Maternal Serum Pentraxin 3 in Early Pregnancy to Predict Gestational Diabetes Mellitus

Completed

• Conditions: Pregnancy Complications Affecting Fetus (Diagnosis)
• Interventions: Diagnostic Test: 75gOGTT

• Registration Number: NCT03563638
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

To investigate the association of maternal serum concentrations of pentraxin 3 in early pregnancy with gestational diabetes mellitus and to explore its potential value in the prediction of GDM.

Detailed Description

We recruited all pregnant women for the first checkup in our hospital . Maternal fasting serum PTX3 levels, fasting plasma glucose and fasting insulin and other factors were measured. Oral glucose tolerance test (OGTT) was performed at 24-28 weeks in all participants. According to the occurrence of GDM, subjects were divided into two groups: GDM group and normal glucose tolerance (NGT) group.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2015-12-01
• Study Completion: 2015-12-01
• Study First Submitted: 2018-05-26
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-06-20
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 824

Inclusion Criteria

• Women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception were invited to participate in the study.

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Exclusion Criteria

• Women were excluded if they had multiple pregnancy, pre-gestational diabetes mellitus (PGDM), hypertensive disorders, preterm delivery, cardiovascular disease, immunological disease, glucocorticoid therapy, or other severe illness. In addition, women who were suffering from fetal abnormalities including chromosomally abnormal fetuses and/or structural defects and fetal growth restriction occurred during pregnancy were also excluded from the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM group	75gOGTT	Women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception were invited to participate in the study,and excluded if they had multiple pregnancy, pre-gestational diabetes mellitus, hypertensive disorders, preterm delivery, cardiovascular disease, immunological disease, glucocorticoid therapy, or other severe illness,and fetal abnormalities occurred during pregnancy were also excluded from the study.GDM was verified on the 75gOGTT at 24-28 gestational weeks.The diagnosis of GDM is made when any of the following plasma glucose values are met or exceeded: FPG≥5.1 mmol/L and/or 1h-PG ≥10.0 mmol/L and/or 2h-PG ≥8.5 mmol/ L.
NGT group	75gOGTT	Women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception were invited to participate in the study. Women were excluded if they had multiple pregnancy, pre-gestational diabetes mellitus (PGDM), hypertensive disorders, preterm delivery, cardiovascular disease, immunological disease, glucocorticoid therapy, or other severe illness. if there were fetal abnormalities including chromosomally abnormal fetuses and/or structural defects and fetal growth restriction occurred during pregnancy were also excluded from the study.GDM was verified on the 75gOGTT at 24-28 gestational weeks.those who not met the criteria were the NCT group.

Primary Outcome Measures

Name	Time	Method
Serum PTX3 levels in early pregnancy	2015.10.01-2015.11.31	Serum PTX3 levels in early pregnancy