Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes
NCT Number: NCT06545227
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Complications|Gestational Diabetes
Interventions: DEVICE: continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group.|OTHER: Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25)|OTHER: Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25)|OTHER: Maternal and neonatal outcome data collection for all women in the study
Sponsor: Imperial College London
Collaborators: Bold insight|DexCom, Inc.
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-20
Completion Date: 2026-12-31
Locations: Chelsea and Westminster Trust, London, SW10 9NH, United Kingdom

Summary:
The goal of this study investigate if pregnant women with a history of gestational diabetes (GDM) have better pregnancy outcomes if they test their blood glucose four times a day early in the pregnancy versus having an oral glucose tolerance test later in the pregnancy at 28 weeks in their current pregnancy.

Population being studied:

All pregnant women who had a history of GDM in a previous pregnancy

Study groups:

1. Women who are being managed in the pregnancy with early blood glucose monitoring (early monitoring group)
2. Women who are being managed with an oral glucose tolerance test at 28-32 weeks (late monitoring group)

This study has two parts (i) observational and (ii) mechanistic or laboratory based.

In the observational part of the study, data will be collected as standard of care across different obstetric units and this data will be used to:

1. compare the outcomes of the women such as need for labour to be induced, caesarean section rates, blood loss, need for treatment of their blood glucose with metformin or insulin, HbA1c values
2. compare the outcomes of the offspring such as birth weight centiles, shoulder dystocia or birth trauma, hypoglycaemia, jaundice and if admitted to the neonatal unit.

The mechanistic or laboratory part of the study is aimed at studying how the two different treatment approaches affect:

1. the metabolome of the pregnant woman - urine and blood samples collected at two time points will be used and mass spectrometry used to determine the amino acid and lipid profiles.
2. the microbiome differs between both groups
3. the pathways that regulate insulin in the placenta
4. the ability of the cells in the umbilical cord differentiate into the different fat cells.

Primary Outcome Measures: Comparison of the maternal metabolome between the early monitoring group and the late monitoring group., Mass spectrometry will be used to study and analyse roughly 200 aqueous metabolites from glycolysis, TCA cycle, amino acid metabolism, nucleotides, beta-oxidation and the pentose phosphate pathway, with quantification against stable isotope labelled standards, 12 months|Comparison of the cord blood DNA methylation between the early monitoring group and the late monitoring group, Cord blood DNA methylation will be assessed using the Methylation EPIC BeadArray (850,000 CpG sites). We will identify DMCpGs and DMRs, together with the networks and transcriptional hubs associated with GDM and the potential mediators and pathways., 12 months
Secondary Outcome Measures: Comparison of Maternal HbA1c in first and third trimesters, Data from clinical records will be used to compare between the two groups (i) HbA1c in first and third trimesters, 12 months|Comparison of type of labour between both study groups, We will compared between both groups the rate of spontaneous labour, induced labours or caesarean section, 12 months|Comparison of requirement for drug treatment with metformin or insulin between both groups, Clinical data on treatment with insulin and/or metformin will be recorded for both cohorts and compared, 12 months|Comparison of rates of postpartum haemorrhage (>500mls blood) and third degree tears among both groups, Complications such as haemorrhage, and perineal trauma will be compared between groups, 12 months|Comparison of the composite neonatal outcome between both groups, Data from clinical records will be used to record and compare the composite neonatal outcome (stillbirth, hypoglycaemia, jaundice, admission to neonatal unit), 12 months|Comparison of rates of shoulder dystocia between both study cohorts, Data on the number of cases of shoulder dystocia will be compared between the both study groups, 12 months