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NCT Number: NCT00642980

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

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.

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Key information

Conditions

Pregnancy Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Jeanne de Flandre

Lille, 59 000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clindamycin

Drug

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

Other names: non applicable

Placebo

Drug

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

Other names: non applicable

Primary outcomes

  1. Premature delivery (16 to 32 weeks of gestation)

    Time frame: At delivery

Secondary outcomes

  1. 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.

    Time frame: At delivery

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Pfizer

Registry information

Official study title

Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy

Acronym: PREMEVA

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2008
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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