COVID-19NCT06644521
Angiogenic Factors in the Placentas of Women With COVID-19
An observational study of COVID-19 and Placenta Diseases, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Aim: There have been few studies since the beginning of the pandemic researching the histopathologies and conducting molecular investigations of the placentas of SARS-CoV-2 positive pregnant women. 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
- COVID-19, Placenta Diseases, Angiogenesis
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 17 Apr 2023
- How long will I take part?
- 16 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: Covid-19 patients while pregnancy
Who may be able to join
- Covid-19 patients while pregnancy
- 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 11Show 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 Covid-19 while pregnancy included in the control group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Angiogenic Factors in the Placentas of Parturient Women With COVID-19
Aim: There have been few studies since the beginning of the pandemic researching the histopathologies and conducting molecular investigations of the placentas of SARS-CoV-2 positive pregnant women. The aim of this study was to analyze the changes in the expression of angiogenic growth factors in the placentas of pregnant women infected with SARS-CoV-2 (the COVID-19 group), and to make comparisons with the placentas of non-infected pregnant women (the control group).
Methods: Placentas taken at birth from 20 healthy women (control) and 20 women with a positive test for COVID-19 were prepared for histopathological examination. Immunohistochemical staining was applied in placental tissues with ACE2 (Angiotensin-conversion enzyme-2), VEGF (Vascular Endothelial Growth Factor), VEGFR-1 (Vascular Endothelial Growth Factor Receptor 1) and PDGF (Platelet-Derived Growth Factor).
Results: First, the presence of COVID-19 in the placental tissue was assessed by the ACE2 immunohistochemical method. It was seen that ACE2 was expressed weakly in the placental syncytiotrophoblast cells of non-infected women, but in the syncytiotrophoblasts of the placentas of women infected with COVID-19, ACE2 expression was much higher. VEGF in the endothelial and stromal cells of the villi of the control group was very strong, but in the villi of infected placentas it was significantly weaker. VEGFR-1 was positive in the endothelial membranes of the villi of the control group, but was significantly weaker in the villi of infected placentas. PDGF expression was strong in the syncytiotrophoblast and stromal cells of the control group, but was significantly noticeably weaker in COVID-19 positive placentas.
- Conditions
- COVID-19, Placenta Diseases, Angiogenesis
- Keywords
- COVID-19, placenta, VEGF, VEGFR-1, PDGF, immunohistochemistry
- Medical subject headings
- COVID-19, 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: COVID-19 group | Not described | |
| Group 2: Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of 40 participant include this stuedy. Taken 2% of Covid-19 placenta tissues and 2% of normal placenta tissues while birth. Placenta tissues were stained by ACE2, VEGF, VEGFR-1, PDGF 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 posted16 Oct 2024
- Study start1 Dec 2020
- Primary completion1 Jan 2022
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 40 participants (actual)
- Target duration
- 16 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
- NCT06644521
- Sponsor's protocol ID
- MCBU_Covidplasenta
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Angiogenic Factors in the Placentas of Parturient Women With COVID-19
- ClinicalTrials.gov ID
- NCT06644521
- Acronym / sponsor ID
- MCBU_Covidplasenta
- Conditions
- COVID-19, Placenta Diseases, Angiogenesis
- Keywords
- COVID-19, placenta, VEGF, VEGFR-1, PDGF, immunohistochemistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 16 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.
Aim: There have been few studies since the beginning of the pandemic researching the histopathologies and conducting molecular investigations of the placentas of SARS-CoV-2 positive pregnant women. The aim of this study was to analyze the changes in the expression of angiogenic growth factors in the placentas of pregnant women infected with SARS-CoV-2 (the COVID-19 group), and to make comparisons with the placentas of non-infected pregnant women (the control group).
Methods: Placentas taken at birth from 20 healthy women (control) and 20 women with a positive test for COVID-19 were prepared for histopathological examination. Immunohistochemical staining was applied in placental tissues with ACE2 (Angiotensin-conversion enzyme-2), VEGF (Vascular Endothelial Growth Factor), VEGFR-1 (Vascular Endothelial Growth Factor Receptor 1) and PDGF (Platelet-Derived Growth Factor).
Results: First, the presence of COVID-19 in the placental tissue was assessed by the ACE2 immunohistochemical method. It was seen that ACE2 was expressed weakly in the placental syncytiotrophoblast cells of non-infected women, but in the syncytiotrophoblasts of the placentas of women infected with COVID-19, ACE2 expression was much higher. VEGF in the endothelial and stromal cells of the villi of the control group was very strong, but in the villi of infected placentas it was significantly weaker. VEGFR-1 was positive in the endothelial membranes of the villi of the control group, but was significantly weaker in the villi of infected placentas. PDGF expression was strong in the syncytiotrophoblast and stromal cells of the control group, but was significantly noticeably weaker in COVID-19 positive placentas.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 16 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: COVID-19 group | – | – |
| Group 2: Control | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Covid-19 patients while pregnancy
Key inclusion criteria (5 listed)
- Covid-19 patients while pregnancy
- Age range 18-50
- Being literate in Turkish
- Not having any additional disease
- Agreeing to participate in the study
Key exclusion criteria (11 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
Number of 40 participant include this stuedy. Taken 2% of Covid-19 placenta tissues and 2% of normal placenta tissues while birth. Placenta tissues were stained by ACE2, VEGF, VEGFR-1, PDGF 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 16 Oct 2024.
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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 COVID-19 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 11 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 16 Oct 2024. 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?
Number of 40 participant include this stuedy. Taken 2% of Covid-19 placenta tissues and 2% of normal placenta tissues while birth. Placenta tissues were stained by ACE2, VEGF, VEGFR-1, PDGF 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 16 Oct 2024.