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

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ClinicalTrials.gov Identifier: NCT03563638
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pregnancy Complications Affecting Fetus (Diagnosis) 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
Actual Enrollment : 824 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Maternal Serum Pentraxin 3 in Early Pregnancy to Predict Gestational Diabetes Mellitus
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 1, 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Serum PTX3 levels in early pregnancy [ Time Frame: 2015.10.01-2015.11.31 ]
    Serum PTX3 levels in early pregnancy



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Ages Eligible for Study:   27 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT03563638     History of Changes
Other Study ID Numbers: Quxiaoxian
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Pregnancy Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases