Maternal sepsis Pregnancy and Childbirth
Conditions
Interventions
Day 0: We will obtain consent from individuals who meet the inclusion criteria to participate. After which we will collect the participants' medical and obstetric history
details about the current or most recent pregnancy
Vital signs such as blood pressure, pulse, temperature, oxygen levels, urine output. We will collect one extra blood sample (ideally at the same time as routine samples) approximately 2.5ml to test fo
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Be pregnant or within 6 weeks of the end of the pregnancy. 2. Women with a suspected or confirmed infection requiring in-patient care: 2.1. Any suspected or confirmed infection with or without organ-dysfunction. 2.2. Any clinical signs suggestive of infection (e.g., fever). 2.3. Request for any bodily fluid culture (blood, urine, cerebrospinal fluid, etc.) or swab specimens (nasopharyngeal, oropharyngeal, vaginal, endocervical) for the diagnosis of suspected infection (not routine sampling e.g., routine COVID-19 screening). 2.4. Non-prophylactic use of antibiotics or other antimicrobial drugs at admission or during hospital stay. 2.5. Any procedure for treatment of a suspected infection (e.g., wound exploration, evacuation of the uterus, laparotomy, etc.) 2.6. Any unexplained organ-dysfunction (i.e., organ dysfunction not attributable to an underlying cause). 3. Estimated age =16 years. 4. Willing to provide a signed (and witnessed, if applicable) informed consent form. 5. Willing to be contacted, if necessary. 6. Willing to have additional blood samples taken.
Exclusion criteria
Exclusion criteria: 1. Women in active labour or within 2 hours of delivery are excluded as lactate is expected to be elevated by labour and childbirth. 2. Women with any non-severe, localised, or chronic infection (TB, HIV) or colonization (GBS) 3. Women undergoing only treatment with prophylactic antibiotics (for procedures, GBS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal sepsis will be assessed using venous lactate measurement in addition to maternal vital sign thresholds at two time points following inclusion: Day 0 (blood sample 1) and Day 1 (blood sample 2) taken 22 -36 hours after sample 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard. Maternal venous blood lactate will be measured at baseline using the blood sample collected (day 0) at the same timepoint that maternal sepsis will be assessed. 2. Short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline. Maternal venous blood lactate will be measured at baseline (day 0 blood sample ), and in those without sepsis at baseline the index test will be assessed against the reference standard at day 1. 3. Severe morbidity and mortality from infection. This will be assessed daily until day 14 or discharge or death if sooner: Day 0-14. 4. Pregnancy status (pregnant or post-delivery/post miscarriage/post-abortion) and country of recruitment | — |
Countries
Malawi, Pakistan, Uganda
Contacts
Public ContactSonia Whyte
Outcome results
None listed