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

Diagnostic Efficiency Analysis of Oral Glucose Tolerance Test and Prediction Model Establishment in the First Trimester for Gestational Diabetes Mellitus: a Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05487352
Enrollment
781
Registered
2022-08-04
Start date
2021-05-30
Completion date
2022-10-31
Last updated
2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

gestational diabetes mellitus, first trimester, prediction model

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.

Interventions

OTHERhyperglycemia exposure in the first trimester

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

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frameDescription
gestational diabetes mellitus24-28 weeks of gestationany 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

MeasureTime frameDescription
gestational weight gainbefore deliverytotal weight gain from pre-pregnancy until delivery
gestational age at deliverythrough study completion, an average of 39 gestational weeksgestational weeks at the day of delivery
birthweightwithin 24 hours after birthbirthweight of the infant
neonatal weight, height and head circumference42 days after birthbaby's weight, height and head circumference at 42 days after birth

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026