Gestational Diabetes Monitoring and Management

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 99 years
• Women only
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Predictive Monitoring and Management of Pregnant Women With Gestational Diabetes Mellitus

Conditions

Gestational Diabetes, Pregnancy Complications, Pregnancy in Diabetic, Pregnancy, High Risk, Diabetes Complications, Pregnancy Induced Hypertension

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

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 May 2025
2. Study start1 Dec 2021
3. Primary completion1 Sep 2023
4. Study completion31 Aug 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Gestational DiabetesStudies of the same condition, open and under way.
• More trials run by University of OxfordThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.