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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05305326

Enrollment

Registered

2022-03-31

Start date

2021-12-01

Completion date

2022-12-31

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes in Pregnancy

Keywords

pregnancy, diabetes, telocytes, placenta, umbilical cord

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactAmr O Abdelkareem, MD

amr.oth@med.sohag.edu.eg00201001259562

Backup ContactHatem A Awaga, MD

hatemaboelftooh@yahoo.com00201550777310

Outcome results