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

NCT05305326 | Unknown

• 1 other identifier: Soh-Med-21-12-39
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes in Pregnancy

Keywords

pregnancy; diabetes; telocytes; placenta; umbilical cord

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty of Medicine

Sohag, 82514, Egypt

RECRUITING

Related Publications (7)

• Blanco MV, Vega HR, Giuliano R, Grana DR, Azzato F, Lerman J, Milei J. Histomorphometry of umbilical cord blood vessels in preeclampsia. J Clin Hypertens (Greenwich). 2011 Jan;13(1):30-4. doi: 10.1111/j.1751-7176.2010.00384.x. Epub 2010 Nov 4.

  PMID: 21214719 BACKGROUND

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available.

  PMID: 29650105 BACKGROUND

• Feig DS, Razzaq A, Sykora K, Hux JE, Anderson GM. Trends in deliveries, prenatal care, and obstetrical complications in women with pregestational diabetes: a population-based study in Ontario, Canada, 1996-2001. Diabetes Care. 2006 Feb;29(2):232-5. doi: 10.2337/diacare.29.02.06.dc05-1482.

  PMID: 16443865 BACKGROUND

• Nizyaeva NV, Sukhacheva TV, Serov RA, Kulikova GV, Nagovitsyna MN, Kan NE, Tyutyunnik VL, Pavlovich SV, Poltavtseva RA, Yarotskaya EL, Shchegolev AI, Sukhikh GT. Ultrastructural and Immunohistochemical Features of Telocytes in Placental Villi in Preeclampsia. Sci Rep. 2018 Feb 22;8(1):3453. doi: 10.1038/s41598-018-21492-w.

  PMID: 29472628 BACKGROUND

• Chamberlain JJ, Rhinehart AS, Shaefer CF Jr, Neuman A. Diagnosis and Management of Diabetes: Synopsis of the 2016 American Diabetes Association Standards of Medical Care in Diabetes. Ann Intern Med. 2016 Apr 19;164(8):542-52. doi: 10.7326/M15-3016. Epub 2016 Mar 1.

  PMID: 26928912 BACKGROUND

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.

  PMID: 30461693 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fragments of the central part of the placenta Small section of the umbilical cord

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Amr O Abdelkareem, MD

  Sohag Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr O Abdelkareem, MD

CONTACT

00201001259562; amr.oth@med.sohag.edu.eg

Hatem A Awaga, MD

CONTACT

00201550777310; hatemaboelftooh@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2024 and up to 5 years duration
• Access Criteria: email amr.oth@med.sohag.edu.eg

Locations

EG (1)