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

NCT06545227 | Recruiting DMC

• 1 other identifier: 304605
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.Women who are being managed in the pregnancy with early blood glucose monitoring (early monitoring group)
2. 2.Women who are being managed with an oral glucose tolerance test at 28-32 weeks (late monitoring group)
3. 3.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
4. 4.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.
5. 5.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.
6. 6.the microbiome differs between both groups
7. 7.the pathways that regulate insulin in the placenta
8. 8.the ability of the cells in the umbilical cord differentiate into the different fat cells.

Conditions

Pregnancy Complications; Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Comparison of Maternal HbA1c in first and third trimesters

  12 months

• Comparison of type of labour between both study groups

  12 months

• Comparison of requirement for drug treatment with metformin or insulin between both groups

  12 months

• Comparison of rates of postpartum haemorrhage (>500mls blood) and third degree tears among both groups

  12 months

• Comparison of the composite neonatal outcome between both groups

  12 months

Study Arms (2)

Early monitoring group

Women who are testing blood glucose four times a day from 28 weeks.

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

Late monitoring group

Women who have an oral glucose tolerance test at 28-32 weeks.

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

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)

Late monitoring group

Collection of urine, maternal blood at baseline and 28 weeks in a subset of women (n=25) OTHER

To study maternal metabolome

Early monitoring group; Late monitoring group

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.

Early monitoring group; Late monitoring group

Maternal and neonatal outcome data collection for all women in the study OTHER

Data for maternal and neonatal outcomes will be collected

Early monitoring group; Late monitoring group

Eligibility Criteria

• Age: 17 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women with a history of gestational diabetes in a previous pregnancy diagnosed by an oral glucose tolerance test.

You may qualify if:

• Age \>16
• Pregnant
• Previous pregnancy with gestational diabetes diagnosed by an Oral Glucose Tolerance Test
• Singleton pregnancy

You may not qualify if:

• Women with the following risk factors will be excluded:
• Multiple pregnancy
• History of bariatric surgery
• Taking metformin or other oral hypoglycaemic agents
• HbA1c more than or equal to 48

Sponsors & Collaborators

• Imperial College London: lead
• Bold insight: collaborator
• DexCom, Inc.: collaborator

Study Sites (1)

Chelsea and Westminster Trust

London, SW10 9NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

• Natasha Singh, MBBS FRCOG

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Natasha Singh, MBBS FRCOG

CONTACT

02033159892; n.mohammed@imperial.ac.uk

Mark Pandrich, MBBS

CONTACT

02033159892; mark.pandrich@nhs.net

Study Design

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

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: August 9, 2024
• Study Start: November 20, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months after study completed and will remain available for 12 months after
• Access Criteria: Researchers undertaking similar research will be able to have access to the data and study documents. The data will be shared via email and will by anonymised The Chief investigator will review the request

Locations

GB (1)