Clinical trial NCT03265704: Maternal High Blood Pressure and Newborn's Blood Profile
Official title: Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal-Fetal Exchange
Keywords: Maternal PIH
Neonatal thrombocytopenia
Neonatal neutropenia
Lead sponsor: Romanian Society of Anesthesia and Intensive Care
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: Timişoara County Emergency Clinical Hospital
First posted: 2017-08-29
Enrollment: 6108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newborns admitted to the Neonatology Department who met the Inclusion Criteria.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age: 0-28 days
* Newborns of healthy mothers;
* Newborns of mothers with Pregnancy Induced Hypertension;
* Inborn Patients;
* Written Informed Consent signed by legal guardian.

Exclusion Criteria:

* Maternal disease other than PIH;
* Syndromal, chromosomal or infectious diseases of the newborns;
* Causes other then PIH for perinatal asphyxia.

Primary outcomes:
measure: Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension
timeFrame: Blood profiles of newborns aged between 1-28 days were evaluated.
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Romanian Society of Anesthesia and Intensive Care
Study officials:
affiliation: Romanian Society of Anesthesia and Intensive Care
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
References:
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.
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.
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.
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.