AzTrials
AzTrials

PregnancyPhase 4NCT01800825

Clindamycin to Reduce Preterm Birth in a Low Resource Setting

A Phase 4 study testing Clindamycin in people with Pregnancy and Prematurity, run by Christiana Care Health Services at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 years and older, women only
Conditions the study is for
Pregnancy, Prematurity, Preterm Birth
What is being tested?
Clindamycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,726 participants
Where
1 siteIndia
Study dates
Jul 2013to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

India1 site

  • Jawaharlal Nehru Medical College

    Belagavi, Karnataka

Other trials in India

About this study

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

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)

Read the detailed 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.

Being tested
Clindamycin, Placebo
Keywords
Pregnancy, Prematurity, Preterm birth, bacterial vaginosis
Medical subject headings
Premature Birth, Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClindamycinDrug

    Also called Cleocin

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

  • PlaceboDrug

    This will be an identical placebo comparator made of starch.

Study groups in NCT01800825
Study groupRoleWhat they receive
ClindamycinActive comparatorClindamycin 300mg orally twice daily for five days
Receives: Drug: Clindamycin
placeboPlacebo comparatorThis will be an identical placebot
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm birth prior to 37 weeks

    Preterm birth prior to 37 weeks

    Measured: Time of birth

Secondary outcomes (7)

  1. Preterm birth prior to 34 weeks

    Preterm birth prior to 34 weeks

    Measured: Time of birth

  2. Late Miscarriage

    miscarriage between 16-20 weeks

    Measured: Time of delivery

  3. Low Birth weight

    Birth Weight< 2500 gm

    Measured: Time of delivery

  4. Very Low birth Weight

    Very Low birth Weight is birthweight <1500gm

    Measured: Time of delivery

  5. Neonatal complications through 42 days after delivery

    Neonatal complications through 42 days after delivery (to assess benefit or no harm)

    Measured: 42 days post delivery

  6. Maternal complications through 42 days postpartum

    Maternal complications through 42 days postpartum (to assess benefit or no harm)

    Measured: 42 days post delivery

  7. 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

    Measured: Time of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,726 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01800825
Sponsor's protocol ID
Thrasher (DDD# 601465)
Status last verified
Jul 2016
First submitted
20 Feb 2013
Last updated
18 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22071048

  • 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.

    PubMed 12660054

  • 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.

    PubMed 15752534

  • 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.

    PubMed 21496911

  • 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.

    PubMed 18177778

  • 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.

    PubMed 12763112

  • 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.

    PubMed 7491136

  • 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.

    PubMed 18973872

  • 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.

    PubMed 17253447

  • 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.

    PubMed 7503196

  • 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.

    PubMed 10684919

  • 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.

    PubMed 12969574

  • 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.

    PubMed 11117774

  • 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.

    PubMed 11339909

  • 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.

    PubMed 17346476

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clindamycin in people with Pregnancy and Prematurity, run by Christiana Care Health Services at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm birth prior to 37 weeks (time frame: Time of birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01800825, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.

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