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

CompletedPhase 4

Sponsor: University Hospital, Lille

Conditions: Pregnancy

Interventions: Clindamycin, Placebo, Clindamycin

Countries: France

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (1)

Lille, France