Natural Microbiota Restoration After C-section Birth

NCT ID: NCT02567071

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-06
• Study Completion Date: 2019-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

75 children born by planned C-section will be exposed to the perineal microbiota of their mothers through perineal impregnated swab.

Group Type: EXPERIMENTAL

perineal impregnated swab

Intervention Type: OTHER

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

Placebo Group

75 children born by planned C-section will be exposed to clean swab.

Group Type: PLACEBO_COMPARATOR

clean swab

Intervention Type: OTHER

After planned C-section birth, newborns will suck on clean swab.

Control Group

75 children born vaginally.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

perineal impregnated swab

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

Intervention Type: OTHER

clean swab

After planned C-section birth, newborns will suck on clean swab.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacky Nizard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Service de Gynécologie-Obstétrique, Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

2015-A00586-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

C14-70

Identifier Type: -

Identifier Source: org_study_id