Diagnostic Analysis of Oral Glucose Tolerance Test in Early Pregnancy for Gestational Diabetes Mellitus

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: hyperglycemia exposure in the first trimester

• Registration Number: NCT05487352
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

The aim of this study is to explore the diagnostic efficacy of oral glucose tolerance test in early pregnancy and establish the prediction model for gestational diabetes mellitus, so as to provide the optimal screening of gestational diabetes mellitus in the first trimester. The treatment started when the pregnancy was confirmed by transvaginal ultrasound (around 6 weeks of gestation) and continued until 42 days postpartum. The study is a single center, prospective cohort study. A total of 781 participants within 14 weeks of gestation were recruited.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-30
• Primary Completion: 2022-05-27
• Study First Submitted: 2022-07-21
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 781

Inclusion Criteria

• 1. Intrauterine pregnancy within 7-14 weeks of gestation
• 2. 20-45 years of age
• 3. Singleton pregnancy
• 4. Giving informed consent and willing to participate in this study
• 5. Planning to give birth in Women's Hospital School of Medicine Zhejiang University

Exclusion Criteria

• 1. Pre-existing diabetes
• 2. Taking medications that may affect blood glucose levels within one month
• 3. Participating in other intervention studies
• 4. Recurrent abortion, threatened abortion, cervical incompetence or fetal malformation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hyperglycemia in the first trimester	hyperglycemia exposure in the first trimester	The 75g oral glucose tolerance test was performed before 14 weeks of gestation, and any of the fasting, 1-hour and 2-hours blood glucose was ≥ 5.1, 10.0 and 8.5 mmol/L, respectively.

Primary Outcome Measures

Name	Time	Method
gestational diabetes mellitus	24-28 weeks of gestation	any of the fasting, 1-hour and 2-hour blood glucose ≥ 5.1, 10.0, 8.5 mmol/L, respectively, in the 75g oral glucose tolerance test during 24-28 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
gestational age at delivery	through study completion, an average of 39 gestational weeks	gestational weeks at the day of delivery
neonatal weight, height and head circumference	42 days after birth	baby's weight, height and head circumference at 42 days after birth
gestational weight gain	before delivery	total weight gain from pre-pregnancy until delivery
birthweight	within 24 hours after birth	birthweight of the infant

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China