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Clinical Trial: Prevention of Perinatal Sepsis (PoPS). Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn.
This study is currently recruiting patients.
Verified by Centers for Disease Control and Prevention August 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Infant, Newborn, Diseases Sepsis Puerperal Infection | Drug: Chlorhexidine Procedure: Birth Canal Wipe | Phase III |
MedlinePlus related topics: High Risk Pregnancy; Infant and Toddler Health; Infections and Pregnancy; Sepsis
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.
Secondary Outcomes: Rates of Culture-confirmed or clinical neonatal sepsis (non-nosocomial), 3 to 28 days of life; Rates of Serious maternal per partum infections including: Endometritis, Culture-confirmed post-partum sepsis, and Post-partum Perineal Wound Infection; Rates of neonatal hospitalization, < 3 days of life; Rates of neonatal hospitalization, < 28 days of life; Rates of neonatal hospitalization, suspected sepsis; Rate of Vertical transmission of colonization with E. coli or Klebsiella species
Expected Total Enrollment: 8000
Study start: April 2004; Expected completion: May 2008
Last follow-up: August 2007; Data entry closure: November 2007
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- Pregnant
- Plan to deliver at Chris Hani Baragwanath Hospital or one of it’s 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:
- Planned delivery by caesarean section
- 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
Location and Contact Information
Shabir Madhi, MD, PhD +27-11-989-9894 madhis@hivsa.com
South Africa, Gauteng
Chris Hani Baragwanath Hospital, Soweto, Gauteng, South Africa; Recruiting
Clare Cutland, BSc, MBBCh +27-11-989-9894 cutlandc@hivsa.com
Shabir Madhi, MD, PhD, Principal Investigator
Clare Cutland, BSc, MBBCh, Sub-Investigator
Sithembiso Velaphi, MB, Sub-Investigator
Stephanie Schrag, DPhil, Principal Investigator, Centers for Disease Control and Prevention
Shabir Madhi, MD, PhD, Principal Investigator, Respiratory and Meningeal Pathogens Research Unit
More Information
Publications
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.
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.
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.
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.
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.
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.
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.
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.
Last Updated: August 26, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00136370
Health Authority: United States: Federal Government; South Africa: University of Witwatersrand Human Research Ethics Committee (Medical)
ClinicalTrials.gov processed this record on 2005-08-30
Resources
- American Academy of Pediatrics
- Fat on Formula: The Story Behind Infant Formula Supplemented with Lipids and Mental Development (American Academy of Pediatrics)
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