umella test for detection of pre-eclampsia

Not Applicable

• Conditions: Pre-eclampsia; Pregnancy and Childbirth

• Registration Number: ISRCTN13430018
• Lead Sponsor: Advanced Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-10
• Last Update Posted: 12 December 2023
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Potential participants include cases with a risk of preeclampsia who meet the following criteria at the time of enrolment:
1. Age of 18 years or older
2. Singleton or twin pregnancy
3. Gestational age between 24+0 to 36+6 weeks
4. Able to provide informed written consent
5. Planned delivery at the study site or where maternal and newborn records will be available to the investigator for review

Cases with a risk of preeclampsia will be identified based on clinical and medical history criteria as follows:

Clinical risk factors:
1. Systolic blood pressure =130 mmHg on 1 or more occasion
2. Diastolic blood pressure =80 mmHg on 1 or more occasion
3. Elevated urinary protein:
3.1. Urine protein dipstick test 1+ or more
3.2. Urinary protein/creatinine ratio =0.30 mg/mg
3.3. Urinary protein =300 mg per day in timed collection
4. New onset low platelet count =100,000 x 109/L
5. New onset elevated serum creatinine =1.0 mg/dL
6. New onset transaminase elevation above limits of normal for local laboratory
7. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses
8. New onset visual symptoms
9. Fetal growth restriction with estimated fetal weight below 10th percentile

Historical/obstetrical risk factors:
1. History of preeclampsia
2. Multifetal pregnancy
3. Pre-existing hypertension
4. Pre-gestational diabetes mellitus
5. Pre-existing renal disease

Exclusion Criteria

1. Diagnostic criteria for preeclampsia already met at the time of enrolment
2. Delivery is planned prior to 37+0 weeks of gestation for reasons other than preeclampsia

Study & Design

• Study Type: Observational
• Study Design: Not specified