Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Summary

Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)

Timeline

Start

2013-07

Primary completion

2016-04

Completion

2016-04

Publications

• Background Lamont RF, Nhan-Chang CL, Sobel JD, Workowski K, Conde-Agudelo A, Romero R. Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysis. Am J Obstet Gynecol. 2011 Sep;205(3):177-90. doi: 10.1016/j.ajog.2011.03.047. Epub 2011 Apr 2.
• Background Ugwumadu A, Manyonda I, Reid F, Hay P. Effect of early oral clindamycin on late miscarriage and preterm delivery in asymptomatic women with abnormal vaginal flora and bacterial vaginosis: a randomised controlled trial. Lancet. 2003 Mar 22;361(9362):983-8. doi: 10.1016/S0140-6736(03)12823-1.
• Background Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
• Background Lawn JE, Blencowe H, Pattinson R, Cousens S, Kumar R, Ibiebele I, Gardosi J, Day LT, Stanton C; Lancet's Stillbirths Series steering committee. Stillbirths: Where? When? Why? How to make the data count? Lancet. 2011 Apr 23;377(9775):1448-63. doi: 10.1016/S0140-6736(10)62187-3. Epub 2011 Apr 13.
• Background Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
• Background Friese K. The role of infection in preterm labour. BJOG. 2003 Apr;110(Suppl 20):52-4. doi: 10.1016/s1470-0328(03)00025-9.
• Background Hauth JC, Goldenberg RL, Andrews WW, DuBard MB, Copper RL. Reduced incidence of preterm delivery with metronidazole and erythromycin in women with bacterial vaginosis. N Engl J Med. 1995 Dec 28;333(26):1732-6. doi: 10.1056/NEJM199512283332603.
• Background Hutzal CE, Boyle EM, Kenyon SL, Nash JV, Winsor S, Taylor DJ, Kirpalani H. Use of antibiotics for the treatment of preterm parturition and prevention of neonatal morbidity: a metaanalysis. Am J Obstet Gynecol. 2008 Dec;199(6):620.e1-8. doi: 10.1016/j.ajog.2008.07.008. Epub 2008 Oct 30.
• Background McDonald HM, Brocklehurst P, Gordon A. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000262. doi: 10.1002/14651858.CD000262.pub3.
• Background Joesoef MR, Hillier SL, Wiknjosastro G, Sumampouw H, Linnan M, Norojono W, Idajadi A, Utomo B. Intravaginal clindamycin treatment for bacterial vaginosis: effects on preterm delivery and low birth weight. Am J Obstet Gynecol. 1995 Nov;173(5):1527-31. doi: 10.1016/0002-9378(95)90644-4.
• Background Lamont RF. Antibiotics for the prevention of preterm birth. N Engl J Med. 2000 Feb 24;342(8):581-3. doi: 10.1056/NEJM200002243420810. No abstract available.
• Background Guaschino S, Ricci E, Franchi M, Frate GD, Tibaldi C, Santo DD, Ghezzi F, Benedetto C, Seta FD, Parazzini F. Treatment of asymptomatic bacterial vaginosis to prevent pre-term delivery: a randomised trial. Eur J Obstet Gynecol Reprod Biol. 2003 Oct 10;110(2):149-52. doi: 10.1016/s0301-2115(03)00107-6.
• Background Kurkinen-Raty M, Vuopala S, Koskela M, Kekki M, Kurki T, Paavonen J, Jouppila P. A randomised controlled trial of vaginal clindamycin for early pregnancy bacterial vaginosis. BJOG. 2000 Nov;107(11):1427-32. doi: 10.1111/j.1471-0528.2000.tb11660.x.
• Background Kekki M, Kurki T, Pelkonen J, Kurkinen-Raty M, Cacciatore B, Paavonen J. Vaginal clindamycin in preventing preterm birth and peripartal infections in asymptomatic women with bacterial vaginosis: a randomized, controlled trial. Obstet Gynecol. 2001 May;97(5 Pt 1):643-8. doi: 10.1016/s0029-7844(01)01321-7.
• Background Morency AM, Bujold E. The effect of second-trimester antibiotic therapy on the rate of preterm birth. J Obstet Gynaecol Can. 2007 Jan;29(1):35-44. doi: 10.1016/s1701-2163(16)32350-7.

Drugs

Indications