Screening for Hyperglycemia in First Trimester in High and Low Risk PregnancyNCT06064552
Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy
An observational study of Screening for Hyperglycemia in First Trimester in High and Low Risk Pregnancy, run by Sohag University at 1 site in Egypt.
Trial summary
Glucose intolerance is the commonest medical disorder complicating pregnancy. Hyperglycemia increases the risk of delivering a large for gestational age newborn (LGA) and related complications such as operative delivery, birth trauma and the poor adaptation of the newborn . Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Screening for Hyperglycemia in First Trimester in High and Low Risk Pregnancy
- What is being tested?
- blood sugar
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2023to 24 Sep 2024
- 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: History of gestational diabetes in previous pregnancies * Polycystic ovaries syndrome * History of Macrosomic baby in previous pregnancies * Past history of late third trimester fetal demise * Past history of polyhydramnios * Overweight /Obese women Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders Multi fetal pregnancies Past history of shoulder dystocia Past history of preeclampsia Family history of diabetes In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.
Who may be able to join
- • History of gestational diabetes in previous pregnancies
- Polycystic ovaries syndrome
- History of Macrosomic baby in previous pregnancies
- Past history of late third trimester fetal demise
- Past history of polyhydramnios
- Overweight /Obese women Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders Multi fetal pregnancies Past history of shoulder dystocia Past history of preeclampsia Family history of diabetes
- In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.
Who cannot join
- all patient not have thev inclusion criteria
Trial locations and contacts
1 site in 1 country.
osman A Mohammed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
Glucose intolerance is the commonest medical disorder complicating pregnancy. Hyperglycemia increases the risk of delivering a large for gestational age newborn (LGA) and related complications such as operative delivery, birth trauma and the poor adaptation of the newborn . Maternal risks of GDM include also polyhydramnios, preeclampsia, premature delivery, prolonged labor, uterine atony, postpartum hemorrhage, infection and progression of retinopathy which are the leading global causes of maternal morbidity and mortality .Detection of women at higher risk for GDM early in pregnancy is a desirable goal because interventions such as diet, medication, and exercise may be applied earlier in pregnancy and potentially can reduce later development of GDM or its associated morbidities. Most GDM cases are diagnosed after mid-gestation following an abnormal glucose challenge test (GCT). However, about 10% of patients with GDM can be diagnosed in the first trimester.
- Being tested
- blood sugar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sugarDiagnostic test
High and low risk women will undergo measuring fasting blood sugar after fasting 6-8hours with good hydration. then measuring blood sugar 1hrs and 2hrs postprandial. for patient with high results (FBS>95mg/dl, 1hr postprandial>126mg/dl, 2hrs postprandial >140mg/dl) should do HA1C if >5.6 consider it diabetic and dealing with whom positive as regard lifestyle management like diet and exercise 150 min. per week and whom not well controlled will be enrolled in pharmacological regimen as metformin.
For whom measures normal will be tested by the same method at 20- 24 wks of gestation
| Study group | Role | What they receive |
|---|---|---|
| high risk pregnancy | Pregnant women with history of gestational diabetes in previous pregnancies, Polycystic ovaries syndrome, history of Macrosomic baby in previous pregnancies, Past history of late third trimester fetal demise, Past history of polyhydramnios, Overweight /Obese women, Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders, multi fetal pregnancies, Past history of shoulder dystocia, Past history of preeclampsia Receives: Diagnostic Test: blood sugar | |
| low risk pregnancy | average risk population like primigravida healthy women or those with normal obstetric history. Receives: Diagnostic Test: blood sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar percentage
High and low risk women will undergo measuring fasting blood sugar after fasting 6-8hours with good hydration. then measuring blood sugar 1hrs and 2hrs postprandial. for patient with high results (FBS>95mg/dl, 1hr postprandial>126mg/dl, 2hrs postprandial >140mg/dl)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start24 Sep 2023
- Primary completion24 Sep 2024 (estimated)
- Study completion24 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Screening for Hyperglycemia in First Trimester in High and Low Risk PregnancyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ahmed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064552
- Sponsor's protocol ID
- soh-Med-23-09-04MS
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He XJ, Qin FY, Hu CL, Zhu M, Tian CQ, Li L. Is gestational diabetes mellitus an independent risk factor for macrosomia: a meta-analysis? Arch Gynecol Obstet. 2015 Apr;291(4):729-35. doi: 10.1007/s00404-014-3545-5. Epub 2014 Nov 12.
PubMed 25388922Hadden DR, McLaughlin C. Normal and abnormal maternal metabolism during pregnancy. Semin Fetal Neonatal Med. 2009 Apr;14(2):66-71. doi: 10.1016/j.siny.2008.09.004. Epub 2008 Nov 4.
PubMed 18986856Auvinen AM, Luiro K, Jokelainen J, Jarvela I, Knip M, Auvinen J, Tapanainen JS. Type 1 and type 2 diabetes after gestational diabetes: a 23 year cohort study. Diabetologia. 2020 Oct;63(10):2123-2128. doi: 10.1007/s00125-020-05215-3. Epub 2020 Jul 29.
PubMed 32725280
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy
- ClinicalTrials.gov ID
- NCT06064552
- Acronym / sponsor ID
- soh-Med-23-09-04MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 24 Sep 2024 (estimated)
- First posted
- 3 Oct 2023 (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.
Glucose intolerance is the commonest medical disorder complicating pregnancy. Hyperglycemia increases the risk of delivering a large for gestational age newborn (LGA) and related complications such as operative delivery, birth trauma and the poor adaptation of the newborn . Maternal risks of GDM include also polyhydramnios, preeclampsia, premature delivery, prolonged labor, uterine atony, postpartum hemorrhage, infection and progression of retinopathy which are the leading global causes of maternal morbidity and mortality .Detection of women at higher risk for GDM early in pregnancy is a desirable goal because interventions such as diet, medication, and exercise may be applied earlier in pregnancy and potentially can reduce later development of GDM or its associated morbidities. Most GDM cases are diagnosed after mid-gestation following an abnormal glucose challenge test (GCT). However, about 10% of patients with GDM can be diagnosed in the first trimester.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high risk pregnancy | – | Diagnostic Test: blood sugarPregnant women with history of gestational diabetes in previous pregnancies, Polycystic ovaries syndrome, history of Macrosomic baby in previous pregnancies, Past history of late third trimester fetal demise, Past history of polyhydramnios, Overweight /Obese women, Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders, multi fetal pregnancies, Past history of shoulder dystocia, Past history of preeclampsia |
| low risk pregnancy | – | Diagnostic Test: blood sugaraverage risk population like primigravida healthy women or those with normal obstetric history. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- History of gestational diabetes in previous pregnancies * Polycystic ovaries syndrome * History of Macrosomic baby in previous pregnancies * Past history of late third trimester fetal demise * Past history of polyhydramnios * Overweight /Obese women Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders Multi fetal pregnancies Past history of shoulder dystocia Past history of preeclampsia Family history of diabetes In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.
Key inclusion criteria (7 listed)
- • History of gestational diabetes in previous pregnancies
- In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.
Key exclusion criteria (1 listed)
- all patient not have thev inclusion criteria
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 |
|---|---|---|
| blood sugarHigh and low risk women will undergo measuring fasting blood sugar after fasting 6-8hours with good hydration. then measuring blood sugar 1hrs and 2hrs postprandial. for patient with high results (FBS>95mg/dl, 1hr postprandial>126mg/dl, 2hrs postprandial >140mg/dl) should do HA1C if >5.6 consider it diabetic and dealing with whom positive as regard lifestyle management like diet and exercise 150 min. per week and whom not well controlled will be enrolled in pharmacological regimen as metformin. For whom measures normal will be tested by the same method at 20- 24 wks of gestation | Diagnostic test | high risk pregnancy, low risk pregnancy |
Primary outcome
blood sugar percentage
Time frame: 1 year
High and low risk women will undergo measuring fasting blood sugar after fasting 6-8hours with good hydration. then measuring blood sugar 1hrs and 2hrs postprandial. for patient with high results (FBS>95mg/dl, 1hr postprandial>126mg/dl, 2hrs postprandial >140mg/dl)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 25388922He XJ, Qin FY, Hu CL, Zhu M, Tian CQ, Li L. Is gestational diabetes mellitus an independent risk factor for macrosomia: a meta-analysis? Arch Gynecol Obstet. 2015 Apr;291(4):729-35. doi: 10.1007/s00404-014-3545-5. Epub 2014 Nov 12.
- Background: PubMed 18986856Hadden DR, McLaughlin C. Normal and abnormal maternal metabolism during pregnancy. Semin Fetal Neonatal Med. 2009 Apr;14(2):66-71. doi: 10.1016/j.siny.2008.09.004. Epub 2008 Nov 4.
- Background: PubMed 32725280Auvinen AM, Luiro K, Jokelainen J, Jarvela I, Knip M, Auvinen J, Tapanainen JS. Type 1 and type 2 diabetes after gestational diabetes: a 23 year cohort study. Diabetologia. 2020 Oct;63(10):2123-2128. doi: 10.1007/s00125-020-05215-3. Epub 2020 Jul 29.
- 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.
osman A Mohammed, professor 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 Screening for Hyperglycemia in First Trimester in High and Low Risk 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 7 inclusion and 1 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 3 Oct 2023. 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 Amira A Mohammed, resident (01152910731, amiraahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sugar percentage (time frame: 1 year). 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 NCT06064552, which also lists 3 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 3 Oct 2023.