Lactate Study

LACTATE: Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis

Aim: The purpose of the Lactate tests study is to determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low resource health facility settings in Malawi, Uganda, and Pakistan.

Secondary objective:

1. Immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard.

2. To assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline.

3. To explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection.

4. To explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the pre-specified subgroups of pregnancy status (pregnant or post-delivery/post miscarriage/post-abortion) and recruitment country.

5. Exploratory analysis will examine the effect of adjusting the threshold values for both vital sign and lactate assessment on sensitivity and specificity of the index tests.

6. Conduct a validation study to explore the use of an alternative reference standard in which the SOFA score is modified to use maternity specific ranges for creatinine and platelet concentration.

Study population

The study is recruiting women who are 16 years and above, suspected or confirmed to have maternal infection requiring inpatient care or currently hospital patients who are pregnant or within 6 weeks of end of pregnancy. The study duration will be 33 months with 1 year of active enrollment. Participants are recruited from the Queen Elizabeth Central Hospital.