Does maternal body fat amount and location impact pregnancy health?

Not Applicable

• Conditions: Adiposity in pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN82185177
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37699635/ (added 14/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-07
• Last Update Posted: 18 March 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1400

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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