Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes

Sponsor
Imperial College London
Study ID
NCT06545227
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Pregnancy Complications

Eligibility Criteria

Sex
FEMALE
Age
17 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • continuous blood glucose monitoring in a subset of women (n=25) in the early monitoring group. — DEVICE
    To continuously monitor blood glucose from baseline to 28 weeks to determine if if there is hyperglycaemia in a subset of women (n=25)
  • Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25) — OTHER
    To study maternal metabolome
  • Collection of umbilical cord blood, placental samples and cord tissue in a subset of women (n=25) — OTHER
    To study mesenchymal stem cell differentiation, change in fetal epigenetic and placental signalling pathways.
  • Maternal and neonatal outcome data collection for all women in the study — OTHER
    Data for maternal and neonatal outcomes will be collected

Study Details

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.

Key Dates

First listed
Aug 9, 2024
Start date
Nov 20, 2023
Status verified
Aug 2024
Primary completion
May 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Early monitoring group
    Women who are testing blood glucose four times a day from 28 weeks.
  • Arm: Late monitoring group
    Women who have an oral glucose tolerance test at 28-32 weeks.

Primary Outcome Measure

Comparison of the maternal metabolome between the early monitoring group and the late monitoring group. [ Time Frame: 12 months ]

Central Contacts

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