Telocytes in Umbilical Cord of Pregnancies Complicated by Chronic Hypertension, Gestational Hypertension and PreeclampsiaNCT05305339
Telocytes in Umbilical Cord of Patients With and Without Pre-eclampsia
An observational study of Telocytes in Umbilical Cord of Pregnancies Complicated by Chronic Hypertension, Gestational Hypertension and Preeclampsia, run by Sohag University at 1 site in Egypt.
Trial summary
Studying the ultrastructural and immunohistochemical characteristics of Telocytes from umbilical cord vessels wall in PE patients compared to control and its relation to severity of disease whether controlled or uncontrolled. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Telocytes in Umbilical Cord of Pregnancies Complicated by Chronic Hypertension, Gestational Hypertension and Preeclampsia
- What is being tested?
- Placental and Umbilical cord biopsy
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnosis of chronic hypertension, gestational hypertension and preeclampsia preeclampsia:Women with 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). Gestational hypertension: Women with systolic blood pressure is 140 mmHg or more or a diastolic blood pressure of 90 mmHg 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. Chronic hypertension: It means systolic blood pressure of 140 mmHg or more, a diastolic blood pressure of 90 mmHg 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. Patients are finally classified to PE with severe features, PE without severe features, Gestational hypertension, chronic hypertension and chronic hypertension with superimposed PE.
Who may be able to join
- Study group Singleton pregnancies complicated with hypertension undergoing pre-labour CS at gestational age (34+0 to 40+0). These will be divided into 3 groups according to the type of disease either chronic hypertension (Group A), gestational hypertension (Group B) or preeclampsia (Group C).
- Control group Singleton pregnancies undergoing elective pre-labour CS that are otherwise healthy.
Who cannot join
- Women with history of medical co-morbidities other than hypertension were excluded from the study. This includes the following: 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 thrombocytopenia.
- Multiple pregnancies.
- Abnormal placentation, i.e. Placenta previa and Morbidly adherent placenta.
- Fetal anomalies.
- vaginal deliveries and CS in labour.
Trial locations and contacts
1 site in 1 country.
hatem awaga contact
Egypt1 site, 1 recruiting
- Recruiting
Hatem Awaga
Sohag, 82524
Hatem awaga, 01550777310, hatemaboelftooh@yahoo.com
Hatem awaga, hatemaboelftoohhassan@gmail.com
About this study
Studying the ultrastructural and immunohistochemical characteristics of Telocytes from umbilical cord vessels wall in PE patients compared to control and its relation to severity of disease whether controlled or uncontrolled.
Read the detailed description
Patients fulfilling the eligibility criteria of the current research will be approached prior to delivery. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent.
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
- 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].
- 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].
- 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).
- Being tested
- Placental and Umbilical cord biopsy
- Keywords
- Telocytes, Umbilical cord, Preeclampsia
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placental and Umbilical cord biopsyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control group) | Singleton pregnancies undergoing elective pre-labour CS at gestational age (34+0 to 40+0) that are otherwise healthy. Receives: Other: Placental and Umbilical cord biopsy | |
| 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 Receives: Other: Placental and Umbilical cord biopsy | |
| 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. Receives: Other: Placental and Umbilical cord biopsy | |
| 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 Receives: Other: Placental and Umbilical cord biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telocytes in placenta and umbilical cord
The number and distribution of Telocytes by immunohistochemistry in placenta and umbilical cord vessels wall.
Measured: Immediately after delivery of the placenta during cesarian section of pregnancies with gestational age (34-40) weeks
Secondary outcomes (1)
Telocytes Morphology in relation to disease severity
Characterization of telocyte morphology using electron microscopy, comparing umbilical artery indices in different groups and its correlation to abundance of telocytes in examined tissues.
Measured: Immediately after delivery of the placenta during cesarian section of pregnancies with gestational age (34-40) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Feb 2022
- Primary completion20 Feb 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telocytes in Umbilical Cord of Pregnancies Complicated by Chronic Hypertension, Gestational Hypertension and PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Awaga, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305339
- Sponsor's protocol ID
- Soh-Med-21-12-44
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telocytes in Umbilical Cord of Patients With and Without Pre-eclampsia
- ClinicalTrials.gov ID
- NCT05305339
- Acronym / sponsor ID
- Soh-Med-21-12-44
- Keywords
- Telocytes, Umbilical cord, Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying the ultrastructural and immunohistochemical characteristics of Telocytes from umbilical cord vessels wall in PE patients compared to control and its relation to severity of disease whether controlled or uncontrolled.
Detailed description
Patients fulfilling the eligibility criteria of the current research will be approached prior to delivery. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent.
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
- 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].
- 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].
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (Control group) | – | Other: Placental and Umbilical cord biopsySingleton pregnancies undergoing elective pre-labour CS at gestational age (34+0 to 40+0) that are otherwise healthy. |
| Group B (Chronic hypertension) | – | Other: Placental and Umbilical cord biopsyIt 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 |
| Group C (Gestational hypertension) | – | Other: Placental and Umbilical cord biopsyIt 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. |
| Group D (Preeclampsia) | – | Other: Placental and Umbilical cord biopsyWomen 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis of chronic hypertension, gestational hypertension and preeclampsia preeclampsia:Women with 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). Gestational hypertension: Women with systolic blood pressure is 140 mmHg or more or a diastolic blood pressure of 90 mmHg 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. Chronic hypertension: It means systolic blood pressure of 140 mmHg or more, a diastolic blood pressure of 90 mmHg 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. Patients are finally classified to PE with severe features, PE without severe features, Gestational hypertension, chronic hypertension and chronic hypertension with superimposed PE.
Key inclusion criteria (2 listed)
- Study group Singleton pregnancies complicated with hypertension undergoing pre-labour CS at gestational age (34+0 to 40+0). These will be divided into 3 groups according to the type of disease either chronic hypertension (Group A), gestational hypertension (Group B) or preeclampsia (Group C).
- Control group Singleton pregnancies undergoing elective pre-labour CS that are otherwise healthy.
Key exclusion criteria (6 listed)
- Women with history of medical co-morbidities other than hypertension were excluded from the study. This includes the following: 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 thrombocytopenia.
- Multiple pregnancies.
- Abnormal placentation, i.e. Placenta previa and Morbidly adherent placenta.
- Fetal anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placental and Umbilical cord biopsyAfter 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). | Other | Group A (Control group), Group B (Chronic hypertension), Group C (Gestational hypertension), Group D (Preeclampsia) |
Primary outcome
Telocytes in placenta and umbilical cord
Time frame: Immediately after delivery of the placenta during cesarian section of pregnancies with gestational age (34-40) weeks
The number and distribution of Telocytes by immunohistochemistry in placenta and umbilical cord vessels wall.
1 secondary outcome
Telocytes Morphology in relation to disease severity
Time frame: Immediately after delivery of the placenta during cesarian section of pregnancies with gestational age (34-40) weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hatem awaga contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telocytes in Umbilical Cord of Pregnancies Complicated by Chronic Hypertension, Gestational Hypertension and Preeclampsia, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hatem awaga, Lecturer (01550777310, hatemaboelftooh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telocytes in placenta and umbilical cord (time frame: Immediately after delivery of the placenta during cesarian section of pregnancies with gestational age (34-40) weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.