PAPP-A and HbA1c in first trimester and Gestational Diabetes

• Research type

  Research Study

• Full title

  Prediction of Gestational Diabetes by measuring serum pregnancy associated protein-A (PAPP-A) and HbA1c in the first trimester of pregnancy

• IRAS ID

  332778

• Contact name

  Emily Leach

• Contact email

  emily.leach@nnuh.nhs.uk

• Sponsor organisation

  Norfolk and Norwich University Hospital

• Duration of Study in the UK

  0 years, 5 months, 3 days

• Research summary

  Glossary of terms
  Gestation - the time between conception and birth.
  Glycosuria - glucose (sugar) in urine.
  PAPP-A - Pregnancy associated plasma protein-A.
  

  This is a retrospective cohort study. First trimester and 24-28-week data related to pregnant women will be retrieved from the Laboratory Information Management System (LIMS) and Lifecycle database at the Norfolk and Norwich University Hospital (NNUH). A logistic model will be used to analyse the association between first trimester PAPP-A and HbA1c and subsequent glucose tolerance test results or Glucose and HbA1c performed between 24-28 weeks’ gestation.

  Only pregnant women with the following risk factors were offered first trimester HbA1c and follow up oral glucose tolerance test (OGTT) at between 24 and 28 weeks’ gestation:
  • Susceptible ethnic group
  • An episode of glycosuria
  • A previous baby weighing over 4.5kg
  • A body mass index (BMI) of over 30 (clinically obese)
  • A family history of diabetes

  Only pregnant women with one or more of the above risk factors, within the ‘at risk of GDM’ group, will be included in this study. Pregnant women with pre-existing diabetes type 1 or type 2 will be excluded from the data analysed.
  The patients will be split into two groups, those with low PAPP-A (less than 0.4 MoM) will be defined as the ‘exposure group’ and those with ‘normal’ PAPP-As will be defined as the ‘non-exposure group. HbA1c and OGTT results will be compared in the two groups to determine if patients with low PAPP-A have increased HbA1c at booking and if they have increased risk of GDM.

  The objectives of the project are as follows:

  Primary objectives

  • To determine if pregnant patients with low PAPP-A between 11-14 weeks’ gestation have an increased risk of developing GDM.

  • To determine if there is a correlation between first trimester PAPP-A results and first trimester HbA1c results.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  23/PR/1218

• Date of REC Opinion

  26 Oct 2023

• REC opinion

  Favourable Opinion