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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06064552
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

Brief 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 . 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: blood sugar

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy
Actual Study Start Date :
Sep 24, 2023
Anticipated Primary Completion Date :
Sep 24, 2024
Anticipated Study Completion Date :
Sep 24, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. blood sugar percentage [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt Sohag

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amira Ahmed Mohamed, resident at obstetric and gynacology department, Sohag University
ClinicalTrials.gov Identifier:
NCT06064552
Other Study ID Numbers:
  • soh-Med-23-09-04MS
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023