- Cardiovascular
- Trials open to recruitment
POPPY
Research summary
The Preconception to pOst-partum study of cardiometabolic health in Primigravid PregnancY Study (POPPY) is an observational, prospective study, consisting of two arms: a Pregnancy arm (nulliparous women planning their first pregnancy; n~3000) and a Non-Pregnancy control arm (nulliparous women voluntarily planning not to conceive during their involvement in the study; n=500).
Rationale
The clinical manifestations of placental dysfunction include pre-eclampsia, gestational hypertension and fetal growth restriction. Women who experience placental dysfunction have a two-fold risk of cardiovascular disease (CVD) and diabetes in later life compared to women with uncomplicated pregnancies. However, it is unclear whether placental syndromes have a direct adverse effect on cardiometabolic health, whether a healthy pregnancy is protective, or whether women who experience a placental syndrome simply had poorer cardiometabolic health prior to pregnancy. If placental syndromes do lead to CVD and diabetes independently of established cardiometabolic risk factors (e.g. by causing end organ damage), a focus on CVD/diabetes prevention in this high risk group of women is likely to reduce the burden of these diseases. Conversely, if pre-pregnancy factors are more important, improving cardiometabolic health in young women prior to conception is key and could reduce the incidence of placental syndromes. We plan to assess cardiometabolic risk factors and validated intermediate phenotypes of CVD/diabetes before conception, during pregnancy, and post-partum to determine whether placental syndromes affect post-partum maternal cardiometabolic health independently of pre-conception cardiometabolic health. This will help to determine the optimal timing and nature of prevention strategies to reduce the burden of diabetes/CVD in women, in future trials.
Study Objectives
Primary objective
- To determine to what extent the association between placental syndromes and maternal cardio-metabolic health post-pregnancy is explained by pre-pregnancy subclinical cardiometabolic health.
Secondary objectives
- To determine whether pregnancy itself (i.e. a healthy pregnancy compared with no pregnancy) affects women’s cardiometabolic health post-pregnancy.
- To determine which pre-pregnancy cardiometabolic health measures affect the normal maternal haemodynamic adaptation to pregnancy and if early maladaptation is a biomarker for subsequent placental syndromes.
- To determine whether cardiometabolic health pre-pregnancy influences the risk of early fetal loss (<20 weeks of gestation).
Main inclusion criteria
Pregnancy study arm
To be included in the study the participant must be:
- Nulliparous (no previous pregnancy beyond 20 weeks’ gestation)
- Actively considering pregnancy within approximately 12 months
- Aged between 18 and 45 years
- Able to consent and willing to participate
Non-Pregnancy study arm – Inclusion criteria
To be included in the trial the participant must be:
- Nulliparous (no previous pregnancy beyond 20 weeks’ gestation)
- Not planning to conceive during their involvement in the study
- Aged between 18 and 45 years
Able to consent and willing to participate
Main exclusion criteria
Pregnancy study arm
The presence of any of the following will preclude participant inclusion:
- 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)
Non-Pregnancy study arm
The presence of any of the following will preclude participant inclusion:
- 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
Funders and sponsors
Funders: Wellcome
Sponsors: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Chief investigator
Chief investigator
Professor Ian Wilkinson
Contact details
Senior Clinical Trials Coordinator: Heike Templin
Telephone: 01223 250874 | Email: [email protected]