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

Women's Hospital School Of Medicine Zhejiang University

Status: Active, not recruiting

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Other: hyperglycemia exposure in the first trimester

Study type: Observational

Funder types: Other

Identifiers

NCT05487352

IRB-20210134-R

Details and patient eligibility

About

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.

Enrollment: 781 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

781 participants in 2 patient groups

hyperglycemia in the first trimester

Description:

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.

Treatment:

Other: hyperglycemia exposure in the first trimester

euglycemia in the first trimester

Description:

The 75g oral glucose tolerance test was performed before 14 weeks of gestation, and the fasting, 1-hour and 2-hours blood glucose were all \< 5.1, 10.0 and 8.5 mmol/L, respectively.