| Trial name or title |
Randomized pilot trial of chlorhexidine vaginal and infant wash to reduce neonatal mortality. |
| Methods |
|
| Participants |
Healthy female volunteers aged 16 years and above. Expected total enrolment: 1000. Setting: civil hospital in Karachi, Pakistan. |
| Interventions |
0.6% chlorhexidine solution every 4 hours until delivery (4 washes maximum) and 1 neonatal wash with the same solution compared with 200 mL of sterile physiologic saline solution. |
| Outcomes |
Primary outcomes: neonatal death or severe sepsis at 7 days.
Secondary outcomes: maternal: clinical chorioamnionitis, clinical endometritis, urinary tract infection, sepsis, length of hospitalization, readmission to hospital, death; neonatals: receipt of antibiotics, duration of hospitalization, readmission to hospital |
| Starting date |
June 2005. |
| Contact information |
Nancy Moss: mossn@mail.nih.gov |
| Notes |
Expected completion date: June 2006.
ClinicalTrials.gov identifier NCT00121394
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