Phase 4
N=756
Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries
Postpartum Sepsis · Postpartum Endometritis · Postpartum Fever
Bottom Line
View on ClinicalTrials.gov: NCT03248297 ↗Enrolled (actual)
756
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Number of Participants Who Experienced Composite Peripartum Infection or Death — 15; 17; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin (Drug); Azithromycin and amoxicillin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Composite Peripartum Infection or Death |
15; 17; 24 | — |
| SECONDARY Number of Participants Who Experienced Pyelonephritis |
2; 2; 3 | — |
| SECONDARY Number of Participants Who Experienced Breast Infection |
2; 0; 0 | — |
| SECONDARY Number of Participants Who Experienced Other Infection |
4; 3; 1 | — |
| SECONDARY Number of Participants Who Experienced Fever |
22; 21; 28 | — |
| SECONDARY Number of Participants Who Experienced Hypothermia |
9; 11; 15 | — |
| SECONDARY Number of Participants Who Needed PP Antibiotic |
18; 18; 26 | — |
| SECONDARY Number of Participants Who Experienced Transfusion |
8; 3; 4 | — |
| SECONDARY Number of Participants Who Experienced Stillbirth |
1; 0; 1 | — |
| SECONDARY Length of Stay |
3.7; 3.7; 3.8 | — |
| SECONDARY Number of Participants Who Experienced a Clinic Visit |
13; 7; 10 | — |
| SECONDARY Number of Participants Who Experienced a Maternal Readmission |
11; 4; 5 | — |
Summary
This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.
Eligibility Criteria
Inclusion Criteria
- Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with
- Prolonged membrane rupture (≥8 hours) or
- Prolonged labor (≥18 hours).
Exclusion Criteria
- Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.
- Allergy to azithromycin or amoxicillin
- Plan for cesarean delivery prior to enrollment
- Fetal demise or major congenital anomaly: Major congenital anomalies may confound assessment of neonatal outcomes and every attempt will be made up front to exclude them from randomization. However, some unrecognized fetal anomalies may inevitably be randomized. These will not be excluded post-randomization from the primary (maternal outcome) analysis; they will be taken into consideration in the secondary analyses of neonatal outcomes.
Data sourced from ClinicalTrials.gov (NCT03248297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.