MedTrace Logo

The Use of Early Pregnancy HbA1c in Predicting Excessive Fetal Growth in Women at Risk of Glucose Intolerance

NCT04858386 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1314

Last updated 2021-04-26

No results posted yet for this study

Summary

The association of hyperglycaemia in pregnancy (gestational diabetes mellitus; GDM) with adverse maternal and fetal outcomes is clearly recognised. Traditionally the diagnosis is made at 28 weeks gestation at which stage children of affected women already have a two-fold rate of excessive weight gain (abdominal circumference \> 90th percentile). This is attributed to fetal exposure to undiagnosed high blood glucose earlier in pregnancy. Indeed almost 25% of women with GDM develop the condition before 20 weeks gestation. Interventional studies in women diagnosed in the late second trimester have shown benefits in reducing fetal macrosomia. It is unknown whether screening in the first trimester would predict fetal macrosomia and allow more timely and effective intervention. To examine this question, we propose a prospective cohort study of 1,662 women at increased risk of GDM to determine if an elevated HbA1c (39-48mmool/l) in early pregnancy (\<14 weeks) can identify babies at risk of excessive weight gain in later pregnancy, as determined by ultrasound measurement of abdominal circumference at 28 weeks gestation. The study will be largely integrated into routine clinical practice enabling a large number of women to participate. Study participants will all undergo formal screening (75g oral glucose tolerance test) for GDM at 28 weeks gestation. Secondary outcomes, namely the ability of early pregnancy HbA1c to predict later maternal GDM, and fetal and maternal complications of pregnancy will also be evaluated. The results of this study, if positive, are likely to impact upon patient care almost immediately following study completion. In addition, given the stability of the Northern Ireland population, the relatively unique data set will facilitate future work on predictive markers for cardiovascular disease, and prospective studies on the cardiovascular consequences of GDM on both mother and baby.

Conditions

  • Gestational Diabetes

Sponsors & Collaborators

  • Queen's University, Belfast

    collaborator OTHER

  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • Una Graham, MB BCh BAO · Belfast Health & Social Care Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-03-21
Completion
2020-08-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858386 on ClinicalTrials.gov