Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis

NCT00642980

Last updated date
Study Location
Hopital Jeanne de Flandre
Lille, , 59 000, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pregnancy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Nugent score >= 7

- pregnant women < 15 weeks (strictly)

- signed informed consent

- >=18 old

- speaking and understanding French language

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- metrorrhagias during 7 days before


- birth anticipated in an other area


- clindamycin allergy

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PregnancyPrevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
NCT00642980
  1. Lille,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
Official Title  ICMJE Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy
Brief Summary

Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester

Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.

Detailed Description

Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with such histories will be defined as at high risk.

Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.

High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Drug: Clindamycin
    300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
    Other Name: non applicable
  • Drug: Placebo
    Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
    Other Name: non applicable
  • Drug: Clindamycin
    300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart
    Other Name: non applicable
Study Arms  ICMJE
  • Active Comparator: Clindamycin Cure 1
    Arm 1
    Intervention: Drug: Clindamycin
  • Active Comparator: Clindamycin Cure 2
    Arm 2
    Intervention: Drug: Clindamycin
  • Placebo Comparator: Placebo
    Arm placebo
    Intervention: Drug: Placebo
Publications * Subtil D, Brabant G, Tilloy E, Devos P, Canis F, Fruchart A, Bissinger MC, Dugimont JC, Nolf C, Hacot C, Gautier S, Chantrel J, Jousse M, Desseauve D, Plennevaux JL, Delaeter C, Deghilage S, Personne A, Joyez E, Guinard E, Kipnis E, Faure K, Grandbastien B, Ancel PY, Goffinet F, Dessein R. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Nov 17;392(10160):2171-2179. doi: 10.1016/S0140-6736(18)31617-9. Epub 2018 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2013)
3105
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2008)
2700
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nugent score >= 7
  • pregnant women < 15 weeks (strictly)
  • signed informed consent
  • >=18 old
  • speaking and understanding French language

Exclusion Criteria:

  • metrorrhagias during 7 days before
  • birth anticipated in an other area
  • clindamycin allergy
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00642980
Other Study ID Numbers  ICMJE 060216
PHRC 2004/1918 ( Other Identifier: DHOS )
PHRC 2008/1929 ( Other Identifier: DHOS )
2004/0428 ( Other Identifier: sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Damien SUBTIL, MD PhDUniversity Hospital, Lille (France)
Study Chair:Gilles Brabant, MDGroupe Hospitalier de l' Institut Catholique, Lille
PRS Account University Hospital, Lille
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP