Preeclampsia Clinical Trial
Official title:
Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia - Prevalence and Association Between Pulmonary Interstitial Syndrome and Cardiac Dysfunction, Brain Natriuretic Peptide, and Serum Albumin
The study is planned to describe the prevalence and severity of cardiac, lung and optic-nerve sheath diameter (ONSD) ultrasound abnormalities in women with early onset preeclampsia with severe features. These findings will be compared with point-of-care ultrasound (POCUS) abnormalities demonstrated in our recent study on late onset preeclampsia. The primary aim of the current study will be to examine the association between pulmonary interstitial edema (PIS), as identified by lung ultrasound, and cardiac dysfunction on echocardiography, and brain natriuretic peptide (BNP), in early onset preeclampsia, after comprehensive echocardiographic assessment. The secondary aims are to assess ONSD, and to explore the association between PIS or ONSD and serum albumin. A further secondary aim will be to explore the association between POCUS abnormalities and cardiotocography abnormalities and early delivery.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Patients diagnosed and admitted with early onset preeclampsia with severe features Exclusion Criteria: 1. Body mass index (BMI) > 50 kg/m2 2. Clinical evidence of pulmonary oedema 3. The presence of a non-reassuring fetal heart trace 4. Active labour 5. Chronic pulmonary disease, or acute asthma 6. Collagen disorders 7. Chronic renal or hepatic disease 8. Urinary tract infection 9. Chorioamnionitis 10. Intrauterine fetal death 11. Patients unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
South Africa | Groote Schuur Hospital | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Stanford University |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The association between pulmonary interstitial syndrome and cardiac dysfunction on echocardiography | More than 3 B-lines in 2 lung windows bilaterally defines the presence of pulmonary interstitial syndrome.
Cardiac dysfunction on echocardiography is defined as raised left ventricular end-diastolic pressure as demonstrated on echocardiography. |
35-40 minutes | |
Secondary | The association between pulmonary interstitial syndrome or optic nerve sheath diameter, and serum albumin | Please see description for outcome 1 for pulmonary interstitial syndrome. Abnormal optic nerve sheath diameter is defined as greater than 5.8 mm. Brain natriuretic peptide and serum albumin are continuous variables. | 35-40 minutes. | |
Secondary | The prevalence and severity of cardiac, lung and optic nerve sheath diameter abnormalities in women with early onset PE | Please see definitions as described under Outcome 1 and Outcome 2. | 35-40 minutes |
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