Clinical Trials Logo

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
Est. primary completion date
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3