Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus

NCT ID: NCT05670548

Last Updated: 2023-01-04

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

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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This project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. We intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of GDM. At the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of GDM to the outcome of abnormal glucose metabolism.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Abnormal postpartum glucose metabolism

GDM with positive OGTT results at 6-12 weeks postpartum

Questionnaire survey and specimen collection

Intervention Type OTHER

A questionnaire survey was conducted when pregnant women were enrolled, and blood were collected at 24-28 gestational weeks. Placenta and umbilical cord blood are collected during delivery.

Control

GDM with negative OGTT results at 6-12 weeks postpartum

Questionnaire survey and specimen collection

Intervention Type OTHER

A questionnaire survey was conducted when pregnant women were enrolled, and blood were collected at 24-28 gestational weeks. Placenta and umbilical cord blood are collected during delivery.

Interventions

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Questionnaire survey and specimen collection

A questionnaire survey was conducted when pregnant women were enrolled, and blood were collected at 24-28 gestational weeks. Placenta and umbilical cord blood are collected during delivery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Plan to have routine prenatal examinations and give birth in the research center
* GDM was diagnosed at 24-28 gestational weeks
* Singleton pregnancy
* Without other pregnancy complications
* Willing to cooperate with the hospital to follow up

Exclusion Criteria

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhaoxia Liang, Prof.

Role: STUDY_DIRECTOR

Women's Hospital School Of Medicine Zhejiang University

Locations

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Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoxia Liang, Prof.

Role: CONTACT

86571-89992115

Facility Contacts

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Zhaoxia Liang, Prof.

Role: primary

86571-89992115

Other Identifiers

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IRB-20220336-R

Identifier Type: -

Identifier Source: org_study_id

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