Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006075
Status:
COMPLETED
Last Update Posted:
2008-09-30
First Post:
2000-07-27
Brief Title:
A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase IIA Study of Tolerance and Safety of Differing Concentrations of Chlorhexidine for Peripartum Vaginal and Infant Washes to Prevent Mother to Infant HIV-1 Transmission
Status:
COMPLETED
Status Verified Date:
2004-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find the best strength of chlorhexidine a solution that kills germs for washing the mothers vagina during labor and the newborn baby that may reduce the chance of HIV being passed from an HIV-positive mother to the baby
When used as a wash on the vagina during labor and on a newborn shortly after birth a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV
When used as a wash on the vagina during labor and on a newborn shortly after birth a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV
Detailed Description:
The principal hypothesis of this protocol is that in the context of routine oralnasal suctioning of infants a higher concentration of chlorhexidine for peripartum vaginal and postpartum newborn cleansing results in reduction in maternal child transmission MCT of HIV The in vitro data suggest that a higher concentration of chlorhexidine in the primary wash solution is much more likely to have a virucidal effect perinatally and thus reduce MCT
Perinatal intervention consists of the following 1 cervicovaginal wash of the entire birth canal with a chlorhexidine solution at the time of each vaginal examination of a mother in labor 2 immediate suctioning of the nasal and oral passages of the infant at the time the head emerges fluids to be tested for viral load at future date and 3 thorough washing of the baby with a chlorhexidine solution immediately after delivery 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 Speculum-aided vaginal exams are done for any persistent greater than 24 hours or severe complaints
Perinatal intervention consists of the following 1 cervicovaginal wash of the entire birth canal with a chlorhexidine solution at the time of each vaginal examination of a mother in labor 2 immediate suctioning of the nasal and oral passages of the infant at the time the head emerges fluids to be tested for viral load at future date and 3 thorough washing of the baby with a chlorhexidine solution immediately after delivery 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 Speculum-aided vaginal exams are done for any persistent greater than 24 hours or severe complaints
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: