Phase 3
N=39,679
Zambia Chlorhexidine Application Trial
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT01241318 ↗Enrolled (actual)
39,679
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: All-cause Neonatal Mortality — 282; 263; 18168; 19045 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chlorhexidine gluconate (4%) (Drug); Dry cord care (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Neonatal Mortality |
282; 263; 18168; 19045 | — |
| PRIMARY All-cause Neonatal Mortality Among Newborns Who Survived at Least First Day of Life |
200; 186; 18224; 19080 | — |
| SECONDARY Incidence of Omphalitis |
82; 118; 18428; 19228 | — |
| SECONDARY Place of Delivery |
6509; 6682; 11456; 12204; 190; 128 | — |
| SECONDARY Factors Influencing Delivery Location |
3198; 2082; 12991; 5693; 1823; 1249 | — |
| SECONDARY Health Facility Characteristics |
6; 94 | — |
Summary
This will be a cluster-randomized controlled trial to assess whether washing the umbilical cord with a disinfectant (4% chlorhexidine) helps to reduce neonatal deaths in Zambia when compared to the current standard of care, dry cord care.
Eligibility Criteria
Inclusion Criteria
- Pregnant women in the 2nd or 3rd trimester
- Age 15 years and above
- Pregnant women who plan to stay in the study area (catchment area of the health facility) for delivery and one month post partum
- Willingness to provide cord care as per the protocol of their cluster
- Willingness to provide informed consent
Exclusion Criteria
- Pregnant women who are not willing to provide cord care as per the protocol of their cluster
- Pregnant women who are not willing to provide informed consent
- Pregnant women in the 1st trimester
- Pregnant women under age 15 years
Data sourced from ClinicalTrials.gov (NCT01241318). 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.