 'timeFrame': '6 hours post delivery'}], 'secondaryOutcomes': [{'measure': 'Rate of cesarean-sections.', 'timeFrame': '12 hours'}, {'measure': 'Oxygen saturation at birth.', 'timeFrame': '2 hours post delivery'}, {'measure': 'Number of babies with NICU Admission.', 'timeFrame': '6 hours post delivery'}, {'measure': 'Number of babies with birth trauma.', 'timeFrame': '2 hours post delivery'}, {'measure': 'Number of babies with meconium aspiration.', 'timeFrame': '2 hours post delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maternal obesity', 'hypoxia neonatal'], 'conditions': ['Maternal Obesity', 'Hypoxia Neonatal']}, 'descriptionModule': {'briefSummary': 'Offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal BMI. In terms of Apgar scores at birth, babies of obese mothers have been reported to have a 31% excess risk of having a low Apgar score (defined at \\<7 at 1 minute) . Infants born to obese mothers demonstrate a spectrum of outcomes, suggesting that there is a complex interplay of factors that defines the precise altered metabolic environment to which the fetus is exposed and that determines the risk of complications', 'detailedDescription': 'The investigators need to improve understanding of the specific molecular factors that contribute either individually or synergistically to detrimental fetal outcomes. Moreover, The investigators need to identify the essential maternal markers that need to be tightly regulated during pregnancy to improve outcomes. Here in, The investigators discuss the influence of maternal obesity and factors associated with the obesogenic intrauterine environment on fetal lung development and respiratory outcomes in offspring at birth importantly, The investigators identify a series of molecular changes encountered during pregnancy that may program the observed respiratory outcomes in clinical practice. The effects of maternal obesity on severe neonatal asphyxia may be partly explained by traumatic labor, which often results from macrosomia. Another consequence of maternal obesity is fetal hyperinsulinemia, which may be related to chronic hypoxia even without diabetes . Other mechanisms that explain the effect of maternal obesity on neonatal asphyxia include lipotoxicity, placental inflammation and vasculopathy, and cord coiling. Evidence has demonstrated altered gene expression in full-term newborns of mothers with obesity, involving dysregulation of brain development, inflammatory and immune signaling, glucose and lipid homeostasis, and oxidative stress'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18 - 40 years pregnant females 37 weeks or more', 'genderDescription': 'pregnant females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of 18 - 40 years.\n2. Term pregnancy (37 weeks gestation or more)\n3. Singleton pregnancy\n4. Cephalic presentation at time of delivery\n5. In labour\n\nExclusion Criteria:\n\n1. Any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders)\n2. Scarred uterus (myomectomy, previous cesarean section)\n3. Macrosomic baby\\>4 kgs\n4. Condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological CTG, cord prolapse)\n5. Liquor abnormalities (oligohydramnios or polyhydramnios).\n6. Other indications for cesarean sections for example: placenta accreta spectrum\n7. Smokers.\n8. Any abnormalities in follow up of delivery regarding partogram.'}, 'identificationModule': {'nctId': 'NCT06917833', 'briefTitle': 'Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.', 'orgStudyIdInfo': {'id': 'MD344/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A (case group )', 'description': 'women with body mass index equal to 25 kg/m2 or more at time of delivery.', 'interventionNames': ['Other: compare infant hypoxic events in both groups']}, {'label': 'group B ( control group )', 'description': 'women with body mass index (18.5-24.9 kg/m2) at time of delivery', 'interventionNames': ['Other: compare infant hypoxic events in both groups']}], 'interventions': [{'name': 'compare infant hypoxic events in both groups', 'type': 'OTHER', 'description': 'early neonatal resuscitation will be done by the pediatrician according to the guidelines, APGAR score of the baby will be calculated,, any hypoxic events will be traced and any need of respiratory support for the baby or NICU admission, as well as weight of the baby, mode of delivery and any birth traumas will be recorded.all this will be compared between two groups.', 'armGroupLabels': ['group A (case group )', 'group B ( control group )']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esraa Hussein, master', 'role': 'CONTACT', 'email': 'esraaghoneimy81@gmail.com', 'phone': '01008057054'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}