Cardiometabolic Health in First Time Pregnancy

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · May 3, 2023

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: Cardiometabolic Health in First Time Pregnancy**

This clinical trial is studying how certain pregnancy complications, like high blood pressure and small baby size, can affect a woman's risk of developing heart disease and diabetes later in life. Researchers want to learn more about these risks in women who are planning to get pregnant and those who are not planning pregnancy, to see if these complications make a difference in heart health. By understanding this better, the goal is to find ways to reduce these risks and potentially prevent these pregnancy complications in the future.

To participate in the trial, women aged 18 to 45 who have never been pregnant before (beyond 20 weeks) can join if they are either planning to conceive within the next year or not planning to conceive at all in the next 18 months. Participants will undergo assessments before and during their pregnancy, as well as 9-12 months after giving birth, to monitor their heart health and related factors. It's important to know that women with certain health conditions, like autoimmune diseases or advanced kidney problems, or those currently pregnant, cannot take part in this study.

Gender

FEMALE

Eligibility criteria

• 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 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