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Immunohistochemical Analysis of CD 71 Levels in the Placenta of Preeclamptic and Normotensive Pregnancies and Comparison With Neonatal Outcomes
Objective: Upon reviewing studies aimed at understanding and investigating the pathogenesis of preeclampsia, it has been observed that CD71 has not been previously examined. Therefore, the increase in CD71 is associated with placental dysfunction and mechanisms affecting fetal growth restriction. The exact pathogenesis of CD71, which is known to play a role in such mechanisms, has not been fully understood. Consequently, this study may contribute to understanding and elucidating the development of preeclampsia. This study aims to investigate the levels of CD71 and NOS in the placentas of pregnant women with high and normal blood pressure and to compare these findings with neonatal outcomes. Method: This prospective randomized controlled study will be conducted at the Department of Obstetrics and Gynecology, Manisa Celal Bayar University, involving patients diagnosed with preeclampsia. The planned sample size was calculated using the G power 3.1.9.7 program, with an effect size of 1.153, 95% power, and a 0.5% type I error rate. The calculated sample size for the case group is 39 and for the control group is also 39. When the planned sample size is reached, sample collection will be terminated, and histopathological examinations will be conducted. Study Group: Patients with preeclampsia Control Group: Patients without preeclampsia During the hospitalization of the preeclampsia patients for delivery, after clamping of the umbilical cord following the birth of the baby (after the connection between mother and baby has ceased), a 2 ml (one teaspoon) blood sample will be taken from the cord blood, centrifuged, and the serum sample will be separated and stored at -80 degrees Celsius. In the post-delivery process, a 3x3 cm piece will be taken from the umbilical cord, which will be disposed of as medical waste, and from the placenta (the baby's afterbirth), encompassing all layers. The collected tissue samples will be preserved in a container with 10% formalin. At the time of sample collection, both the cord blood and placenta samples will be in a waste state, ensuring that there is no connection left between the mother and baby, thus eliminating any risk of harm to either during the sampling process. The tissues (placenta, umbilical cord) and the 2 ml (one teaspoon) blood sample from the umbilical cord will be collected, centrifuged, and the serum sample separated, to be stored at -80 degrees Celsius for future similar studies and projects. Preeclampsia is a serious complication during pregnancy that poses potential risks to both the mother and the baby. Early diagnosis and appropriate management can reduce complications and safeguard maternal-fetal health. Biomarkers of preeclampsia play a significant role in the understanding and management of the disease.
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
Yes
Kemal Sarsmaz
Manisa, Yunusemre, Turkey (Türkiye)
Start Date
October 23, 2024
Primary Completion Date
January 17, 2025
Completion Date
May 5, 2025
Last Updated
November 21, 2025
39
ACTUAL participants
Lead Sponsor
Celal Bayar University
NCT07485140
NCT06749418
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05999851