Telocytes in Umbilical Cord of Patients With and Without Pre-eclampsia
NCT ID: NCT05305339
Last Updated: 2022-03-31
Study Results
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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UNKNOWN
40 participants
OBSERVATIONAL
2022-02-01
2023-04-30
Brief Summary
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Detailed Description
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Routine investigations will be performed to all patients including CBC, liver and renal function and urine analysis in addition to albumin creatinine ratio.
Ultrasound scanning including umbilical doppler indices measurement will be done for all cases before delivery using an HDI ultrasound system (AlbiniouTL Ultrasound, Bothell, WA, USA).
Non stress test is routinely done for all hypertensive patients twice weekly as part of routine work up of such patients in our emergency unit using (CTG machine-NSL BT-350 Bistos) (Korea).
Diagnosis of chronic hypertension, gestational hypertension and preeclampsia
1. preeclampsia: Women with PE fulfilled the criteria if they had hypertension (\> 140/90 mmHg) and proteinuria (\> 0.3 gm/day or ≥ +1 by dipstick urine analysis at ≥ 20 weeks of gestation or protein-to-creatinine ratio of 0.30 or more). If no proteinuria, hypertension associated with thrombocytopenia, renal or liver impairment, or pulmonary edema was sufficient to diagnose PE as per ACOG Practice Bulletin No .202\[6\].
2. Gestational hypertension:
It is usually diagnosed when systolic blood pressure is 140 mm Hg or more or a diastolic blood pressure of 90 mm Hg or more, or both, on two occasions at least 4 hours apart after 20 weeks of gestation, in a woman with a previously normal blood pressure \[7\]. Gestational hypertension is considered severe when the systolic level reaches 160 mm Hg or the diastolic level reaches 110 mm Hg, or both \[6\].
3. Chronic hypertension:
It means systolic blood pressure of 140 mm Hg or more, a diastolic blood pressure of 90 mm Hg or more, or both, that is diagnosed or present before pregnancy or before 20 weeks of gestation on two occasions at least 4 hours apart. Hypertension that is diagnosed for the first-time during pregnancy and that does not resolve in the typical postpartum period also is classified as chronic hypertension\[8\].
Patients are finally classified to PE with severe features, PE without severe features, Gestational hypertension (mild and severe), chronic hypertension and chronic hypertension with superimposed PE and termination will be done according to the recent recommendation of ACOG \[6, 8\].
Tissue and samples procurement and processing:
Specimen preparation After delivery of the placenta, two tissue fragments, 1st piece about 1x1 cm from the central zone of the maternal surface of the placenta and 2nd piece about 1 x 1 cm from mid segment of umbilical cord will be cut. Each of both samples will be divided and fixed in either a 10% formalin for light microscopic examination or glutaraldehyde 2.5% for Electron microscopic examination. Paraffin-embedded placental tissue sections (4 μm thick) will be used for histological (stained with hematoxylin and eosin) and immunohistochemical examination using primary antibody markers for telocytes CD117, CD34, vimentin, SMA (smooth muscle actin), and the new telocyte marker TMEM16a (DOG-1).
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group A (Control group)
Singleton pregnancies undergoing elective pre-labour CS at gestational age (34+0 to 40+0) that are otherwise healthy.
Placental and Umbilical cord biopsy
After delivery of the placenta, two tissue fragments, 1st piece about 1x1 cm from the central zone of the maternal surface of the placenta and 2nd piece about 1 x 1 cm from mid segment of umbilical cord will be cut. Each of both samples will be divided and fixed in either a 10% formalin for light microscopic examination or glutaraldehyde 2.5% for Electron microscopic examination. Paraffin-embedded placental tissue sections (4 μm thick) will be used for histological (stained with hematoxylin and eosin) and immunohistochemical examination using primary antibody markers for telocytes CD117, CD34, vimentin, SMA (smooth muscle actin), and the new telocyte marker TMEM16a (DOG-1).
Group B (Chronic hypertension)
It means systolic blood pressure of 140 mm Hg or more, a diastolic blood pressure of 90 mm Hg or more, or both, that is diagnosed or present before pregnancy or before 20 weeks of gestation on two occasions at least 4 hours apart. Hypertension that is diagnosed for the first-time during pregnancy and that does not resolve in the typical postpartum period also is classified as chronic hypertension
Placental and Umbilical cord biopsy
After delivery of the placenta, two tissue fragments, 1st piece about 1x1 cm from the central zone of the maternal surface of the placenta and 2nd piece about 1 x 1 cm from mid segment of umbilical cord will be cut. Each of both samples will be divided and fixed in either a 10% formalin for light microscopic examination or glutaraldehyde 2.5% for Electron microscopic examination. Paraffin-embedded placental tissue sections (4 μm thick) will be used for histological (stained with hematoxylin and eosin) and immunohistochemical examination using primary antibody markers for telocytes CD117, CD34, vimentin, SMA (smooth muscle actin), and the new telocyte marker TMEM16a (DOG-1).
Group C (Gestational hypertension)
It is usually diagnosed when systolic blood pressure is 140 mm Hg or more or a diastolic blood pressure of 90 mm Hg or more, or both, on two occasions at least 4 hours apart after 20 weeks of gestation, in a woman with a previously normal blood pressure. Gestational hypertension is considered severe when the systolic level reaches 160 mm Hg or the diastolic level reaches 110 mm Hg or both.
Placental and Umbilical cord biopsy
After delivery of the placenta, two tissue fragments, 1st piece about 1x1 cm from the central zone of the maternal surface of the placenta and 2nd piece about 1 x 1 cm from mid segment of umbilical cord will be cut. Each of both samples will be divided and fixed in either a 10% formalin for light microscopic examination or glutaraldehyde 2.5% for Electron microscopic examination. Paraffin-embedded placental tissue sections (4 μm thick) will be used for histological (stained with hematoxylin and eosin) and immunohistochemical examination using primary antibody markers for telocytes CD117, CD34, vimentin, SMA (smooth muscle actin), and the new telocyte marker TMEM16a (DOG-1).
Group D (Preeclampsia)
Women with PE fulfilled the criteria if they had hypertension (\> 140/90 mmHg) and proteinuria (\> 0.3 gm/day or ≥ +1 by dipstick urine analysis at ≥ 20 weeks of gestation or protein-to-creatinine ratio of 0.30 or more). If no proteinuria, hypertension associated with thrombocytopenia, renal or liver impairment, or pulmonary edema was sufficient to diagnose PE as per ACOG Practice Bulletin No .202
Placental and Umbilical cord biopsy
After delivery of the placenta, two tissue fragments, 1st piece about 1x1 cm from the central zone of the maternal surface of the placenta and 2nd piece about 1 x 1 cm from mid segment of umbilical cord will be cut. Each of both samples will be divided and fixed in either a 10% formalin for light microscopic examination or glutaraldehyde 2.5% for Electron microscopic examination. Paraffin-embedded placental tissue sections (4 μm thick) will be used for histological (stained with hematoxylin and eosin) and immunohistochemical examination using primary antibody markers for telocytes CD117, CD34, vimentin, SMA (smooth muscle actin), and the new telocyte marker TMEM16a (DOG-1).
Interventions
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Placental and Umbilical cord biopsy
After delivery of the placenta, two tissue fragments, 1st piece about 1x1 cm from the central zone of the maternal surface of the placenta and 2nd piece about 1 x 1 cm from mid segment of umbilical cord will be cut. Each of both samples will be divided and fixed in either a 10% formalin for light microscopic examination or glutaraldehyde 2.5% for Electron microscopic examination. Paraffin-embedded placental tissue sections (4 μm thick) will be used for histological (stained with hematoxylin and eosin) and immunohistochemical examination using primary antibody markers for telocytes CD117, CD34, vimentin, SMA (smooth muscle actin), and the new telocyte marker TMEM16a (DOG-1).
Eligibility Criteria
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Inclusion Criteria
2. Control group Singleton pregnancies undergoing elective pre-labour CS that are otherwise healthy.
Exclusion Criteria
* Pregnancy induced medical disorders like: Gestational thrombocytopenia.
* Multiple pregnancies.
* Abnormal placentation, i.e. Placenta previa and Morbidly adherent placenta.
* Fetal anomalies.
* vaginal deliveries and CS in labour.
FEMALE
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Hatem Awaga
Lecturer of Obstetrics and Gynecology
Locations
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Hatem Awaga
Sohag, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Hatem awaga
Role: primary
Hatem awaga
Role: backup
Other Identifiers
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Soh-Med-21-12-44
Identifier Type: -
Identifier Source: org_study_id