PACTR202004580322097
Recruiting
Phase 4
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 sites4,250 target enrollmentMarch 13, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Enrollment
- 4250
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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].
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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