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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications Affecting Fetus (Diagnosis)
• Intervention / Treatment: Diagnostic test: 75gOGTT

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 Type: Observational
• Enrollment (Actual): 824

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 33 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

chinese women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception

Description

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GDM group; 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.	Diagnostic test: 75gOGTT; oral glucose tolerance test (OGTT) was conducted on all participants between the 24th and 28th gestation 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; 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.	Diagnostic test: 75gOGTT; oral glucose tolerance test (OGTT) was conducted on all participants between the 24th and 28th gestation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum PTX3 levels in early pregnancy	Serum PTX3 levels in early pregnancy	2015.10.01-2015.11.31

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 26, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: Quxiaoxian

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No