Clinical trial NCT00642980: Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Keywords: Pregnancy
Preterm delivery
Bacterial vaginosis
Randomized Clinical Trial
Clindamycin
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-03-25
Enrollment: 3105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Premature delivery (16 to 32 weeks of gestation)
timeFrame: At delivery
Secondary outcomes:
measure: 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.
timeFrame: At delivery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Jeanne de Flandre
Study officials:
affiliation: University Hospital, Lille (France)
name: Damien SUBTIL, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier de l' Institut Catholique, Lille
name: Gilles Brabant, MD
role: STUDY_CHAIR
References:
citation: 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.