Sepsis Pregnancy and Childbirth Sepsis
Conditions
Interventions
Participants are randomly allocated to one of two groups. Randomisation is done using a random generator by a statistical software. Randomisation is performed centrally and is stratified for each of t
Sponsors
Centro Rosarino de Estudios Perinatales
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Singleton pregnant women 2. Aged 14 years and older 3. Vaginal or cesarean section delivery 4. Informed consent granted 5. Gestation period between 24 and 30 weeks and six days
Exclusion criteria
Exclusion criteria: 1. Congenital malformations or genetic syndrome (antenatal diagnosis or in the delivery room) 2. Rh-sensitized pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proven sepsis rates in new born infants is measured on the basis of clinical condition compatible with positive blood and/or cerebrospinal fluid and/or urine cultures (urine must be obtained by urethral catheterization or bladder puncture) at three days after birth and up until discharge from the hospital 2. Very probable sepsis rates in new born infants is measured on the basis of clinical signs of sepsis, negative cultures, antibiotic treatment equal or greater than seven days and two or more of the following diagnostic test results: 10mg/L, <100,000 platelets/mm3, at three days after birth and up until discharge from the hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant outcomes: 1. Health at birth is measured using the Apgar scale at one and five minutes after birth 2. Assistance at birth is measured using time of first breath and need for bag mask-ventilation at hospital discharge 3. Intracranial hemorrhage is measured using brain ultrasonography following Papille´s classification (grades 1-4) at 24-48 hours after birth 4. Respiratory distress syndrome (RDS) using clinical indicators and chest x-rays at any time before discharge from the hospital 5.Symptomatic patent ductus arteriosus (PDA) is measured using echocardiography at any time before discharge form the hospital 6. Necrotizing enterocolitis (NEC) is measured using clinical and radiological findings according to Bell´s staging criteria at any time before discharge from the hospital 7. Bronchopulmonary dysplasia (BPD) is measured using clinical and radiological findings at any time before discharge from the hospital 8. Retinopathy of prematurity (ROP) is measured using alterations compatible with retinal grades at any time before discharge from the hospital 9. Death is measured through patient records at occurrence moment 10. Neurodevelopment is measured using Bayley scales at 18-24 months of age 11. Central packed cell volume are measured using blood samples at 6 and 24 hours after birth 12. Plasma bilirubin level are measured using blood samples at 24, 72 and 120 hours after birth 13. Plasma ferritin level are measured using blood samples at discharge from hospital 14. White blood cell count and C-reactive protein (CRP) in preterm infants with suspected sepsis are measured using blood samples at any time before discharge from the hospital 15. Blood pressure is measured using blood pressure cuffs at 2, 6,12 and 24 hours after birth Maternal outcomes: 1. The proportion of women with blood loss of 500 mL or more is measured by collecting blood loss at one hour postpartum (or two hours postpartum if the bleeding continues beyond one hour) 2. The proportion of women w | — |
Countries
Argentina
Outcome results
None listed