Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822782
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.

A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.


Condition or disease Intervention/treatment
Vaginal Lesion Biological: Bacteriological analysis of vaginal sample

Layout table for study information
Study Type : Observational
Actual Enrollment : 1100 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
Cases
The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Cases" are classified as those with a vaginal lesion due to delivery.
Biological: Bacteriological analysis of vaginal sample
Bacteriological analysis of vaginal sample

Controls
The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months. "Controls" are classified as those without a vaginal lesion due to delivery.
Biological: Bacteriological analysis of vaginal sample
Bacteriological analysis of vaginal sample




Primary Outcome Measures :
  1. Presence/absence of a vaginal lesion due to delivery [ Time Frame: Upon delivery (Day 0) ]
  2. Record of abnormal vaginal flora (presence/absence of Nugent's score > 3) in patient's medical file [ Time Frame: Upon delivery (Day 0) ]
    Record of routine analysis of vaginal samples during pregnancy will be used.


Secondary Outcome Measures :
  1. Recorded qualitative and quantitative analysis of vaginal flora in patient's file [ Time Frame: Upon delivery (Day 0) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of all consecutive women meeting inclusion/exclusion criteria and delivering at the Nîmes University Hospital, France during an inclusion period of 6 months.
Criteria

Inclusion Criteria:

  • Pregnant women with a gestational age > 34 weeks delivering at the Nîmes University Hospital

Exclusion Criteria:

  • Patient under judicial protection
  • Adult patient under any kind of guardianship
  • Patient refuses participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822782


Locations
Layout table for location information
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Laurie Becerra, Sage Femme Centre Hospitalier Universitaire de Nîmes
Study Director: Jean-Philippe Lavigne, MD, PhD Centre Hospitalier Universitaire de Nîmes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01822782     History of Changes
Other Study ID Numbers: LOCAL/2013/LB-01
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Perineal tear
Perineal lesion
Vaginal flora
Birth