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Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis (PREMEVA)
This study is currently recruiting participants.
Study NCT00642980   Information provided by University Hospital, Lille
First Received: March 21, 2008   Last Updated: March 24, 2008   History of Changes

March 21, 2008
March 24, 2008
April 2006
December 2010   (final data collection date for primary outcome measure)
Premature delivery (16 to 32 weeks of gestation) [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00642980 on ClinicalTrials.gov Archive Site
Preterm labor, PPROM, Spontaneous preterm labor, PROM, Abruptio placentae, Chorioamnionitis, Fever > 38°C during labor, Post partum fever (> 38°), Post-partum wound infections, Perinatal death, NICU transfer, Bacterial neonatal colonisation. [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
Same as current
 
Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy

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.

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.

Phase IV
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Pregnant Women
  • Drug: Clindamycin
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
2700
December 2011
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Damien SUBTIL, PHD 33 +3 20 44 66 26 d-subtil@chru-lille.fr
Contact: Gilles BRABANT, MD 33 +3 20 87 48 50 Brabant.Gilles@ghicl.net
France
 
NCT00642980
Ministry of Health (Programme Hospitalier de Recherche Clinique), Direction de la Recherche Clinique Nord Pas de Calais
University Hospital Lille (F), PHRC 2004 CP 04156, PHRC 2008(in progress n°1929)
University Hospital, Lille
  • Ministry of Health, France
  • Pfizer
Principal Investigator: Damien Subtil, PhD University Hospital, Lille (France)
Study Chair: Gilles Brabant, MD Groupe Hospitalier de l' Institut Catholique, Lille
University Hospital, Lille
January 2008

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