Azithromycin-Prevention in Labor Use Study (A-PLUS)

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

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. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Aga Khan University; Bill and Melinda Gates Foundation; Boston University; Columbia University; INCAP, Guatemala; Indiana University School of Medicine; Institute of Nutrition of Central America and Panama; International Centre for Diarrhoeal Disease Research, Bangladesh; Kinshasa School of Public Health; KLE University's J N Medical College; KLE University's Jawaharlal Nehru Medical College; Lata Medical Research Foundation; Lata Medical Research Foundation, Nagpur; Moi Univeristy; RTI International; Thomas Jefferson University; University of Alabama at Birmingham; University of Colorado, Denver; University of North Carolina, Chapel Hill; University of Virginia; University Teaching Hospital, Lusaka, Zambia
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.