Azithromycin to Prevent Maternal and Neonatal deaths due to infection in Laboring Wome
- Conditions
- Health Condition 1: O85- Puerperal sepsis
- Registration Number
- CTRI/2019/04/018406
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9586
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The A-PLUS main trial <br/ ><br>•Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. <br/ ><br>•Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group. <br/ ><br>The A-PLUS Pilot study <br/ ><br>• Clinical sepsis diagnosed among pregnant/postpartum women and their infants <br/ ><br>•Other maternal infections <br/ ><br>•Frequency and types of pathogens identified by culture <br/ ><br>•Antibiotic useTimepoint: Up to 42 days postpartum
- Secondary Outcome Measures
Name Time Method