Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn

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ClinicalTrials.gov Identifier: NCT00136370

Recruitment Status : Unknown

Verified September 2007 by Centers for Disease Control and Prevention.
Recruitment status was: Recruiting

First Posted : August 29, 2005

Last Update Posted : September 24, 2007

Sponsor:

Collaborators:

Bill and Melinda Gates Foundation

United States Agency for International Development (USAID)

National Vaccine Program Office

Information provided by:

Centers for Disease Control and Prevention

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infant, Newborn, Diseases Sepsis Puerperal Infection	Drug: Chlorhexidine Procedure: Birth canal wipe Procedure: sterile water external genital wipe	Phase 3

Detailed Description:

We are conducting a randomized, controlled clinical trial in Soweto, South Africa to evaluate the efficacy of 0.5% 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	8000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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
Study Start Date :	April 2004
Estimated Study Completion Date :	November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Drug Information available for: Chlorhexidine Chlorhexidine acetate Chlorhexidine hydrochloride Chlorhexidine gluconate Hibiclens

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Chlorhexidine Vaginal Wipe	Drug: Chlorhexidine Procedure: Birth canal wipe
Placebo Comparator: 2 Sterile water external genital wipe	Procedure: sterile water external genital wipe

Outcome Measures

Primary Outcome Measures :

Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
Rate of vertical transmission of colonization with group B streptococcus (GBS)

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	15 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant
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:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136370

Contacts

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Contact: Clare Cutland, BSc, MBBCh	+27-11-989-9894	cutlandc@hivsa.com
Contact: Shabir Madhi, MD, PhD	+27-11-989-9894	madhis@hivsa.com

Locations

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South Africa
Chris Hani Baragwanath Hospital	Recruiting
Soweto, Gauteng, South Africa
Contact: Shabir Madhi, MD, PhD +27-11-989-9894 madhis@hivsa.com
Contact: Clare Cutland, BSc, MBBCh +27-11-989-9894 cutlandc@hivsa.com
Principal Investigator: Shabir Madhi, MD, PhD
Sub-Investigator: Clare Cutland, BSc, MBBCh
Sub-Investigator: Sithembiso Velaphi, MB

Sponsors and Collaborators

Centers for Disease Control and Prevention

Bill and Melinda Gates Foundation

United States Agency for International Development (USAID)

National Vaccine Program Office

Investigators

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Principal Investigator:	Stephanie Schrag, DPhil	Centers for Disease Control and Prevention
Principal Investigator:	Shabir Madhi, MD, PhD	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.

Kollée 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, Kollée 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, Grøgaard 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 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.

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ClinicalTrials.gov Identifier:	NCT00136370
Other Study ID Numbers:	CDC-NCID-3842 #U50 CCU021960, 02075 RFA CI05-059
First Posted:	August 29, 2005 Key Record Dates
Last Update Posted:	September 24, 2007
Last Verified:	September 2007

Keywords provided by Centers for Disease Control and Prevention:


Chlorhexidine Prevention Neonatal sepsis Peripartum infections

Additional relevant MeSH terms:

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Infection Communicable Diseases Sepsis Puerperal Infection Infant, Newborn, Diseases Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes	Pregnancy Complications, Infectious Pregnancy Complications Puerperal Disorders Chlorhexidine Anti-Infective Agents, Local Anti-Infective Agents Disinfectants

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