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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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Inclusion Criteria:
All pregnant women presented at the delivery ward in Sohag University Hospital, Sohag, Egypt with the following criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr O Abdelkareem, MD | Contact | 00201001259562 | amr.oth@med.sohag.edu.eg | |
| Hatem A Awaga, MD | Contact | 00201550777310 | hatemaboelftooh@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Amr O Abdelkareem, MD | Sohag Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag Faculty of Medicine | Recruiting | Sohag | 82514 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21214719 | Background | 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. | |
| 29650105 | 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. |
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on personal request de-identified IPD could be shared in the form of Telocytes score of placenta and cord and statistical analysis done.
January 2024 and up to 5 years duration
email amr.oth@med.sohag.edu.eg
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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Fragments of the central part of the placenta Small section of the umbilical cord
| 16443865 | 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. |
| 29472628 | 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. |
| 26928912 | 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. |
| 29370047 | Background | ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. |
| 30461693 | 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |