Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
NCT ID: NCT00136370
Last Updated: 2007-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
8000 participants
INTERVENTIONAL
2004-04-30
2007-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Chlorhexidine Vaginal Wipe
Chlorhexidine
Birth canal wipe
2
Sterile water external genital wipe
sterile water external genital wipe
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chlorhexidine
Birth canal wipe
sterile water external genital wipe
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Plan to deliver at Chris Hani Baragwanath Hospital or one of its satellite clinics
* Plan to remain in Soweto for at least two months after delivery
* Are able to understand and give informed consent
* Are at least 15 years old at time of registration
Exclusion Criteria
* Antenatal ultrasound revealing major fetal congenital anomalies
* Have known or suspected condition in which vaginal exams are contraindicated, e.g. placenta previa
* Have a history of allergic reaction to any topical antiseptic solution
* Present to labour ward with infant born before arrival
* Present to labour ward with significant vaginal bleeding during labour
* Present with known intrauterine fetal death prior to randomization
* Subject noted to be in full cervical dilatation or have baby's head on perineum
* Infant noted to be in face presentation on first vaginal examination
* Noted to have genital ulcers present on first vaginal examination
15 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bill and Melinda Gates Foundation
OTHER
United States Agency for International Development (USAID)
FED
National Vaccine Program Office
UNKNOWN
Centers for Disease Control and Prevention
FED
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephanie Schrag, DPhil
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention
Shabir Madhi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Respiratory and Meningeal Pathogens Research Unit
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shabir Madhi, MD, PhD
Role: primary
Clare Cutland, BSc, MBBCh
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Christensen KK, Christensen P, Dykes AK, Kahlmeter G. Chlorhexidine for prevention of neonatal colonization with group B streptococci. III. Effect of vaginal washing with chlorhexidine before rupture of the membranes. Eur J Obstet Gynecol Reprod Biol. 1985 Apr;19(4):231-6. doi: 10.1016/0028-2243(85)90034-6.
Taha TE, Biggar RJ, Broadhead RL, Mtimavalye LA, Justesen AB, Liomba GN, Chiphangwi JD, Miotti PG. Effect of cleansing the birth canal with antiseptic solution on maternal and newborn morbidity and mortality in Malawi: clinical trial. BMJ. 1997 Jul 26;315(7102):216-9; discussion 220. doi: 10.1136/bmj.315.7102.216.
Kollee LA, Speyer I, van Kuijck MA, Koopman R, Dony JM, Bakker JH, Wintermans RG. Prevention of group B streptococci transmission during delivery by vaginal application of chlorhexidine gel. Eur J Obstet Gynecol Reprod Biol. 1989 Apr;31(1):47-51. doi: 10.1016/0028-2243(89)90025-7.
Burman LG, Christensen P, Christensen K, Fryklund B, Helgesson AM, Svenningsen NW, Tullus K. Prevention of excess neonatal morbidity associated with group B streptococci by vaginal chlorhexidine disinfection during labour. The Swedish Chlorhexidine Study Group. Lancet. 1992 Jul 11;340(8811):65-9. doi: 10.1016/0140-6736(92)90393-h.
Adriaanse AH, Kollee LA, Muytjens HL, Nijhuis JG, de Haan AF, Eskes TK. Randomized study of vaginal chlorhexidine disinfection during labor to prevent vertical transmission of group B streptococci. Eur J Obstet Gynecol Reprod Biol. 1995 Aug;61(2):135-41. doi: 10.1016/0301-2115(95)02134-s.
Rouse DJ, Hauth JC, Andrews WW, Mills BB, Maher JE. Chlorhexidine vaginal irrigation for the prevention of peripartal infection: a placebo-controlled randomized clinical trial. Am J Obstet Gynecol. 1997 Mar;176(3):617-22. doi: 10.1016/s0002-9378(97)70557-x.
Stray-Pedersen B, Bergan T, Hafstad A, Normann E, Grogaard J, Vangdal M. Vaginal disinfection with chlorhexidine during childbirth. Int J Antimicrob Agents. 1999 Aug;12(3):245-51. doi: 10.1016/s0924-8579(99)00068-0.
Facchinetti F, Piccinini F, Mordini B, Volpe A. Chlorhexidine vaginal flushings versus systemic ampicillin in the prevention of vertical transmission of neonatal group B streptococcus, at term. J Matern Fetal Neonatal Med. 2002 Feb;11(2):84-8. doi: 10.1080/jmf.11.2.84.88.
Cutland CL, Schrag SJ, Zell ER, Kuwanda L, Buchmann E, Velaphi SC, Groome MJ, Adrian PV, Madhi SA; PoPS trial team. Maternal HIV infection and vertical transmission of pathogenic bacteria. Pediatrics. 2012 Sep;130(3):e581-90. doi: 10.1542/peds.2011-1548. Epub 2012 Aug 6.
Schrag SJ, Cutland CL, Zell ER, Kuwanda L, Buchmann EJ, Velaphi SC, Groome MJ, Madhi SA; PoPS Trial Team. Risk factors for neonatal sepsis and perinatal death among infants enrolled in the prevention of perinatal sepsis trial, Soweto, South Africa. Pediatr Infect Dis J. 2012 Aug;31(8):821-6. doi: 10.1097/INF.0b013e31825c4b5a.
Cutland CL, Madhi SA, Zell ER, Kuwanda L, Laque M, Groome M, Gorwitz R, Thigpen MC, Patel R, Velaphi SC, Adrian P, Klugman K, Schuchat A, Schrag SJ; PoPS Trial Team. Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial. Lancet. 2009 Dec 5;374(9705):1909-16. doi: 10.1016/S0140-6736(09)61339-8. Epub 2009 Oct 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
#U50 CCU021960, 02075
Identifier Type: -
Identifier Source: secondary_id
RFA CI05-059
Identifier Type: -
Identifier Source: secondary_id
CDC-NCID-3842
Identifier Type: -
Identifier Source: org_study_id