Diabetes in PregnancyNCT05305326
Telocytes in Placental Tissues of Patients With Gestational and Pre-gestational Diabetes
An observational study of Diabetes in Pregnancy, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes in Pregnancy
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 31 Dec 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag, 82514
Amr O Abdelkareem, MD, 00201001259562, amr.oth@med.sohag.edu.eg
Hatem A Awaga, MD, 00201550777310, hatemaboelftooh@yahoo.com
About this study
Examining the expression of telocytes in the placental tissues and umbilical cord of patients with gestational or pregestational diabetes during pregnancy compared to control.
Read the detailed description
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
- Diabetes in Pregnancy
- Keywords
- pregnancy, diabetes, telocytes, placenta, umbilical cord
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telocytes
number of telocytes per high power field detected by IHC
Measured: Telocytes will be assessed in placental and umbilical cord tissues fixed immediately after delivery.
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 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes in PregnancyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Othman Abdelkareem Mohammad Ahmad, Sohag University
- Investigators
- Amr O Abdelkareem, MD, Principal investigator, Sohag Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305326
- Sponsor's protocol ID
- Soh-Med-21-12-39
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on personal request de-identified IPD could be shared in the form of Telocytes score of placenta and cord and statistical analysis done.
Publications
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.
PubMed 21214719Diabetes 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.
PubMed 29650105Feig 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.
PubMed 16443865Nizyaeva 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.
PubMed 29472628Chamberlain 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.
PubMed 26928912ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047American 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.
PubMed 30461693
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 Placental Tissues of Patients With Gestational and Pre-gestational Diabetes
- ClinicalTrials.gov ID
- NCT05305326
- Acronym / sponsor ID
- Soh-Med-21-12-39
- Conditions
- Diabetes in Pregnancy
- Keywords
- pregnancy, diabetes, telocytes, placenta, umbilical cord
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- All pregnant women presented at the delivery ward in Sohag University Hospital, Sohag, Egypt with the following criteria:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Telocytes
Time frame: Telocytes will be assessed in placental and umbilical cord tissues fixed immediately after delivery.
number of telocytes per high power field detected by IHC
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.
- Background: PubMed 21214719Blanco 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.
- Background: PubMed 29650105Diabetes 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.
- Background: PubMed 16443865Feig 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.
- Background: PubMed 29472628Nizyaeva 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.
- Background: PubMed 26928912Chamberlain 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.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Background: PubMed 30461693American 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.
- Individual participant dataSharing planned: Yes. on personal request de-identified IPD could be shared in the form of Telocytes score of placenta and cord and statistical analysis done.
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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.
Amr O Abdelkareem, MD principal investigator
Sohag Faculty of Medicine
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 Diabetes in Pregnancy, 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 7 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 Amr O Abdelkareem, MD (00201001259562, amr.oth@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telocytes (time frame: Telocytes will be assessed in placental and umbilical cord tissues fixed immediately after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305326, which also lists 7 linked publications.
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.