Natural Microbiota Restoration After C-section Birth

Insufficient Intestinal Microbiota Diversity After C-section Birth Clinical Trial

— RESTORE  

Official title:

Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567071
• Other study ID #: C14-70
• Secondary ID: 2015-A00586-43
• Status: Completed
• Phase: N/A
• Start date: April 6, 2016
• Est. completion date: April 2019

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insufficient Intestinal Microbiota Diversity After C-section Birth

Intervention

Other:
• perineal impregnated swab
After planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions.
• clean swab
After planned C-section birth, newborns will suck on clean swab.

Locations

Country	Name	City	State
France	Service de Gynécologie-Obstétrique, Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diversity of the intestinal microbiota	Intestinal microbiota diversity will be evluated through metagenomics.	1 year
Secondary	Health status	Health status of the newborn will be evaluated through questionnaries.	1 year