Trial | NCT00642980  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    clindamycin ...

  • Study Participants

    3105
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.
Study Started
Apr 30
2006
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Jan 23
2014
Estimate

Drug Clindamycin

300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart

  • Other names: non applicable

Drug Placebo

Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart

  • Other names: non applicable

Drug Clindamycin

300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart

  • Other names: non applicable

Clindamycin Cure 1 Active Comparator

Arm 1

Clindamycin Cure 2 Active Comparator

Arm 2

Placebo Placebo Comparator

Arm placebo

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
No Results Posted