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

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

781 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-30

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hyperglycemia 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.

hyperglycemia exposure in the first trimester

Intervention Type OTHER

The exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation

euglycemia in the first trimester

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.

No interventions assigned to this group

Interventions

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hyperglycemia exposure in the first trimester

The exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No