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

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 Overview

• Status: Recruiting
• Conditions: Screening for Hyperglycemia in First Trimester in High and Low Risk Pregnancy
• Intervention / Treatment: Diagnostic test: blood sugar

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Amira A Mohammed, resident; Phone Number: 01152910731; Email: amiraahmed@med.sohag.edu.eg
• Study Contact Backup: Name: osman A Mohammed, professor; Phone Number: 01116239995

Study Locations

• Egypt
  • Sohag, Egypt, Sohag
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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.

Exclusion Criteria:

• all patient not have thev inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 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
low risk pregnancy; average risk population like primigravida healthy women or those with normal obstetric history.	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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. Erratum In: Semin Fetal Neonatal Med. 2009 Dec;14(6):401.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Estimated): September 24, 2024
• Study Completion (Estimated): September 24, 2024

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: soh-Med-23-09-04MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No