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

NCT ID: NCT05305326

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-31

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.

Conditions

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Diabetes in Pregnancy

Keywords

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pregnancy diabetes telocytes placenta umbilical cord

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Singleton pregnancies undergoing elective pre-labour CS at gestational age (37+0 to 40+0) that are healthy

No interventions assigned to this group

Gestational diabetes

Singleton pregnancies complicated with gestational diabetes undergoing pre-labour CS at gestational age (37+0 to 40+0) that are otherwise healthy

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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:

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Amr Othman Abdelkareem Mohammad Ahmad

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr O Abdelkareem, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag Faculty of Medicine

Locations

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Sohag Faculty of Medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr O Abdelkareem, MD

Role: CONTACT

Phone: 00201001259562

Email: [email protected]

Hatem A Awaga, MD

Role: CONTACT

Phone: 00201550777310

Email: [email protected]

Facility Contacts

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Amr O Abdelkareem, MD

Role: primary

Hatem A Awaga, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21214719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29650105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16443865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29472628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26928912 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 29370047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30461693 (View on PubMed)

Other Identifiers

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Soh-Med-21-12-39

Identifier Type: -

Identifier Source: org_study_id