Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:21 PM
Study NCT ID:
NCT07337759
Status:
COMPLETED
Last Update Posted:
2026-01-13
First Post:
2026-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetus Programming and Long Active Outcomes, Interaction Between Mother, Placenta and Fetus in Perinatal and Methabolic Disbalansces-focusing Diabetic Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-04', 'studyFirstSubmitDate': '2026-01-04', 'studyFirstSubmitQcDate': '2026-01-04', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse perinatal outcome defined as at least one of the following: delivery before 34 gestational weeks, birth weight below 2200 g, or Apgar score <7 at 5 minutes.', 'timeFrame': 'From delivery to 5 minutes after birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placental Insufficiency Hypertensive Disorders of Pregnancy Diabetes Mellitus in Pregnancy Thrombophilia in Pregnancy Adverse Perinatal Outcomes']}, 'descriptionModule': {'briefSummary': 'The placenta is a temporary but essential organ that develops during pregnancy and supports the growth and survival of the fetus. It delivers oxygen and nutrients from the mother to the baby and removes waste products from the fetal circulation. Proper placental development and function are critical for a healthy pregnancy and good outcomes for both the mother and the newborn.\n\nWhen the placenta does not grow or function properly, this condition is known as placental insufficiency. Placental insufficiency may lead to serious pregnancy complications, such as poor fetal growth, preterm birth, low birth weight, low Apgar scores, and increased risk of illness or death around the time of birth. In some cases, placental dysfunction may also contribute to maternal complications, including pregnancy-related hypertension.\n\nPrevious research has shown that simple physical characteristics of the placenta-such as its weight, size, thickness, and surface area-may reflect how well the placenta functions. Placentas that are smaller than expected for a given gestational age may indicate long-standing problems with blood flow between the mother and the fetus. However, these measurements are not yet routinely used as clinical markers of risk.\n\nThe purpose of this study was to examine whether placental weight, placental surface area, placental disk weight, and related histopathological changes are associated with adverse perinatal outcomes. The study included both healthy pregnant women and women with medical conditions known to affect pregnancy, such as hypertension, diabetes mellitus, and thrombophilia. Special attention was given to placentas classified as small for gestational age (SGA-P) compared with placentas appropriate for gestational age (AGA-P).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with singleton pregnancies who delivered at the Clinic of Gynecology and Obstetrics, University Clinical Centre of Serbia. The study population includes both healthy pregnant women and women with maternal comorbidities such as hypertensive disorders, diabetes mellitus, and thrombophilia. Placentas were examined after delivery and classified according to placental weight for gestational age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Pregnant women who delivered at the Clinic of Gynecology and Obstetrics, University Clinical Centre of Serbia\n\n* Singleton pregnancy\n* Available placental examination after delivery\n* Available clinical and perinatal outcome data\n* Gestational age at delivery ≥24 weeks\n\nExclusion Criteria:\n\nMultiple pregnancy (e.g., twins or higher-order gestations)\n\n* Major congenital or chromosomal fetal anomalies\n* Intrauterine fetal demise\n* Conditions directly affecting placental weight (e.g., placental mosaicism)\n* Incomplete clinical, placental, or histopathological data'}, 'identificationModule': {'nctId': 'NCT07337759', 'briefTitle': 'Fetus Programming and Long Active Outcomes, Interaction Between Mother, Placenta and Fetus in Perinatal and Methabolic Disbalansces-focusing Diabetic Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Placental Weight and Surface as an Indicator of Placental Insufficiency and Adverse Perinatal Outcomes', 'orgStudyIdInfo': {'id': '1880/6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Appropriate-for-Gestational-Age Placenta (AGA-P)', 'description': 'regnant women whose placentas had a weight between the 10th and 90th percentile for gestational age.', 'interventionNames': ['Other: No intervention (observational study)']}, {'label': 'Small-for-Gestational-Age Placenta (SGA-P)', 'description': 'Pregnant women whose placentas had a weight below the 10th percentile for gestational age.', 'interventionNames': ['Other: No intervention (observational study)']}], 'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'observational study', 'armGroupLabels': ['Appropriate-for-Gestational-Age Placenta (AGA-P)', 'Small-for-Gestational-Age Placenta (SGA-P)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinic of Gynecology and Obstetrics, University Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr', 'investigatorFullName': 'Miroslava Gojnic Dugalic', 'investigatorAffiliation': 'University of Belgrade'}}}}