Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
NCT00642980
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- Nugent score >= 7
- pregnant women < 15 weeks (strictly)
- signed informed consent
- >=18 old
- speaking and understanding French language
- metrorrhagias during 7 days before
- birth anticipated in an other area
- clindamycin allergy
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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 3105 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |