Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis - Full Text View

Sponsors and Collaborators:	University Hospital, Lille Ministry of Health, France Pfizer
Information provided by:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT00642980

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
Pregnant Women	Drug: Clindamycin Drug: Placebo	Phase IV

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	2700
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Clindamycin 300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
2: Active Comparator	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
3: Placebo Comparator	Drug: Placebo Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart

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

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

Contacts

Contact: Damien SUBTIL, PHD	33 +3 20 44 66 26	d-subtil@chru-lille.fr
Contact: Gilles BRABANT, MD	33 +3 20 87 48 50	Brabant.Gilles@ghicl.net

Locations

France
Hopital Jeanne de Flandre	Recruiting
Lille, France, 59 000
Contact: Damien Subtil, PhD 33 +3 20 44 66 26 d-subtil@chru-lille.fr
Contact: Christine Leignel, CRA 33 +3 20 44 68 74 premeva@chru-lille.fr

Sponsors and Collaborators

University Hospital, Lille

Ministry of Health, France

Pfizer

Investigators

Principal Investigator:	Damien Subtil, PhD	University Hospital, Lille (France)
Study Chair:	Gilles Brabant, MD	Groupe Hospitalier de l' Institut Catholique, Lille

More Information

Website of the study (for patients and all kinds of public) This link exits the ClinicalTrials.gov site

Responsible Party:	Direction de la Recherche Clinique Nord Pas de Calais ( Ministry of Health (Programme Hospitalier de Recherche Clinique) )
Study ID Numbers:	University Hospital Lille (F), PHRC 2004 CP 04156, PHRC 2008(in progress n°1929)
Study First Received:	March 21, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00642980
Health Authority:	France: National Consultative Ethics Committee for Health and Life Sciences; France: Afssaps - French Health Products Safety Agency; France: Ministry of Health

Keywords provided by University Hospital, Lille:

Pregnancy
Preterm delivery
Bacterial vaginosis
Randomized Clinical Trial
Clindamycin

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Clindamycin
Pregnancy Complications
Vaginosis, Bacterial
Clindamycin-2-phosphate

Obstetric Labor, Premature
Vaginitis
Obstetric Labor Complications
Vaginal Diseases
Premature Birth

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009