Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis (PREMEVA)
Primary Purpose
Pregnancy
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Clindamycin
Placebo
Clindamycin
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Preterm delivery, Bacterial vaginosis, Randomized Clinical Trial, Clindamycin
Eligibility 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
Sites / Locations
- Hopital Jeanne de Flandre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Clindamycin Cure 1
Clindamycin Cure 2
Placebo
Arm Description
Arm 1
Arm 2
Arm placebo
Outcomes
Primary Outcome Measures
Premature delivery (16 to 32 weeks of gestation)
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.
Full Information
NCT ID
NCT00642980
First Posted
March 21, 2008
Last Updated
January 22, 2014
Sponsor
University Hospital, Lille
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00642980
Brief Title
Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Pregnancy, Preterm delivery, Bacterial vaginosis, Randomized Clinical Trial, Clindamycin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clindamycin Cure 1
Arm Type
Active Comparator
Arm Description
Arm 1
Arm Title
Clindamycin Cure 2
Arm Type
Active Comparator
Arm Description
Arm 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm placebo
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Other Intervention Name(s)
non applicable
Intervention Description
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
non applicable
Intervention Description
Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Other Intervention Name(s)
non applicable
Intervention Description
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
Primary Outcome Measure Information:
Title
Premature delivery (16 to 32 weeks of gestation)
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien SUBTIL, MD PhD
Organizational Affiliation
University Hospital, Lille (France)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilles Brabant, MD
Organizational Affiliation
Groupe Hospitalier de l' Institut Catholique, Lille
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59 000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30322724
Citation
Subtil D, Brabant G, Tilloy E, Devos P, Canis F, Fruchart A, Bissinger MC, Dugimont JC, Nolf C, Hacot C, Gautier S, Chantrel J, Jousse M, Desseauve D, Plennevaux JL, Delaeter C, Deghilage S, Personne A, Joyez E, Guinard E, Kipnis E, Faure K, Grandbastien B, Ancel PY, Goffinet F, Dessein R. Early clindamycin for bacterial vaginosis in pregnancy (PREMEVA): a multicentre, double-blind, randomised controlled trial. Lancet. 2018 Nov 17;392(10160):2171-2179. doi: 10.1016/S0140-6736(18)31617-9. Epub 2018 Oct 12.
Results Reference
derived
Links:
URL
http://www.premeva.com
Description
Website of the study (for patients and all kinds of public)
Learn more about this trial
Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis
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