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NCT06668545Completed

Investigating CD 71 in Preeclamptic Pregnancies

Immunohistochemical Analysis of CD 71 Levels in the Placenta of Preeclamptic and Normotensive Pregnancies and Comparison With Neonatal Outcomes

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
39 (actual)
First submitted
30 Oct 2024
Start date
23 Oct 2024
Primary completion date
17 Jan 2025
Lead sponsor
Manisa Celal Bayar University
NCT number
NCT06668545

What you commit to

  • Study type: Observational
  • Participants enrolled: 39
  • From 23 Oct 2024 to the primary completion date, 17 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medication use (excluding routinely used food supplements during pregnancy)

Other illness

  • High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
  • Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
  • Presence of active or chronic infection
  • Presence of active or chronic inflammatory disease

Age

  • Pregnant women under the age of 18

Other

  • Multiple pregnancy
  • Smoking
  • Immunosuppressive use
  • Patients who gave birth at an external center or later chose to withdraw from the study
  • Patients who did not have any exclusion criteria at the time of Preeclampsi or when blood was drawn for the control group, but who later developed any exclusion criteria.
  • Premature birth of patients included in the control group

Who the study is looking for

  • Healthy pregnancy under 37 weeks
  • Age range 18-50
  • Being literate in Turkish
  • Not having any additional disease
  • Agreeing to participate in the study

Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kemal Sarsmaz
Coordinator of this site? Confirm its status
ManisaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.