NCT00642980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,105

participants targeted

Target at P75+ for phase_4 pregnancy

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 1, 2025

Status Verified

January 1, 2008

Enrollment Period

5.2 years

First QC Date

March 21, 2008

Last Update Submit

September 25, 2025

Conditions

Pregnancy

Keywords

PregnancyPreterm deliveryBacterial vaginosisRandomized Clinical TrialClindamycin

Outcome Measures

Primary Outcomes (1)

  • Premature delivery (16 to 32 weeks of gestation)

    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.

    At delivery

Study Arms (3)

Clindamycin Cure 1

ACTIVE COMPARATOR

Arm 1

Drug: Clindamycin

Clindamycin Cure 2

ACTIVE COMPARATOR

Arm 2

Drug: Clindamycin

Placebo

PLACEBO COMPARATOR

Arm placebo

Drug: Placebo

Interventions

ClindamycinDRUG

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

Also known as: non applicable
Clindamycin Cure 1
PlaceboDRUG

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

Also known as: non applicable
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nugent score \>= 7
  • pregnant women \< 15 weeks (strictly)
  • signed informed consent
  • \>=18 old
  • speaking and understanding French language

You may not qualify if:

  • metrorrhagias during 7 days before
  • birth anticipated in an other area
  • clindamycin allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Jeanne de Flandre

Lille, 59 000, France

Location

Related Publications (1)

  • 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.

    PMID: 30322724BACKGROUND

Related Links

MeSH Terms

Conditions

Premature BirthVaginosis, Bacterial

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Damien SUBTIL, MD PhD

    University Hospital, Lille (France)

    PRINCIPAL INVESTIGATOR

  • Gilles Brabant, MD

    Groupe Hospitalier de l' Institut Catholique, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

April 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 1, 2025

Record last verified: 2008-01

Locations

FR(1)