Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136370
Status:
UNKNOWN
Last Update Posted:
2007-09-24
First Post:
2005-08-25
Brief Title:
Prevention of Perinatal Sepsis PoPS Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Preventing Serious Neonatal and Maternal Peripartum Infections in Developing Country Settings With a High Prevalence of HIV Infection Assessment of the Disease Burden and Evaluation of an Affordable Intervention in Soweto South Africa
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
RECRUITING
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 evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth If effective this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries
Detailed Description:
We are conducting a randomized controlled clinical trial in Soweto South Africa to evaluate the efficacy of 05 chlorhexidine wipes of the birth canal during labour and of the infant at birth in reducing 1 vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery and 2 incidence of neonatal sepsis and maternal peripartum infection in comparison to external genitalia sterile water wipes In conjunction with this we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among HIV-infected and non-infected pregnant women who deliver at the only public hospital in Soweto and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RFA CI05-059 | None | None | None |
| U50 CCU021960 02075 | None | None | None |