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

Pregnancy Clinical Trial

— PREMEVA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642980
• Other study ID #: 060216
• Secondary ID: PHRC 2004/1918PH
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2008
• Last updated: January 22, 2014
• Start date: April 2006
• Est. completion date: June 2011

Study information

• Verified date: January 2008
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3105
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pregnancy
• Premature Birth
• Vaginosis, Bacterial

Intervention

Drug:
• Clindamycin
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
• Placebo
Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
• 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

Locations

Country	Name	City	State
France	Hopital Jeanne de Flandre	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature delivery (16 to 32 weeks of gestation)		At delivery	Yes
Secondary	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.		At delivery	Yes