RecruitingNCT05856318

Cardiometabolic Health in First Time Pregnancy

Preconception to pOst-partum Study of Cardiometabolic Health in Primigravid PregnancY


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

3,500 participants

Start Date

May 24, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria33

  • To be included in the trial the participant must:
  • 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
  • Currently pregnant
  • Established infertility
  • Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
  • Assigned male sex at birth
  • Autoimmune disease (e.g. rheumatoid arthritis, lupus)
  • Thrombophilia
  • Type 1 diabetes
  • Known advanced chronic kidney disease (stages 4-5)
  • Malignant hypertension
  • Clinically manifest CVD (e.g. previous myocardial infarction, stroke)
  • Active cancer/being treated for cancer currently (other than skin cancer)
  • Any other condition preventing full participation in the study
  • To be included in the trial the participant must:
  • Nulliparous (no previous pregnancy beyond 20 weeks' gestation)
  • Not planning to conceive during next 18 months
  • Aged between 18 and 45 years
  • Ability to consent and willing to participate
  • Currently pregnant
  • Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
  • Assigned male sex at birth
  • Autoimmune disease (e.g. rheumatoid arthritis, lupus)
  • Thrombophilia
  • Type 1 diabetes
  • Known advanced chronic kidney disease (stages 4-5)
  • Malignant hypertension
  • Clinically manifest CVD (e.g. previous myocardial infarction, stroke)
  • Active cancer/being treated for cancer currently (other than skin cancer)
  • Any other condition preventing full participation in the study

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Locations(7)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

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NCT05856318


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