Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn - Full Text View

Sponsor:	Centers for Disease Control and Prevention
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
ClinicalTrials.gov Identifier:	NCT00136370

Purpose

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	Intervention	Phase
Infant, Newborn, Diseases Sepsis Puerperal Infection	Drug: Chlorhexidine Procedure: Birth canal wipe Procedure: sterile water external genital wipe	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care Sepsis

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

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

Estimated Enrollment:	8000
Study Start Date:	April 2004
Estimated Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Experimental Chlorhexidine Vaginal Wipe	Drug: Chlorhexidine Procedure: Birth canal wipe
2: Placebo Comparator Sterile water external genital wipe	Procedure: sterile water external genital wipe

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136370

Contacts

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

South Africa, Gauteng
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

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.

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.

Study ID Numbers:	CDC-NCID-3842, #U50 CCU021960, 02075, RFA CI05-059
Study First Received:	August 25, 2005
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00136370 History of Changes
Health Authority:	United States: Federal Government; South Africa: University of Witwatersrand Human Research Ethics Committee (Medical)

Keywords provided by Centers for Disease Control and Prevention:

Chlorhexidine
Prevention
Neonatal sepsis
Peripartum infections

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Communicable Diseases
Pregnancy Complications
Chlorhexidine
Pregnancy Complications, Infectious
Infection
Pharmacologic Actions
Inflammation
Anti-Infective Agents, Local

Disinfectants
Sepsis
Pathologic Processes
Puerperal Infection
Puerperal Disorders
Chlorhexidine gluconate
Therapeutic Uses
Infant, Newborn, Diseases
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009