Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-01 @ 11:24 AM
Study NCT ID:
NCT03265704
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2017-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal High Blood Pressure and Newborn's Blood Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054098', 'term': 'Thrombocytopenia, Neonatal Alloimmune'}], 'ancestors': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-26', 'studyFirstSubmitDate': '2017-08-26', 'studyFirstSubmitQcDate': '2017-08-26', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension', 'timeFrame': 'Blood profiles of newborns aged between 1-28 days were evaluated.', 'description': 'Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maternal PIH', 'Neonatal thrombocytopenia', 'Neonatal neutropenia'], 'conditions': ['Maternal-Fetal Exchange']}, 'referencesModule': {'references': [{'pmid': '18759083', 'type': 'BACKGROUND', 'citation': 'Bhat YR, Cherian CS. Neonatal thrombocytopenia associated with maternal pregnancy induced hypertension. Indian J Pediatr. 2008 Jun;75(6):571-3. doi: 10.1007/s12098-008-0110-x. Epub 2008 Aug 31.'}, {'pmid': '21547086', 'type': 'BACKGROUND', 'citation': 'Backes CH, Markham K, Moorehead P, Cordero L, Nankervis CA, Giannone PJ. Maternal preeclampsia and neonatal outcomes. J Pregnancy. 2011;2011:214365. doi: 10.1155/2011/214365. Epub 2011 Apr 4.'}, {'pmid': '9215266', 'type': 'BACKGROUND', 'citation': 'de Zegher F, Francois I, van Helvoirt M, Van den Berghe G. Clinical review 89: Small as fetus and short as child: from endogenous to exogenous growth hormone. J Clin Endocrinol Metab. 1997 Jul;82(7):2021-6. doi: 10.1210/jcem.82.7.4007. No abstract available.'}, {'pmid': '26459642', 'type': 'BACKGROUND', 'citation': 'Christensen RD, Yoder BA, Baer VL, Snow GL, Butler A. Early-Onset Neutropenia in Small-for-Gestational-Age Infants. Pediatrics. 2015 Nov;136(5):e1259-67. doi: 10.1542/peds.2015-1638. Epub 2015 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.', 'detailedDescription': 'Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. The endothelium has been identified as the target tissue of the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. This study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. The current retrospective observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to December 2016. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Neonatology Department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All newborns admitted to the Neonatology Department who met the Inclusion Criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 0-28 days\n* Newborns of healthy mothers;\n* Newborns of mothers with Pregnancy Induced Hypertension;\n* Inborn Patients;\n* Written Informed Consent signed by legal guardian.\n\nExclusion Criteria:\n\n* Maternal disease other than PIH;\n* Syndromal, chromosomal or infectious diseases of the newborns;\n* Causes other then PIH for perinatal asphyxia.'}, 'identificationModule': {'nctId': 'NCT03265704', 'acronym': 'MPIHHPN', 'briefTitle': "Maternal High Blood Pressure and Newborn's Blood Profile", 'organization': {'class': 'OTHER', 'fullName': 'Romanian Society of Anesthesia and Intensive Care'}, 'officialTitle': 'Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns', 'orgStudyIdInfo': {'id': '201601MP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AGA Neonates', 'description': 'AGA Control Group Appropriate for gestational age newborns of healthy mothers', 'interventionNames': ['Other: AGA - Control group']}, {'label': 'SGA Neonates', 'description': 'SGA - Control Group Small for gestational age newborns of healthy mothers', 'interventionNames': ['Other: SGA - Control group']}, {'label': 'AGA-PIH Neonates', 'description': 'AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension', 'interventionNames': ['Other: AGA-PIH Study group']}, {'label': 'SGA-PIH Neonates', 'description': 'SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension', 'interventionNames': ['Other: SGA-PIH Study group']}], 'interventions': [{'name': 'AGA - Control group', 'type': 'OTHER', 'description': 'Data processing from Patient Medical Files', 'armGroupLabels': ['AGA Neonates']}, {'name': 'SGA - Control group', 'type': 'OTHER', 'description': 'Data processing from Patient Medical Files', 'armGroupLabels': ['SGA Neonates']}, {'name': 'AGA-PIH Study group', 'type': 'OTHER', 'description': 'Monitoring PIH-related changes in the newborn', 'armGroupLabels': ['AGA-PIH Neonates']}, {'name': 'SGA-PIH Study group', 'type': 'OTHER', 'description': 'Monitoring PIH-related changes in the newborn', 'armGroupLabels': ['SGA-PIH Neonates']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Timișoara', 'country': 'Romania', 'facility': 'Romanian Society of Anesthesia and Intensive Care', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Alexandru Florin Rogobete, PhDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Romanian Society of Anesthesia and Intensive Care'}, {'name': 'Dorel Sandesc, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Romanian Society of Anesthesia and Intensive Care'}, {'name': 'Ovidiu Bedreag, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Romanian Society of Anesthesia and Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Romanian Society of Anesthesia and Intensive Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Medicine and Pharmacy "Victor Babes" Timisoara', 'class': 'OTHER'}, {'name': 'Timişoara County Emergency Clinical Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, PhDs, Clinical Researcher', 'investigatorFullName': 'Alexandru Florin Rogobete', 'investigatorAffiliation': 'Romanian Society of Anesthesia and Intensive Care'}}}}