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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03563638
Other study ID # Quxiaoxian
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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