Natural Microbiota Restoration After C-section Birth

Study Overview
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Brief Summary
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The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery. The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.

Official Title
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Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne

Conditions
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Insufficient Intestinal Microbiota Diversity After C-section Birth

Intervention / Treatment
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* Other: perineal impregnated swab
* Other: clean swab


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>75 children born by planned C-section will be exposed to the perineal microbiota of their mothers through perineal impregnated swab. | Other: perineal impregnated swab<br>* After planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions.<br>|
| Placebo Comparator: Placebo Group<br>75 children born by planned C-section will be exposed to clean swab. | Other: clean swab<br>* After planned C-section birth, newborns will suck on clean swab.<br>|
| No Intervention: Control Group<br>75 children born vaginally. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diversity of the intestinal microbiota | Intestinal microbiota diversity will be evluated through metagenomics. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status | Health status of the newborn will be evaluated through questionnaries. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-section, Microbiota