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

University Hospital, Lille

Status and phase: Completed; Phase 4

Conditions: Pregnancy

Treatments: Drug: Clindamycin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00642980

PHRC 2008/1929 (Other Identifier)

2004/0428 (Other Identifier)

PHRC 2004/1918 (Other Identifier)

060216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,105 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,105 participants in 3 patient groups, including a placebo group

Clindamycin Cure 1

Active Comparator group

Description:

Arm 1

Treatment:

Drug: Clindamycin

Drug: Clindamycin

Clindamycin Cure 2

Active Comparator group

Description:

Arm 2

Treatment:

Drug: Clindamycin

Drug: Clindamycin

Placebo

Placebo Comparator group

Description:

Arm placebo

Treatment:

Drug: Placebo