CClinicalTrials.gg
CompletedNCT06668545Updated Nov 21, 2025

Investigating CD 71 in Preeclamptic Pregnancies

An observational study in Preeclampsia and Placenta Diseases, sponsored by Manisa Celal Bayar University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Manisa Celal Bayar University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
39
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Preeclampsia
  • Placenta Diseases

Keywords

  • Preeclampsia
  • inos
  • enos
  • cd71
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 39 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Manisa Celal Bayar University is the lead sponsor of 27 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Preeclampsi Patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
  • Multiple pregnancy
  • Pregnant women under the age of 18
  • Smoking
  • Medication use (excluding routinely used food supplements during pregnancy)
  • Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
  • Immunosuppressive use
  • Presence of active or chronic infection
  • Presence of active or chronic inflammatory disease
  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
39 participants (actual)
Target follow-up
8 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1:

    Patients with preeclampsia

  • Group 2:

    Patients without preeclampsia

06

What researchers measure

Primary outcomes

  1. 2% women's with PPROM placenta tissues and umblical cord while birth. Placenta tissues and umblical cord Staining will be Measured by inos,enos,cd71 immunohistochemistry

    Time frame: Baseline

07

Study locations

1 site
  • Kemal Sarsmaz
    Manisa, Yunusemre, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06668545
Lead sponsor
Manisa Celal Bayar University
Responsible party
Sponsor
First posted
Oct 31, 2024
Start date
Oct 23, 2024
Primary completion
Jan 17, 2025
Completion
May 5, 2025
Last update
Nov 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion