Using a blood test alongside body fat measurements for obesity risk prediction to improve pregnancy outcomes

ISRCTN	ISRCTN13935752
DOI	https://doi.org/10.1186/ISRCTN13935752
National Institute for Health and Care Research (NIHR)	208188
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder	Research for Patient Benefit Programme

Submission date: 22/01/2026
Registration date: 06/03/2026
Last edited: 06/03/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Increasing numbers of people experience pregnancy complications linked to the amount of body fat people have, and where abouts on their body fat is stored (known as adiposity). Risk prediction research helps to identify who is most likely to develop complications to help plan care. Current guidelines use body mass index (BMI), a measure of a person’s height and weight, to assess risk and plan care. Our current research, called SHAPES, shows that using BMI misses half of the pregnant people who develop diabetes, and we need to find a better measure. We found that waist size and ultrasound scans of stomach fat worked better than BMI. Other studies show that using biomarkers (chemicals in the blood, like hormones) can improve risk prediction. This study aims to explore whether combining adiposity measures and biomarkers can help identify who will develop pregnancy complications.

Who can participate?
No new participants required. We use data and samples from the SHAPES study, which completed its recruitment in April 2024.

What does the study involve?
We will use SHAPES data on adiposity and pregnancy outcomes for SHAPES-Bio. We have permission from SHAPES research participants to use their existing blood samples to test for biomarkers. We will compare different combinations of biomarkers and adiposity measures (such as waist size or ultrasound scans of stomach fat) to see which combinations work best to predict pregnancy complications.

What are the possible benefits and risks of participating?
Not applicable as no participants were recruited for this study.

Where is the study run from?
Newcastle upon Tyne NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2022 to October 2026

Who is funding the study?
NIHR Research for Patient Benefit (RfPB) (UK)

Who is the main contact?
Raya Vinogradov, raya.vinogradov@ncl.ac.uk

Contact information

Mrs Janine Smith
Public

Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom

Phone	+44 (0)191 282 0540
Email	hello@janine-smith.com

Mrs Raya Vinogradov
Principal investigator

Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom

ORCID ID	0000-0001-9375-7915
Phone	+44 (0)1912820540
Email	raya.vinogradov@newcastle.ac.uk

Prof Nicola Heslehurst
Scientific

Population Health Sciences Institute
Baddeley-Clark building
Faculty of Medical Sciences
Newcastle University
Newcastle upon Tyne
NE2 4BN
United Kingdom

Phone	+44 (0)1912820540
Email	nicola.heslehurst@ncl.ac.uk

Study information

Primary study design	Observational
Observational study design	Retrospective cohort study
Scientific title	Using a blood test alongside body fat measurements for obesity risk prediction to improve pregnancy outcomes
Study acronym	SHAPES-Bio
Study objectives	Determining whether adding biomarkers to adiposity risk prediction model(s) for pregnancy complications can improve accuracy compared to current practice
Ethics approval(s)	Approved 18/06/2025, North East - Newcastle & North Tyneside 1 Research Ethics Committee (2nd Floor, 2 Redman Place, Stratford, E20 1JQ, United Kingdom; Not available; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 22/NE/0035
Health condition(s) or problem(s) studied	Pregnancy outcomes
Intervention	Data from the SHAPES study will be used, with serum samples from 885 participants. Biochemical measures will include a traditional lipid panel, adiponectin, gamma-glutamyl transferase, sex-hormone binding globulin, and ferritin. Robust predictive models will be built allowing for missing data and using resampling methods to calculate optimism-corrected performance. Decision curve analysis will compare the clinical net benefit of each model with current practice.
Intervention type	Other
Primary outcome measure(s)	Gestational diabetes measured using fasting plasma glucose level of ≥5.6 mmol/litre or 2-hour plasma glucose level of ≥7.8 mmol/litre at gestation at diagnosis
Key secondary outcome measure(s)	Pre-term birth measured using birth before 37 weeks gestation at gestation at delivery Late-term birth measured using pregnancy that extends over 41 weeks gestation at gestation at delivery Induction of labour measured using non-surgical treatment to induce the labour at intrapartum Caesarean section measured using surgical delivery of baby (emergency or elective) at intrapartum Retained placenta measured using medical records at postnatal period Haemorrhage measured using milliliters of blood loss at third stage of labour and immediate postpartum period Maternal infection measured using medical records at antenatal, intrapartum and postnatal Large for gestational age measured using birth weight above the 90th centile for gestational age and sex on INTERGROWTH chart at birth Small for gestational age measured using birth weight below the 10th centile for gestational age and sex on INTERGROWTH chart at birth Apgar scores at 1 and 5 minutes (score 1-10) measured using medical records at birth Jaundice measured using medical records at birth Feeding method measured using medical records at first feed and feed method at discharge Admission to neonatal special care baby unit (SCBU) or intensive care unit (NICU), high-dependency care, transitional care measured using medical records at postnatal Preeclampsia measured using a new onset of hypertension (>140 mmHg systolic or >90 mmHg diastolic) after 20 weeks of pregnancy with a new onset of proteinuria or/and maternal organ dysfunction or/and uteroplacental dysfunction. Early onset defined as onset of PE before 34 weeks gestation. at gestation of onset
Completion date	31/10/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	900
Total final enrolment	885
Key inclusion criteria	1. Pregnant with a singleton pregnancy 2. Presenting to a scan at 11+2 to 14+1 weeks gestation 3. ≥18 years of age 4. Planned to deliver locally
Key exclusion criteria	1. Unable/unwilling to give informed consent to participate 2. Women with a miscarriage prior to the 12-week scan, or threatened miscarriage identified on the patient's records as a visit to the Early Pregnancy Assessment Clinic (EPAC) or A&E relating to their pregnancy with an adverse outcome, will be excluded. 3. Women having twins (or higher order pregnancy) - we will not know whether women have a multiple pregnancy until their 12-week scan appointment (after consent). Any women identified as having a multiple pregnancy at the 12-week scan will be excluded. They will still receive the thank-you gift of pregnancy photographs.
Date of first enrolment	28/04/2022
Date of final enrolment	04/04/2024

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Newcastle upon Tyne NHS Foundation Trust

The Reproductive Health & Neonates Research Team, Level 6, Leazes Wing, Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

26/01/2026: Study's existence confirmed by the collaborators' agreement.