NCT02567071

Natural Microbiota Restoration After C-section Birth

Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insufficient Intestinal Microbiota Diversity After C-section Birth

Interventions

Type	Name	Description
OTHER	perineal impregnated swab	After planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions.
OTHER	clean swab	After planned C-section birth, newborns will suck on clean swab.

Timeline

• Start date: 2016-04-06
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2015-10-02
• Last updated: 2021-08-26

Locations

1 site across 1 country: France