Telocytes in Placental Tissues of Patients With Gestational and Pre-gestational Diabetes

March 22, 2022 updated by: Amr Othman Abdelkareem Mohammad Ahmad, Sohag University
Examining the expression of telocytes in the placental tissues and umbilical cord of patients with gestational or pregestational diabetes during pregnancy compared to control.

Study Overview

Status

Recruiting

Conditions

Detailed Description

this is an observational study, patients with gestational or pre-gestational diabetes undergoing elective (pre-labour) Cesarean section will be asked to participate in the study. Samples of placenta and umbilical cord will be taken postpartum and will be fixed and examined using immunohistochemistry to measure abundance of telocytes in these tissues. another group of patients with non complicated pregnancies will be asked to join as a control. As the topic was never studied before, a pilot phase of 10 patients per group will be done followed by sample size collection based on SD of number of telocytes in each group. Diabetes patients will divided in 3 subgroups; Gestational diabetes and pre-gestational diabetes type 1 or 2. Each group will be further subdivided according to HBA1C level collected at the time of delivery into controlled or non controlled.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All pregnant women presented at the delivery ward in Sohag University Hospital, Sohag, Egypt fulfilling the inclusion criteria. A pilot phase will include 10 patients in each group. Based on primary analysis, proper sample size will be calculated.

Description

Inclusion Criteria:

  • All pregnant women presented at the delivery ward in Sohag University Hospital, Sohag, Egypt with the following criteria:

    1. Study group: Singleton pregnancies complicated with diabetes undergoing pre-labour CS at gestational age (37+0 to 40+0). These will be divided into 3 groups according to the type of disease either Gestational diabetes (Group A), pregestational diabetes type 1 (Group B) or type 2 (Group C). 2-Control group: Singleton pregnancies undergoing elective pre-labour CS at gestational age (37+0 to 40+0) that are otherwise healthy

Exclusion Criteria:

  • Women with history of medical co-morbidities other than diabetes are excluded from the study. This includes the following: Chronic hypertension, renal diseases, autoimmune diseases, history of organ transplantation and immunosuppressive therapy, hematological diseases, history of thrombotic events, cardiopulmonary diseases, liver diseases Acute and chronic inflammatory diseases.
  • Pregnancy induced medical disorders like: Gestational hypertension, preeclampsia, Gestational thrombocytopenia, and proteinuria.
  • Multiple pregnancies.
  • Abnormal placentation, i.e. Placenta previa and Morbidly adherent placenta.
  • Fetal anomalies.
  • vaginal deliveries and CS in labor.
  • Spontaneous delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Control
Singleton pregnancies undergoing elective pre-labour CS at gestational age (37+0 to 40+0) that are healthy
Gestational diabetes
Singleton pregnancies complicated with gestational diabetes undergoing pre-labour CS at gestational age (37+0 to 40+0) that are otherwise healthy
Type 1 diabetes with pregnancy
Singleton pregnancies complicated with Type 1 diabetes undergoing pre-labour CS at gestational age (37+0 to 40+0) that are otherwise healthy
Type 2 diabetes with pregnancy
Singleton pregnancies complicated with Type 2 diabetes undergoing pre-labour CS at gestational age (37+0 to 40+0) that are otherwise healthy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telocytes
Time Frame: Telocytes will be assessed in placental and umbilical cord tissues fixed immediately after delivery.
number of telocytes per high power field detected by IHC
Telocytes will be assessed in placental and umbilical cord tissues fixed immediately after delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Amr O Abdelkareem, MD, Sohag Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-12-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

on personal request de-identified IPD could be shared in the form of Telocytes score of placenta and cord and statistical analysis done.

IPD Sharing Time Frame

January 2024 and up to 5 years duration

IPD Sharing Access Criteria

email amr.oth@med.sohag.edu.eg

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes in Pregnancy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe