Cardiometabolic Health in First Time Pregnancy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorCambridge University Hospitals NHS Foundation Trust

About this trial

Women who experience placental complications (syndromes) during pregnancy, such as pre-eclampsia (high blood pressure and kidney problems), gestational hypertension (high blood pressure during pregnancy) and fetal growth restriction (baby being small) have twice the risk of developing heart disease and diabetes later in life, compared to women who have a healthy pregnancy.

This study aims to assess risk factors for heart disease and diabetes in women who are actively trying to conceive, before and during their pregnancy, and 9-12 months after delivery of their baby, to see whether placental syndromes make a difference to their heart health. This will allow us to understand, if, and how, placental syndromes increase the risk of heart disease and diabetes, and, therefore, how best to reduce this risk and potentially prevent placental syndromes in the future. The investigators will also recruit women who are NOT planning pregnancy, as a control group.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Nulliparous (no previous pregnancy beyond 20 weeks' gestation)

Actively considering pregnancy within approximately 12 months

Aged between 18 and 45 years

Ability to consent and willing to participate

Disqualifiers

Currently pregnant

Established infertility

Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)

Assigned male sex at birth

Trial population

Nulliparous women to maximise the occurrence of placental syndrome.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,500 Participants
are grouped into 2 trial groups
Group A: Pregnancy ~3000 participants
Group B: Non-Pregnancy ~500 participants

Trial outcomes

Primary outcomes

1

QRISK3

Predicted lifetime CVD risk

Time frame
Risk difference between women who experienced a healthy pregnancy and those who experienced a pregnancy complication at 9-12 months postpartum

Secondary outcomes

1

Blood Pressure Systolic, Blood Pressure Diastolic Pulse Wave Analysis: Supine Systolic BP, Supine diastolic BP, Central Systolic BP, Central diastolic BP, Supine MAP

BP (mmHg)

Time frame
Assessed at 9-12 months postpartum
2

Height

m

Time frame
Assessed at 9-12 months postpartum
3

BMI

kg/m2

Time frame
Assessed at 9-12 months postpartum
4

BMR

KJ

Time frame
Assessed at 9-12 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cambridge University Hospitals NHS Foundation Trust

Lead sponsor

University of Cambridge

Collaborator

University of Bristol

Collaborator

University College, London

Collaborator

King's College London

Collaborator

Imperial College London

Collaborator

St George's, University of London

Collaborator

University of Glasgow

Collaborator

Wellcome Trust

Collaborator