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

Primary Purpose

Infant, Newborn, Diseases, Sepsis, Puerperal Infection

Status

Unknown status

Phase

Phase 3

Locations

South Africa

Study Type

Interventional

Intervention

Chlorhexidine

Birth canal wipe

sterile water external genital wipe

About this trial

This is an interventional prevention trial for Infant, Newborn, Diseases focused on measuring Chlorhexidine, Prevention, Neonatal sepsis, Peripartum infections

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Chris Hani Baragwanath HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Chlorhexidine Vaginal Wipe

Sterile water external genital wipe

Outcomes

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

Full Information

NCT ID

NCT00136370

First Posted

August 25, 2005

Last Updated

September 21, 2007

Sponsor

Centers for Disease Control and Prevention

Collaborators

Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), National Vaccine Program Office

1. Study Identification

Unique Protocol Identification Number

NCT00136370

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Unknown status

Study Start Date

April 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), National Vaccine Program Office

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Newborn, Diseases, Sepsis, Puerperal Infection

Keywords

Chlorhexidine, Prevention, Neonatal sepsis, Peripartum infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Chlorhexidine Vaginal Wipe

Arm Title

Arm Type

Placebo Comparator

Arm Description

Sterile water external genital wipe

Intervention Type

Drug

Intervention Name(s)

Chlorhexidine

Intervention Type

Procedure

Intervention Name(s)

Birth canal wipe

Intervention Type

Procedure

Intervention Name(s)

sterile water external genital wipe

Primary Outcome Measure Information:

Title

Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life

Title

Rate of vertical transmission of colonization with group B streptococcus (GBS)

Secondary Outcome Measure Information:

Title

Rates of culture-confirmed or clinical neonatal sepsis (non-nosocomial), 3 to 28 days of life

Title

Rates of serious maternal per partum infections including: endometritis, culture-confirmed post-partum sepsis, and post-partum perineal wound infection

Title

Rates of neonatal hospitalization, < 3 days of life

Title

Rates of neonatal hospitalization, < 28 days of life

Title

Rates of neonatal hospitalization, suspected sepsis

Title

Rate of vertical transmission of colonization with E. coli or Klebsiella species

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clare Cutland, BSc, MBBCh

Phone

+27-11-989-9894

cutlandc@hivsa.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shabir Madhi, MD, PhD

Phone

+27-11-989-9894

madhis@hivsa.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Schrag, DPhil

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shabir Madhi, MD, PhD

Organizational Affiliation

Respiratory and Meningeal Pathogens Research Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chris Hani Baragwanath Hospital

City

Soweto

State/Province

Gauteng

Country

South Africa

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shabir Madhi, MD, PhD

Phone

+27-11-989-9894

madhis@hivsa.com

First Name & Middle Initial & Last Name & Degree

Clare Cutland, BSc, MBBCh

Phone

+27-11-989-9894

cutlandc@hivsa.com

First Name & Middle Initial & Last Name & Degree

Shabir Madhi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Clare Cutland, BSc, MBBCh

First Name & Middle Initial & Last Name & Degree

Sithembiso Velaphi, MB

12. IPD Sharing Statement

Citations:

PubMed Identifier

3891445

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. doi: 10.1016/0028-2243(85)90034-6.

Results Reference

background

PubMed Identifier

9253269

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. doi: 10.1136/bmj.315.7102.216.

Results Reference

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PubMed Identifier

2653894

Citation

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.

Results Reference

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PubMed Identifier

1352011

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. doi: 10.1016/0140-6736(92)90393-h.

Results Reference

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PubMed Identifier

7556834

Citation

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.

Results Reference

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PubMed Identifier

9077616

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. doi: 10.1016/s0002-9378(97)70557-x.

Results Reference

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PubMed Identifier

10461843

Citation

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.

Results Reference

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PubMed Identifier

12375548

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. doi: 10.1080/jmf.11.2.84.88.

Results Reference

background

PubMed Identifier

22869824

Citation

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.

Results Reference

derived

PubMed Identifier

22565291

Citation

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.

Results Reference

derived

PubMed Identifier

19846212

Citation

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.

Results Reference

derived

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

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