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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT02567071 |
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Date of registration:
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15/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Natural Microbiota Restoration After C-section Birth
RESTORE |
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Scientific title:
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Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne |
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Date of first enrolment:
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April 6, 2016 |
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Target sample size:
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33 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02567071 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Jacky Nizard, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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APHP |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- over the age of legal majority
- delivery by planned C-section at term or vaginal delivery at term
- registered at a social security service
Exclusion Criteria:
- HIV or other STD patients
- immunocompromised patients
- known streptococcus B carriers
- known vaginal or perineal herpes infections
- chronic disease patients (obesity, diabetes, IBD)
- IMC before pregnancy > 30 kg/m²
- antibiotic treatments one month before delivery
- emergency C-section
- Premature delivery (<37 amenorrhea weeks)
- hospitalized for more than one week before delivery
- known HVC infections
- for the newborns: every diagnosed anomaly
- patients who do not understand the research procedures or those that are
institutionalized, or those unable to give informed consent
- patients deprived of ther liberty by legal or administrative decisions
- patients under an exclusion period from another study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Insufficient Intestinal Microbiota Diversity After C-section Birth
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Intervention(s)
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Other: clean swab
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Other: perineal impregnated swab
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Primary Outcome(s)
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Diversity of the intestinal microbiota
[Time Frame: 1 year]
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Secondary Outcome(s)
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Health status
[Time Frame: 1 year]
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Secondary ID(s)
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C14-70
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2015-A00586-43
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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