NCT06644521

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 14, 2024

Last Update Submit

October 15, 2024

Conditions

Keywords

COVID-19placentaVEGFVEGFR-1PDGFimmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (2)

Group 1: COVID-19 group

Group 2: Control

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Covid-19 patients while pregnancy

You may qualify if:

  • Covid-19 patients while pregnancy
  • Age range 18-50
  • Being literate in Turkish
  • Not having any additional disease
  • Agreeing to participate in the study

You may not qualify if:

  • 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 Covid-19 while pregnancy included in the control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

placenta tissues

MeSH Terms

Conditions

COVID-19Placenta Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
16 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 16, 2024

Study Start

December 1, 2020

Primary Completion

January 1, 2022

Study Completion

April 17, 2023

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations