Azithromycin-Prophylactic Labour Use Study ( A-PLUS)

Phase 4

Recruiting

• Conditions: maternal and newborn infections; maternal and newborn health; Paediatrics

• Registration Number: PACTR202004580322097
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 4250

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

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified