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| ID | Type | Description | Link |
|---|---|---|---|
| #U50 CCU021960, 02075 | |||
| RFA CI05-059 |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| United States Agency for International Development (USAID) | FED |
| National Vaccine Program Office | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Chlorhexidine Vaginal Wipe |
|
| 2 | Placebo Comparator | Sterile water external genital wipe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug |
| ||
| Birth canal wipe |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life | ||
| Rate of vertical transmission of colonization with group B streptococcus (GBS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clare Cutland, BSc, MBBCh | Contact | +27-11-989-9894 | cutlandc@hivsa.com | |
| Shabir Madhi, MD, PhD | Contact | +27-11-989-9894 | madhis@hivsa.com |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Schrag, DPhil | Centers for Disease Control and Prevention | Principal Investigator |
| Shabir Madhi, MD, PhD | Respiratory and Meningeal Pathogens Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chris Hani Baragwanath Hospital | Recruiting | Soweto | Gauteng | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3891445 | Background | 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. | |
| 9253269 | Background |
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| sterile water external genital wipe | Procedure |
|
| 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 |
| 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. |
| 2653894 | Background | 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. |
| 1352011 | Background | 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. |
| 7556834 | Background | 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. |
| 9077616 | Background | 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. |
| 10461843 | Background | 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. |
| 12375548 | Background | 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. |
| 22869824 | Derived | 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. |
| 22565291 | Derived | 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. |
| 19846212 | Derived | 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. |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D018805 | Sepsis |
| D011645 | Puerperal Infection |
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011251 | Pregnancy Complications, Infectious |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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