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

Pregnancy Complications Affecting Fetus (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563638
• Other study ID #: Quxiaoxian
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: December 1, 2015

Study information

• Verified date: June 2018
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 27 Years to 33 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Pregnancy Complications
• Pregnancy Complications Affecting Fetus (Diagnosis)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PTX3 levels in early pregnancy	Serum PTX3 levels in early pregnancy	2015.10.01-2015.11.31