Maternal High Blood Pressure and Newborn's Blood Profile

Maternal-Fetal Exchange Clinical Trial

— MPIHHPN  

Official title:

Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265704
• Other study ID #: 201601MP
• Status: Completed
• Phase: N/A
• First received: August 26, 2017
• Last updated: August 26, 2017
• Start date: January 1, 2016
• Est. completion date: August 25, 2017

Study information

• Verified date: August 2017
• Source: Romanian Society of Anesthesia and Intensive Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6108
• Est. completion date: August 25, 2017
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Maternal-Fetal Exchange

Intervention

Other:
• AGA - Control group
Data processing from Patient Medical Files
• SGA - Control group
Data processing from Patient Medical Files
• AGA-PIH Study group
Monitoring PIH-related changes in the newborn
• SGA-PIH Study group
Monitoring PIH-related changes in the newborn

Locations

Country	Name	City	State
Romania	Romanian Society of Anesthesia and Intensive Care	Timisoara

Sponsors (3)

Lead Sponsor	Collaborator
Romanian Society of Anesthesia and Intensive Care	Timisoara County Emergency Clinical Hospital, University of Medicine and Pharmacy "Victor Babes" Timisoara

Country where clinical trial is conducted

Romania, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension	Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.	Blood profiles of newborns aged between 1-28 days were evaluated.