1. SHAPES cohort study
The SHAPES cohort study has been used as a risk prediction model development dataset. The study aimed to measure alternative measurements of obesity/adiposity (to BMI) in early pregnancy to explore the ability of these measures to predict adverse pregnancy outcomes. This risk prediction study has been used to explore how well individual measures of adiposity (e.g. waist circumference) predict risk compared with BMI, and will also explore whether there is added benefit of creating a risk prediction model, including adiposity measures as well as socio-demographic and clinical factors.
The SHAPES cohort study began recruitment in April 2022 and it continued until April 2024, with 1450 participants taking part during their first trimester scan at the Royal Victoria Infirmary, Newcastle upon Tyne NHS Trust. A summary of the recruitment process can be found here.
Early pregnancy adiposity measures were collected at the 12-week scan appointment, including weight, height, waist circumference, hip circumference, neck circumference, visceral fat and subcutaneous fat (measured by ultrasound), skinfolds, and other potential predictor variables of interest for a multi-variable model (including clinical and socio-demographic data). Data on pregnancy outcomes was collected from routine hospital records after delivery and all babies of the participants were born by November 2024. The outcomes of interest are:
|
Outcomes |
Definition |
|
Maternal outcomes |
|
|
Gestational diabetes |
Fasting plasma glucose level of ≥ 5.6 mmol/litre or 2-hour plasma glucose level of ≥7.8 mmol/litre
|
|
Gestational hypertension |
Blood pressure ≥140/90 mmHg on two occasions at least 4 hours apart after 20 weeks’ gestation |
|
Preeclampsia |
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. |
|
Induction of labour |
Non-surgical treatment to induce the labour |
|
Caesarean section |
Surgical delivery of baby (emergency or elective) |
|
Instrumental delivery |
Assisted birth when forceps or a ventouse suction cup is applied |
|
Retained placenta |
As reported in medical records. |
|
Maternal infection |
As reported in medical records. |
|
Blood loss during delivery |
3rd stage of labour and immediate postpartum period, measured in ml blood loss |
|
Maternal length of stay in hospital |
From admission date for any stay resulting in delivery to date of discharge |
|
Infant outcomes |
|
|
Fetal growth |
Measured at 2nd and 3rd trimester scans, including: 2nd trimester scan: Fetal head circumference; Fetal abdominal circumference; Fetal Femur Length; Estimated fetal weight Hadlock 3rd trimester scan: abdominal circumference; Femur Length; Estimated fetal weight Hadlock; Umbilical artery PI; End Diastolic flow; Amniotic Fluid Index |
|
Pre-term birth |
Birth before 37 weeks gestation |
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Late-term birth |
Pregnancy that extends over 41 weeks gestation |
|
Large for gestational age |
birth weight above the 90th centile for gestational age and sex on INTERGROWTH chart |
|
Small for gestational age |
Birth weight below the 10th centile for gestational age and sex on INTERGROWTH chart [32] |
|
Apgar score |
1 and 5 minutes |
|
Neonatal respiratory distress (requiring resuscitation) |
Any of the following: Cords visualised meconium seen; Cord visualised no meconium; Facial air; Facial oxygen; Mucus extraction or suction; Positive pressure by bag or mask; Positive pressure by endotracheal tube |
|
Feeding method |
First feed: Artificial; Breast mother; Breast donor; Breast and artificial; No feed given Feed method at discharge: breastfeeding or artificial feed or both breast and artificial |
|
Infant admission to specialist care |
admission to neonatal special care baby unit (SCBU) or intensive care unit (NICU), high-dependency care, transitional care; length of stay if admitted |
Data collected from this phase has been analysed to explore if any single adiposity measure taken in this study performs better than BMI in terms of predicting women at high risk of an adverse pregnancy outcome. Each adiposity measure is being assessed individually. If no one measure performs better than BMI then multi-variable models will be developed and tested to identify the most parsimonious (and therefore most preferable from implementation into routine practice perspective) model. The apparent performance of the developed model will be summarised in the development dataset using calibration, discrimination, and internal validation analyses.
- The analysis plan for SHAPES cohort study can be found here: SHAPES Cohort SAP
- Here is a copy of the study protocol. If you require further information about the research please contact Professor Nicola Heslehurst or the Research Teams.
Ethical approval for this cohort study
The SHAPES cohort study was approved by the North East - Newcastle & North Tyneside 1 NHS Research Ethics Sub-Committee (REC reference: 22/NE/0035). It is an NIHR Portfolio adopted study.
