Actively Recruiting
Preconception to Post-partum Study of Cardiometabolic Health in First Pregnancy
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2024-04-09
3500
Participants Needed
7
Research Sites
1304 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
U
University of Cambridge
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the link between placental complications during pregnancy and later risks of heart disease and diabetes in women. This study focuses on women who have never been pregnant before and aims to understand how conditions like pre-eclampsia, gestational hypertension, and fetal growth restriction may affect heart and metabolic health before, during, and after pregnancy. A control group of women not planning pregnancy will also be included to compare differences. Participants will be grouped based on their pregnancy plans: one group actively trying to conceive within about 12 months, and another group not planning to conceive for at least 18 months. The study does not involve treatment but will observe these women over time, with visits before pregnancy, during pregnancy, and 9 to 12 months after delivery for those who become pregnant. The study duration varies from 12 to 33 months depending on pregnancy timing and outcomes. Throughout the study, women will undergo various assessments including blood pressure, body measurements, blood tests for cholesterol, glucose and other markers, urine tests, and heart function scans. Researchers will measure risk differences for heart disease and diabetes using tools like QRISK3 and oral glucose tolerance tests. Safety and health will be monitored throughout, with the goal of understanding how placental syndromes affect maternal cardiometabolic health independently of pre-pregnancy condition.
CONDITIONS
Brief Title
Cardiometabolic Health in First Time Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 45 years
- Nulliparous (no previous pregnancy beyond 20 weeks' gestation)
- Ability to consent and willing to participate
- For Pregnancy Arm: actively planning to conceive within approximately 12 months
- For Non-Pregnancy Arm: not planning to conceive during the next 18 months
You will not qualify if you...
- Currently pregnant
- Assigned male sex at birth
- Established infertility
- Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
- Autoimmune diseases such as rheumatoid arthritis or lupus
- Thrombophilia
- Type 1 diabetes
- Known advanced chronic kidney disease (stages 4-5)
- Malignant hypertension
- Clinically manifest cardiovascular disease (e.g. previous heart attack or stroke)
- Active cancer or currently being treated for cancer (except skin cancer)
- Any other condition preventing full participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 33 months
Participants are observed over time to assess cardiometabolic health before, during, and after pregnancy, depending on their study arm.
Multiple visits over the study duration depending on pregnancy occurrence and study arm
Duration - Up to 18 months postpartum or after enrollment
Participants are followed up to assess cardiometabolic health outcomes up to 18 months postpartum or after enrollment for non-pregnant participants.
1 to 2 follow-up visits depending on pregnancy outcome
Trial Site Locations
Total: 7 locations
1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
2
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Actively Recruiting
3
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Not Yet Recruiting
4
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Not Yet Recruiting
5
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Not Yet Recruiting
6
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Actively Recruiting
7
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
Research Team
H
Heike Templin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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