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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00136370
• Other study ID #: CDC-NCID-3842
• Secondary ID: #U50 CCU021960,
• Status: Recruiting
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: September 21, 2007
• Start date: April 2004
• Est. completion date: November 2007

Study information

• Verified date: September 2007
• Source: Centers for Disease Control and Prevention
• Contact: Clare Cutland, BSc, MBBCh
• Phone: +27-11-989-9894
• Email: cutlandc[@]hivsa.com
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSouth Africa: University of Witwatersrand Human Research Ethics Committee (Medical)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Infection
• Puerperal Infection
• Sepsis

Intervention

Drug:
• Chlorhexidine

Procedure:
• Birth canal wipe

• sterile water external genital wipe

Locations

Country	Name	City	State
South Africa	Chris Hani Baragwanath Hospital	Soweto	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Bill and Melinda Gates Foundation, National Vaccine Program Office, United States Agency for International Development (USAID)

Country where clinical trial is conducted

South Africa, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life
Primary	Rate of vertical transmission of colonization with group B streptococcus (GBS)
Secondary	Rates of culture-confirmed or clinical neonatal sepsis (non-nosocomial), 3 to 28 days of life
Secondary	Rates of serious maternal per partum infections including: endometritis, culture-confirmed post-partum sepsis, and post-partum perineal wound infection
Secondary	Rates of neonatal hospitalization, < 3 days of life
Secondary	Rates of neonatal hospitalization, < 28 days of life
Secondary	Rates of neonatal hospitalization, suspected sepsis
Secondary	Rate of vertical transmission of colonization with E. coli or Klebsiella species