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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00642980
First received: March 21, 2008
Last updated: January 22, 2014
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Pregnancy
Drug: Clindamycin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Premature delivery (16 to 32 weeks of gestation) [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 3105
Study Start Date: April 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clindamycin Cure 1
Arm 1
Drug: Clindamycin
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Other Name: non applicable
Active Comparator: Clindamycin Cure 2
Arm 2
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 Name: non applicable
Placebo Comparator: Placebo
Arm placebo
Drug: Placebo
Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Other Name: non applicable

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642980

Locations
France
Hopital Jeanne de Flandre
Lille, France, 59 000
Sponsors and Collaborators
University Hospital, Lille
Pfizer
Investigators
Principal Investigator: Damien SUBTIL, MD PhD University Hospital, Lille (France)
Study Chair: Gilles Brabant, MD Groupe Hospitalier de l' Institut Catholique, Lille
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00642980     History of Changes
Other Study ID Numbers: 060216, PHRC 2004/1918, PHRC 2008/1929, 2004/0428
Study First Received: March 21, 2008
Last Updated: January 22, 2014
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health

Keywords provided by University Hospital, Lille:
Pregnancy
Preterm delivery
Bacterial vaginosis
Randomized Clinical Trial
Clindamycin

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Anti-Bacterial Agents
Premature Birth
Genital Diseases, Female
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Vaginal Diseases
Vaginitis
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014