maternal and newborn infections maternal and newborn health Paediatrics maternal and newborn infections
Conditions
Interventions
Azithromycin
Placebo
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Bill and Melinda Gates Foundation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Pregnant women in labor =28 weeks GA (by best estimate) with a pregnancy with one or more live fetuses who plan to deliver vaginally in a facility. • Admitted to health facility with clear plan for spontaneous or induced delivery. • Live fetus must be confirmed via a fetal heart rate by Doptone prior to randomization. • Have provided written informed consent at gestation 28 weeks or beyond during antenatal care or home visits by the study field staff. However, verbal re-confirmation will be done at the time of randomization].
Exclusion criteria
Exclusion criteria: • Non-emancipated minors. • Evidence of chorioamnionitis or other infection requiring antibiotic therapy at time of eligibility (however, women given single prophylactic antibiotics with no plans to continue after delivery should not be excluded). • Arrhythmia or known history of cardiomyopathy. • Allergy to azithromycin or other macrolides that is self-reported by the pregnant woman or documented in a recent or any medical record. • Any use of azithromycin, erythromycin, or other macrolide in the 3 days or less prior to randomization as established during the enrolment process through history taking. • Plan for cesarean delivery prior to randomization. • Preterm labor undergoing management with no immediate plan to proceed to delivery. • Advanced stage of labor of 10cm cervical dilatation and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation. • Any other medical conditions that may be considered a contraindication per the judgment of the site investigator • Previous randomization in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes are: •Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. •Neonatal: Incidence of intrapartum/neonatal death or sepsis within 7 days and 4 weeks (28 days) post-delivery in intervention vs. placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2.6 Other Maternal Outcomes a. Chorioamnionitis: Fever (>100.4°F/38°C on two occasions at least 30 minutes apart or =102°F/39°C on one occasion) in addition to one or more of the following: fetal tachycardia >160bpm, maternal tachycardia>100bpm, uterine tenderness, or purulent lochia prior to delivery. b. Endometritis: Fever (>100.4°F/38°C on two occasions at least 30 minutes apart or =102°F/39°C on one occasion) in addition to one or more of uterine tenderness or purulent lochia after delivery. c. Other infections:Wound infection refers to purulent infection (superficial or deep infection including necrotizing fasciitis) of a perineal wound or wound of a subsequent cesarean with or without fever and leading to prescription of antibiotics; abdominopelvic abscess is evidence of pus noted during open surgery, interventional aspiration or imaging; pneumonia refers to fever and clinical symptoms suggestive of lung infection including cough and tachypnea with or without radiological confirmation; pyelonephritis refers to fever, urinalysis/dip suggestive of infection and Costovertebral angle tenderness with or without confirmatory urine culture). d. Use of subsequent maternal antibiotic therapy after randomization to 6 weeks for any reason. e. Maternal initial hospital length of stay, defined as the time of admission until initial discharge (time may vary by site). f. Maternal readmissions within 6 weeks of delivery. g. Maternal admission to special care units. h. Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects. 2.7 Other Neonatal Outcomes a. Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site). b. Neonatal readmissions within 6 weeks of delivery. c. Neonatal admission to special care units. d. Neonatal death due to sepsis using the Global Network algorithm for causes of death. e. Pyloric stenosis within 6 weeks of delivery, defined as clinical s | — |
Countries
Kenya
Contacts
Public ContactAmos Sagwe
Moi University
Outcome results
None listed