Table 1.
Summary of selected vaginal/neonatal chlorhexidine studies aimed at improving pregnancy outcomes in low-resource settings
| Author, Year | Location | Study design, sample size | Study Groups | Outcome |
|---|---|---|---|---|
| Bakr 2005 | Egypt | Pre-post comparison, N = 4415 | Manual wiping of birth canal with 0.25% CHX solution; babies wiped | Neonatal admissions were comparable, the nonintervention group showed a significantly higher rate of admissions due to sepsis (p=0.0002) and deaths caused by sepsis (0.004). |
| Taha 1997 | Malawi | Pre-post comparison, N = 6965 | Vaginal wipe with0.25% CHX; babies wiped. | Intervention phase, overall neonatal admissions were reduced (634/3743 (16.9%) v 661/3417(19.3%), P<0.01), as were admissions for neonatal sepsis (7.8 v 17.9 per 1000 live births, P<0.0002), overall neonatal mortality (28.6 v 36.9 per 1000 live births, P<0.06), and mortality due to infectious causes (2.4 v 7.3 per 1000 live births, P<0.005). |
| Mullany 2006 | Nepal | Cluster randomized, placebo controlled trial, N = 15,855 | 4.0% CHX, soap and water on days 1,2,3,4,6,8,10 or dry cord care | 75% reduction in severe cord infection (95% CI0.12,0.53) |
| Tielsch 2005 | Nepal | Cluster randomized, placebo controlled trial, N = 15,855 | Neonatal wipe with normal wipes or wipes with 0.25% CHX solution after delivery. | Overall, no significant effect, but in a secondary analysis, a 28% reduction in mortality among low birth weight infants (RR=0.72, CI: 0.54, 0.95) and no impact on infants 2500 g or above (RR=1.14, CI: 0.75, 1.73). |
| Studies in the field or not yet reported | ||||
| Goldenberg | Pakistan | Randomized, placebo controlled trial, Planned N = 5000 | Intrapartum vaginal wipe with 0.6% CHX, babies wiped | 28-day neonatal mortality, infection-related morbidity |
| Schrag | South Africa | Randomized trial, Planned N = 8000 | Intrapartum vaginal wash with 0.5% CHX, babies wiped | Infection-related hospitalization |
| Tolosa, Chipato | Zimbabwe | Pilot study, N = 500 | Intrapartum vaginal wash with 1% CHX, babies wiped | Safety and feasibility of 1% CHX washing of the vaginal canal and neonate. Change in vaginal flora related to CHX wash. |