Gestational Diabetes Monitoring and Management

NCT06963528 | Active Not Recruiting

• 2 other identifiers: 301255_Minor Amendment 5IRAS 301255
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal is to predict the clinical outcomes of mother and baby using blood glucose and other routinely collected clinical data in pregnancy to predict adverse outcomes at birth in women with GDM. The secondary goal is to develop models to predict optimal blood glucose testing schedules for pregnant women. Exploratory Objectives are (1) to understand patterns of dosage and / or medication choice and (2) to describe different phenotypes of gestational diabetes based on multiple data input.

Conditions

Gestational Diabetes; Pregnancy Complications; Pregnancy in Diabetic; Pregnancy, High Risk; Diabetes Complications; Pregnancy Induced Hypertension; Pregnancy Weight Gain; Gestational Hypertension; Gestational Weight Gain; Gestational Diabetes Mellitus in Pregnancy; Gestational Complication; Gestational Mother; Pregnancy Preterm; Pregnancy Bleeding; Pregnancy Loss; Birth Weight; Birth Outcome, Adverse; Birth, Preterm; Birth Hypoxia

Keywords

gestational diabetes; machine learning; predictive monitoring; clustering; patient subtype; deep learning; transfomer model; foundation model; diabetes; blood glucose; c section; high risk pregnancy; diabetes complications

Outcome Measures

Primary Outcomes (4)

• Clinical outcome of mothers at birth

  Gestational age at delivery in years, Mode of delivery (vaginal, caesarean, assisted) as categocial measurements, Maternal weight gain in kg, Maternal pregnancy-induced hypertension in binary Yes or No, Maternal pregnancy-induced pre-eclampsia in binary Yes or No.

  From enrollment to the delivery date, assesed upto 52 weeks.

• Clinical outcome of mothers after birth

  Perineal trauma (3rd- or 4th-degree perineal tear or tear requiring suturing in the operating room) in text notes, Admission to higher level of care for mother in ICD codes, Length of hospital stay for mother in days, Method of feeding at discharge from hospital in texts.

  From the delivery date to the date that mother was discharged from the hospital, assessed up to 52 weeks, whichever come first.

• Clinical outcome of neonates at birth

  Newborn status at birth in categocial (alive, stillbirth), Birth weight in kg, Gender of neonate in categocial of male or female, APGAR score at 5 mins in numerical numbers from 0 to 10.

  From enrollment to the delivery date to the date to giving birth, assesed upto 52 weeks.

• Clinical outcome of neonates after birth

  Incidence of shoulder dystocia/birth injury in ICD codes to indicate yes or no, Incidence of neonatal hypoglycaemia in ICD codes to indicate Yes or No, Incidence of neonatal significant hyperbilirubinemia in ICD codes to indicate Yes or No, Length of hospital stay for neonate in days.

  From the delivery date to the date that neonate was discharged from the hospital, assessed up to 52 weeks, whichever come first.

Study Arms (1)

Mothers with diabetes in pregnancy

Mothers with first appearance of diabetes in pregnancy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Routinely collected from the NHS and submerged into four groups, including Caucasian, Asian, Black, and other

You may qualify if:

• Pregnant women with GDM during pregnancy
• Record of blood glucose monitoring registered on the GDm-Health system

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Women who have not consented for their data to be shared through GDm-Health
• Women who opted out of the use of their data in health research

Sponsors & Collaborators

• University of Oxford: lead
• Royal Academy of Engineering: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

University of Oxford

Oxford, OX1 3PJ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Pregnancy in Diabetics; Diabetes Complications; Hypertension, Pregnancy-Induced; Gestational Weight Gain; Birth Weight; Premature Birth; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Huiiq Yvonne Lu

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 9, 2025
• Study Start: December 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: August 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)