Blood samples are collected from some infants for measurement of chlorhexidine levels approximately 2 hours post-washing. During the 24 to 48 hours following delivery, infants are examined and mothers are queried using standardized questionnaires for subjective complaints related to the chlorhexidine washes. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
Have gestation of at least 36 weeks using EGA and estimation of height of uterine fundus on physical exam. Be receiving routine prenatal care at the Chris Hani Baragwanath Hospital maternity unit in Soweto, South Africa. Prostaglandin tablets administered intravaginally at presentation in labor. An elective or planned C-section. Obvious genital ulcerations at the time of presentation in labor.