Clindamycin to Reduce Preterm Birth in a Low Resource Setting

NCT01800825 | Completed Phase 4 DMC

• 1 other identifier: Thrasher (DDD# 601465)
• Study Type: interventional
• Target: 1,726
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Pregnancy; Prematurity; Preterm Birth; Bacterial Vaginosis

Keywords

Pregnancy; Prematurity; Preterm birth; bacterial vaginosis

Outcome Measures

Primary Outcomes (1)

• Preterm birth prior to 37 weeks

  Preterm birth prior to 37 weeks

  Time of birth

Secondary Outcomes (7)

• Preterm birth prior to 34 weeks

  Time of birth

• Late Miscarriage

  Time of delivery

• Low Birth weight

  Time of delivery

• Very Low birth Weight

  Time of delivery

• Neonatal complications through 42 days after delivery

  42 days post delivery

Other Outcomes (3)

• neonatal mortality

  Time of delivery

• maternal and neonatal complications through 42 days postpartum,

  42 days postpartum

• Incremental cost of preventing preterm birth

  42 days postpartum

Study Arms (2)

Clindamycin

ACTIVE COMPARATOR

Clindamycin 300mg orally twice daily for five days

Drug: Clindamycin

placebo

PLACEBO COMPARATOR

This will be an identical placebot

Drug: Placebo

Interventions

Clindamycin DRUG

Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days

Also known as: Cleocin

Clindamycin

Placebo DRUG

This will be an identical placebo comparator made of starch.

placebo

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a singleton Intrauterine pregnancy between 13-20 weeks
• Maternal age of 18 or older or if \< 18 assent of the women's parent/guardian
• Vaginal PH \> 5.0

You may not qualify if:

• Use of antibiotics within the 14 days prior to randomization
• Known sensitivity to antibiotics
• Uterine anomalies
• Major fetal anomalies
• Medical conditions that may result in iatrogenic prematurity(e.g.diabetes, Lupus, Hypertension)

Sponsors & Collaborators

• Christiana Care Health Services: lead
• Jawaharlal Nehru Medical College: collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Jawaharlal Nehru Medical College

Belagavi, Karnataka, India

Location

Related Publications (15)

• 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.

  PMID: 22071048 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.

  PMID: 12660054 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.

  PMID: 15752534 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.

  PMID: 21496911 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.

  PMID: 18177778 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.

  PMID: 12763112 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.

  PMID: 7491136 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.

  PMID: 18973872 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.

  PMID: 17253447 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.

  PMID: 7503196 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.

  PMID: 10684919 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.

  PMID: 12969574 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.

  PMID: 11117774 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.

  PMID: 11339909 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.

  PMID: 17346476 BACKGROUND

Related Links

• Thrasher Foundation

MeSH Terms

Conditions

Premature Birth; Vaginosis, Bacterial

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Matthew K Hoffman, MD MPH

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 28, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

IN (1)