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

NCT04858386 | Terminated

• 1 other identifier: 17024UG-SW
• Study Type: observational
• Target: 1,314
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HbA1c; Fetal Growth; Macrosomia; Visceral Fat; Pregnancy; Glucose Intolerance

Outcome Measures

Primary Outcomes (2)

• Excessive Fetal Growth

  Estimated Fetal Weight ≥90th centile

  28 weeks gestation

• Excessive Fetal Growth

  Fetal Abdominal Circumference \>90th centile

  28 weeks gestation

Secondary Outcomes (2)

• Gestational Diabetes

  28 weeks gestation

• Adverse Pregnancy Outcomes

  Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women at risk of glucose intolerance/gestational diabetes

You may qualify if:

• Age ≥ 18yrs, and at least one of the following NICE risk factors for glucose intolerance:
• body mass index ≥ 30kg/m2 a family history of diabetes (first-degree relative) previous macrosomic baby (\>4.5kg) minority ethnic family origin with a high prevalence of diabetes

You may not qualify if:

• \- pre-existing type 1 or type 2 diabetes mellitus, a previous history of GDM, booking HbA1c ≥ 48mmol/mol (6.5%), anaemia diagnosed on booking full blood count, booking diagnosis of a multiple pregnancy, use of corticosteroids or metformin within 12 weeks of booking

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Queen's University, Belfast: collaborator

Study Sites (1)

Royal Jubilee Maternity Service

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen Serum Frozen Plasma Frozen centrifuged urine

MeSH Terms

Conditions

Diabetes, Gestational; Glucose Intolerance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Una Graham, MB BCh BAO

  Belfast Health & Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: November 1, 2017
• Primary Completion: March 21, 2020
• Study Completion: August 4, 2020
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

GB (1)