CTRI/2019/04/018406已完成3 期
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 个研究点目标入组 9,586 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9,586
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
- •10. Previous randomization in the trial.
- •The A-PLUS Pilot Study on Infection:
- •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. Preterm labor undergoing management with no immediate plan to proceed to delivery.
- •4. 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.
- •5. Are not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum haemorrhage) or mental disorder.
研究者
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