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

Study Overview
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Brief Summary
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Examining the expression of telocytes in the placental tissues and umbilical cord of patients with gestational or pregestational diabetes during pregnancy compared to control.

Detailed Description
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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.

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

Conditions
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Diabetes in Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All pregnant women presented at the delivery ward in Sohag University Hospital, Sohag, Egypt with the following criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Singleton pregnancies undergoing elective pre-labour CS at gestational age (37+0 to 40+0) that are healthy | |
| Gestational diabetes<br>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<br>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<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, diabetes, telocytes, placenta, umbilical cord