Skip to content

Does maternal body fat amount and location impact pregnancy health?

Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): a cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN82185177
Enrollment
1400
Registered
2023-03-07
Start date
2022-03-16
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity in pregnancy Pregnancy and Childbirth

Interventions

All pregnant women who book their antenatal care with the Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH) are sent a research information letter outlining that NUTH is a research active Trus

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy (women who consent to participate but who are subsequently found to have a multiple pregnancy will be excluded) 2. =18 years of age 3. Approximately 12 weeks’ gestation (11+2 to 14+1 weeks) 4. Planned delivery at NUTH

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
All outcomes are collected from routine maternity records following birth: 1. Gestational diabetes: fasting plasma glucose level of = 5.6 mmol/litre or 2-hour plasma glucose level of =7.8 mmol/litre 2. Preeclampsia (PE): 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. 3. Pre-term birth: birth before 37 weeks gestation 4. Small for gestational age: birth weight below the 10th centile for gestational age and sex on INTERGROWTH chart 5. Large for gestational age: birth weight above the 90th centile for gestational age and sex on INTERGROWTH chart 6. Caesarean section: surgical delivery of baby (emergency or elective)

Secondary

MeasureTime frame
All outcomes collected from routine maternity records following birth: 1. Gestational hypertension: blood pressure =140/90 mmHg on two occasions at least 4 hours apart after 20 weeks gestation 2. Late-term birth: pregnancy that extends over 41 weeks gestation 3. Induction of labour: non-surgical treatment to induce the labour 4. Instrumental delivery: an assisted birth when forceps or a ventouse suction cup is applied 5. Retained placenta: as reported in medical records 6. Haemorrhage: 3rd stage of labour and immediate postpartum period, measured in ml blood loss; as reported in medical records 7. Maternal infection: as reported in medical records 8. Fetal growth: measured at 2nd and 3rd trimester scans, including: 8.1. 2nd trimester scan: fetal head circumference; fetal abdominal circumference; fetal femur length; estimated fetal weight Hadlock; as reported in medical records 8.2. 3rd trimester scan: abdominal circumference; femur length; estimated fetal weight Hadlock; umbilical artery PI; end diastolic flow; amniotic fluid index; as reported in medical records 9. Apgar scores at 1 and 5 minutes (score 1-10): as reported in medical records 10. Respiratory distress (including requiring resuscitation): as reported in medical records 11. Feeding method (first feed and feed method at discharge): breastfeeding or artificial feed; as reported in medical records 12. Admission to neonatal special care baby unit (SCBU) or intensive care unit (NICU), high-dependency care, transitional care: as reported in medical records

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026