Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
Information source: University Hospital, Lille
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnant Women
Intervention: Clindamycin (Drug); Placebo (Drug); Clindamycin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Lille Official(s) and/or principal investigator(s):
Damien Subtil, PhD, Principal Investigator, Affiliation: University Hospital, Lille (France)
Gilles Brabant, MD, Study Chair, Affiliation: Groupe Hospitalier de l' Institut Catholique, Lille
Overall contact:
Damien SUBTIL, PHD, Phone: 33 +3 20 44 66 26, Email: d-subtil@chru-lille.fr
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.
Clinical Details
Official title: Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Premature delivery (16 to 32 weeks of gestation)
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Damien SUBTIL, PHD, Phone: 33 +3 20 44 66 26, Email: d-subtil@chru-lille.fr
Hopital Jeanne de Flandre, Lille 59 000, France; Recruiting
Damien Subtil, PhD, Phone: 33 +3 20 44 66 26, Email: d-subtil@chru-lille.fr
Christine Leignel, CRA, Phone: 33 +3 20 44 68 74, Email: premeva@chru-lille.fr
Additional Information
Website of the study (for patients and all kinds of public)
Starting date: April 2006
Ending date: December 2011
Last updated: March 24, 2008
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