Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Pregnancy Clinical Trial

Official title:

Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800825
• Other study ID #: Thrasher (DDD# 601465)
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2013
• Last updated: July 15, 2016
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1726
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Pregnancy
• Premature Birth
• Prematurity
• Preterm Birth
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Clindamycin
Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
• Placebo
This will be an identical placebo comparator made of starch.

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College	Belgaum	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Christiana Care Health Services	Jawaharlal Nehru Medical College, Thrasher Research Fund

Country where clinical trial is conducted

India, 

References & Publications (15)

Friese K. The role of infection in preterm labour. BJOG. 2003 Apr;110 Suppl 20:52-4. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Kekki M, Kurki T, Pelkonen J, Kurkinen-Räty 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. — View Citation

Kurkinen-Räty 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. — View Citation

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. Review. — View Citation

Lamont RF. Antibiotics for the prevention of preterm birth. N Engl J Med. 2000 Feb 24;342(8):581-3. — View Citation

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. — View Citation

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. — View Citation

McDonald HM, Brocklehurst P, Gordon A. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000262. Review. Update in: Cochrane Database Syst Rev. 2013;1:CD000262. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neonatal mortality	neonatal mortality	Time of delivery	Yes
Other	maternal and neonatal complications through 42 days postpartum,	maternal and neonatal complications through 42 days postpartum,	42 days postpartum	Yes
Other	Incremental cost of preventing preterm birth	Determine the costs of preventing preterm birth	42 days postpartum	No
Primary	Preterm birth prior to 37 weeks	Preterm birth prior to 37 weeks	Time of birth	No
Secondary	Preterm birth prior to 34 weeks	Preterm birth prior to 34 weeks	Time of birth	No
Secondary	Late Miscarriage	miscarriage between 16-20 weeks	Time of delivery	No
Secondary	Low Birth weight	Birth Weight< 2500 gm	Time of delivery	No
Secondary	Very Low birth Weight	Very Low birth Weight is birthweight <1500gm	Time of delivery	No
Secondary	Neonatal complications through 42 days after delivery	Neonatal complications through 42 days after delivery (to assess benefit or no harm)	42 days post delivery	Yes
Secondary	Maternal complications through 42 days postpartum	Maternal complications through 42 days postpartum (to assess benefit or no harm)	42 days post delivery	Yes
Secondary	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	No

External Links

•   Thrasher Foundation