Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy

NCT ID: NCT06064552

Last Updated: 2023-10-03

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-24

Study Completion Date

2024-09-24

Brief Summary

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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.

Detailed Description

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Conditions

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Screening for Hyperglycemia in First Trimester in High and Low Risk Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

blood sugar

Intervention Type DIAGNOSTIC_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

low risk pregnancy

average risk population like primigravida healthy women or those with normal obstetric history.

blood sugar

Intervention Type DIAGNOSTIC_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

Interventions

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blood sugar

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* • 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Amira Ahmed Mohamed

resident at obstetric and gynacology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amira A Mohammed, resident

Role: CONTACT

01152910731

osman A Mohammed, professor

Role: CONTACT

01116239995

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25388922 (View on PubMed)

Hadden 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.

Reference Type BACKGROUND
PMID: 18986856 (View on PubMed)

Auvinen 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.

Reference Type BACKGROUND
PMID: 32725280 (View on PubMed)

Other Identifiers

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soh-Med-23-09-04MS

Identifier Type: -

Identifier Source: org_study_id

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