Status:
COMPLETED
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborating Sponsors:
University of Alabama at Birmingham
University Teaching Hospital, Lusaka, Zambia
Conditions:
Maternal Death
Maternal Infections Affecting Fetus or Newborn
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recen...
Detailed Description
The A-PLUS Trial is a randomized, placebo-controlled, parallel multicenter clinical trial. The study intervention is a single, prophylactic intrapartum oral dose of 2 g azithromycin, with a comparison...
Eligibility Criteria
Inclusion
- Pregnant women in labor ≥28 weeks Gestational Age (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.
- ≥18 years of age or minors 14-17 years of age in countries where married or pregnant minors (or their authorized representatives) are legally permitted to give consent.
- Have provided written informed consent.
- 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 presence of a fetal heart rate prior to randomization.
- ≥18 years of age or minors 14-17 years of age in countries where married or pregnant minors (or their authorized representatives) are legally permitted to give consent.
- Have provided written informed consent \[Note: written informed consent may be obtained during antenatal care, but verbal re-confirmation may be needed (per local regulations) at the time of randomization\].
Exclusion
- Non-emancipated minors (as per local regulations)
- 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 or documented in the medical record.
- Any use of azithromycin, erythromycin, or other macrolide in the 3 days or less prior to randomization.
- Plan for cesarean delivery prior to randomization.
- Preterm labor undergoing management with no immediate plan to proceed to delivery.
- 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.
- Are not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum hemorrhage) or mental disorder.
- Any other medical conditions that may be considered a contraindication per the judgment of the site investigator.
- Previous randomization in the trial.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
58747 Patients enrolled
Trial Details
Trial ID
NCT03871491
Start Date
September 1 2020
End Date
September 30 2022
Last Update
October 24 2024
Active Locations (8)
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1
ICDDRB
Dhaka, Bangladesh, 1212
2
Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
3
Institute for Nutrition of Central America and Panama (INCAP)
Guatemala City, Guatemala, 01011
4
Jawaharlal Nehru Medical College
Belagām, India, 590 010