PreeclampsiaNCT06668545
Investigating CD 71 in Preeclamptic Pregnancies
An observational study of Preeclampsia and Placenta Diseases, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Placenta Diseases
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2024to 5 May 2025
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Preeclampsi Patients
Who may be able to join
- Healthy pregnancy under 37 weeks
- Age range 18-50
- Being literate in Turkish
- Not having any additional disease
- Agreeing to participate in the study
Who cannot join
- 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.)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Preeclampsia, Placenta Diseases
- Keywords
- Preeclampsia, inos, enos, cd71
- Medical subject headings
- Pre-Eclampsia, Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Patients with preeclampsia | |
| Group 2: | Patients without preeclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start23 Oct 2024
- Primary completion17 Jan 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668545
- Sponsor's protocol ID
- MCBU_Preeklampsi
- Status last verified
- Nov 2025
- First submitted
- 30 Oct 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Analysis of CD 71 Levels in the Placenta of Preeclamptic and Normotensive Pregnancies and Comparison With Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT06668545
- Acronym / sponsor ID
- MCBU_Preeklampsi
- Conditions
- Preeclampsia, Placenta Diseases
- Keywords
- Preeclampsia, inos, enos, cd71
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: | – | –Patients with preeclampsia |
| Group 2: | – | –Patients without preeclampsia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Preeclampsi Patients
Key inclusion criteria (5 listed)
- Healthy pregnancy under 37 weeks
- Age range 18-50
- Being literate in Turkish
- Not having any additional disease
- Agreeing to participate in the study
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Placenta Diseases, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.