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

Eunice Kennedy Shriver National Institute of Child Health and Human Development0 个研究点目标入组 4,250 人开始时间: 2020年3月13日最近更新: 2023年5月29日

试验速览

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•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].

•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.

发起方

Eunice Kennedy Shriver National Institute of Child Health and Human Development