Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID05856318

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

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

Loading map...

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

Similar Trials

A Cardiometabolic Health Program Linked With Clinical-Commun...

Hypertension

Actively Recruiting

3 locations

A Natural History Study of Metabolic Sizing in Health and Di...

Metabolic Disorders

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here