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| Name | Class |
|---|---|
| Jawaharlal Nehru Medical College | OTHER |
| Thrasher Research Fund | OTHER |
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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)
The primary study objective is to definitively test whether 300 mg oral clindamycin two times per day for 5-days administered at 13-20 weeks of gestation in women with a vaginal pH≥5 reduces the incidence of preterm delivery in Karnataka, India by at least 30%. The national incidence of gestation <37 weeks in India is 14.5%, was 18% in the study area in 2011 and was 20% among women with vaginal pH≥5 in the recently completed Jawaharlal Nehru Medical Collage (JNMC) hospital-based study of clindamycin to reduce preterm birth. Using a two tailed test, α=0.05, 1-β=80%, a 17.5% rate of prematurity in women with vaginal pH≥5, a 2.5% refusal and a 7.5% loss to follow-up, assuming 86% of women presenting for antenatal care are 13-20 weeks gestation and 1% otherwise ineligible, and a multiple comparisons adjustment, 1,726 women, half in the clindamycin and half in the placebo group, need to be enrolled to test the primary hypothesis. The effects of clindamycin on spontaneous preterm birth, miscarriage, low birthweight (LBW), neonatal mortality (NMR), maternal and neonatal complications through 42 days postpartum, the utility of vaginal pH≥5 to identify women at risk for preterm delivery and the costs of preterm birth prevented by oral clindamycin treatment and compliance with the 5-day treatment regimen will also be assessed. This will be the first investigation to test whether oral clindamycin prevents preterm birth in a community-based, developing country setting, where most global newborn deaths occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin | Active Comparator | Clindamycin 300mg orally twice daily for five days |
|
| placebo | Placebo Comparator | This will be an identical placebot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin | Drug | Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth prior to 37 weeks | Preterm birth prior to 37 weeks | Time of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm birth prior to 34 weeks | Preterm birth prior to 34 weeks | Time of birth |
| Late Miscarriage | miscarriage between 16-20 weeks | Time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| neonatal mortality | neonatal mortality | Time of delivery |
| maternal and neonatal complications through 42 days postpartum, | maternal and neonatal complications through 42 days postpartum, |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew K Hoffman, MD MPH | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Nehru Medical College | Belagavi | Karnataka | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22071048 | 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. | |
| 12660054 |
| Label | URL |
|---|---|
| Thrasher Foundation | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2022 | |
| Reset | Mar 15, 2023 | |
| Release | Apr 6, 2023 | |
| Reset | Jan 10, 2024 | |
| Release | Feb 5, 2024 | |
| Reset | Jul 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2022 | Mar 15, 2023 | |||
| Apr 6, 2023 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | This will be an identical placebo comparator made of starch. |
|
| Low Birth weight | Birth Weight< 2500 gm | Time of delivery |
| Very Low birth Weight | Very Low birth Weight is birthweight <1500gm | Time of delivery |
| Neonatal complications through 42 days after delivery | Neonatal complications through 42 days after delivery (to assess benefit or no harm) | 42 days post delivery |
| Maternal complications through 42 days postpartum | Maternal complications through 42 days postpartum (to assess benefit or no harm) | 42 days post delivery |
| The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery | The utility of vaginal pH tests for identification of women at elevated risk for preterm delivery | Time of delivery |
| 42 days postpartum |
| Incremental cost of preventing preterm birth | Determine the costs of preventing preterm birth | 42 days postpartum |
| 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. |
| 15752534 | 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. |
| 21496911 | 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. |
| 18177778 | 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. |
| 12763112 | 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. |
| 7491136 | 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. |
| 18973872 | 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. |
| 17253447 | 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. |
| 7503196 | 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. |
| 10684919 | 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. |
| 12969574 | 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. |
| 11117774 | 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. |
| 11339909 | 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. |
| 17346476 | 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. |
| Jan 10, 2024 |
| Feb 5, 2024 | Jul 17, 2024 |
| D000091642 | Urogenital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |