Transfer of Strictly Anaerobe Microbes From Mother to Child

NCT04140747 | Completed

• 1 other identifier: 28-524 ex 15/16
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the changes in the microbiota at different body sites in late pregnancy, in comparison with non-pregnant women, with particular emphasis on archaea, and to identify possible maternal-to-child transfer routes for acquisition of strictly anaerobic microorganisms by analyzing the gut microbiota of new born infants (delivered vaginally or by C-section).

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (2)

• maternal microbiome

  difference between non-pregnant and pregnant women

  2020-2023

• fetal/neonatal microbiome

  difference between vaginal and C-section born infants

  2020-2023

Secondary Outcomes (1)

• Human milk oligosaccharides

  2020-2023

Study Arms (3)

non-pregnant women

Samples will be collected from 30 healthy, non-pregnant women in the reproductive age: blood, urine, stool, saliva, oral swabs, vaginal swabs

pregnant women delivering vaginally

From 30 healthy, pregnant women giving vaginal birth, samples will be collected shortly before, during and after birth from maternal and newborn sites: maternal blood, urine, stool, saliva, oral swabs, vaginal swabs; cord blood, colostrum, meconium, infant oral swabs

pregnant women undergoing C-section

From 30 healthy, pregnant women giving vaginal birth, samples will be collected shortly before, during and after birth from maternal and newborn sites: maternal blood, urine, stool, saliva, oral swabs, vaginal swabs; amniotic fluid, cord blood, colostrum, meconium, infant oral swabs

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy non-pregnant women and women with an ongoing healthy pregnancy. 3 groups will be formed: non-pregnant women (n=30), women delivering vaginally (n=30) and women undergoing C-section (n=30).

You may qualify if:

• healthy women
• pregnant women: delivery at term (gestational age 37-42); contractions or rupture of membrane no longer than 12h before admission to hospital

You may not qualify if:

• bacterial/ fungal infections
• use of antibiotics/ probiotics in past 3 months
• fetal anomalies
• multiple pregnancies
• diabetes type 1, 2, gestational diabetes
• hypertension, preeclampsia/HELLP
• HIV ( human immunodeficiency virus), HCV (Hepatitis C)
• drug abuse, smoking

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8043, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

from non-pregnant and pregnant women: serum, urine, oral swabs, vaginal swabs, stool from pregnant women undergoing C-section: amniotic fluid from newborn babies: cord blood, oral swabs, meconium, stool sample of day 1-3 colostrum and breast milk samples

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evelyn Jantscher-Krenn, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Christine Moissl-Eichinger, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: October 7, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

AU (1)