Prevention of maternal and neonatal death/infections with a single oral dose of azithromycin in women in labor (in low- and middle-income countries): a randomized controlled trial - A-PLUS Trial

Eunice Kennedy Shriver National Institute of Child Health and Human Development0 sites9,586 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Health Condition 1: O85- Puerperal sepsis
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development
Enrollment: 9586
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development

•The A\-PLUS main trial:
•1\.Pregnant women in labor more than or equal to 28 weeks GA (by best estimate) with a pregnancy with one or more live fetuses who plan to deliver vaginally in a facility.
•2\.Admitted to health facility with clear plan for spontaneous or induced delivery.
•3\.Live fetus must be confirmed via a fetal heart rate by Doptone prior to randomization.
•4\. More than or equal to 18 years of age.
•5\. Have provided written informed consent \[Note: written informed consent may be obtained during antenatal care, but verbal re\-confirmation may be needed (per local regulations) at the time of randomization]
•Antimicrobial Resistance (AMR) Monitoring Sub\-study:
•1\. Randomized and treated mothers or their babies diagnosed with infections up to 6 weeks after delivery
•The A\-PLUS Pilot Study on Infection:
•same as for main study

•The A\-PLUS main trial:
•1\. Non\-emancipated minors (as per local regulations)
•2\. 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).
•3\. Arrhythmia or known history of cardiomyopathy.
•4\. Allergy to azithromycin or other macrolides that is self\-reported or documented in the medical record.
•5\. Any use of azithromycin, erythromycin, or other macrolide in the 3 days or less prior to randomization. Plan for cesarean delivery prior to randomization.
•6\. Preterm labor undergoing management with no immediate plan to proceed to delivery.
•7\. Advanced stage of labor ( \>6 cm or 10 cm cervical dilation per local standards) and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation.
•8\. Are not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum haemorrhage) or mental disorder.
•9\. Any other medical conditions that may be considered a contraindication per the judgment of the site investigator.