Cardiometabolic Health in First Time Pregnancy (NCT05856318) | Clinical Trial Compass
RecruitingNot Applicable
Cardiometabolic Health in First Time Pregnancy
United Kingdom3,500 participantsStarted 2023-05-24
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pregnancy Arm Inclusion Criteria:
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
Pregnancy Arm Exclusion Criteria:
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)
* 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
Non-Pregnancy Arm Inclusion criteria
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
Non-Pregnancy Exclusion Criteria
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 art…
What they're measuring
1
QRISK3
Timeframe: Risk difference between women who experienced a healthy pregnancy and those who experienced a pregnancy complication at 9-12 months postpartum
Trial details
NCT IDNCT05856318
SponsorCambridge University Hospitals NHS Foundation Trust