ENRICH ME STUDY- Examining the impact of an Early Intervention on incidence of poor cardiovascular health outcomes in women with pre-eclampsia and gestational hypertension.

Not Applicable

Recruiting

• Conditions: Heart disease; Pre-eclampsia; Gestational hypertension; Cardiovascular - Coronary heart disease; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12623001132639
• Lead Sponsor: Epworth medical foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-02
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Women over the age of 18 years with a recent pregnancy with a diagnosis of
• Gestational hypertension defined as new-onset hypertension in pregnancy (systolic blood pressure of 140mmHg or above and/or diastolic of 90mmHg or above
•Pre-eclampsia defined as new-onset hypertension in pregnancy (systolic blood pressure of 140mmHg or above and/or diastolic more than or equal to 90mmHg or with proteinuria, other specific end-organ dysfunction, or uteroplacental dysfunction, after 20 weeks of gestation.

Exclusion Criteria

•Pregnant women
•Women under the age of 18 years at delivery
•Women with any unstable medical conditions defined as any condition that changes frequently or rapidly or requires constant monitoring or frequent treatment regimens or conditions resulting in limited life expectancy. Or any medical condition that would preclude diet and exercise participation. Such as, any pre-existing cardiac disease with an abnormal cardiac function on Echocardiogram, Left ventricular failure (LVF) Congested cardiac failure (CCF).
•Insulin dependent diabetic (IDDM)with poor glycemic control, and recurrent episodes of hypoglycemia.
•Renal transplant patients, on multiple immunosuppressive medications.
•Chronic lung disease with impaired exercise tolerance.
•Women with cognitive impairment or who are unable to provide consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>The primary outcome will be a measured in the MEDAS questionnaire between the 3-month and 12-month assessments. The English version of the MEDAS (Mediterranean Diet Adherence Screener) <br>Change in dietary awareness of a heart healthy diet as determined by a dietary MEDAS assessment (as per Heart Foundation Heart Healthy Eating Recommendations)[ 3 months post the delivery of the baby at visit 1. <br>Visit 2 is 12 months post-delivery of baby.<br>Two separate time points]