Impact of maternal antibiotics on infants born by C-section
Missing Microbes in Infants Born by Caesarean Section: Antenatal Antibiotics and Mode of Delivery
This study is trying to see how antibiotics given to pregnant women affect the gut bacteria of babies born by C-section compared to those born vaginally.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 22 Years to 40 Years |
| Sex | All |
| Sponsor | University College Cork Academic / other |
| Locations | 1 site (Cork, Munster) |
| Trial ID | NCT04134819 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how maternal antibiotic administration during pregnancy affects the intestinal microbiota development in infants born via cesarean section compared to those born vaginally. It will recruit 400 healthy pregnant women, with a focus on the differences in microbial composition between infants born to mothers treated with antibiotics and those who are not. The study will also assess the anthropometric measurements of the infants to evaluate their growth and health outcomes. By isolating the 'missing microbes' in these groups, the research seeks to understand the implications of delivery method and antibiotic exposure on infant health.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women aged 22 to 40 years with singleton pregnancies intending to exclusively breastfeed.
Not a fit: Patients with sick infants admitted to the neonatal unit or those with infants born prematurely (less than 35 weeks gestation) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing infant health and development by understanding the role of maternal antibiotics and delivery methods on gut microbiota.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated the importance of maternal microbiota in infant health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant females of age 22 to 40 years * Singleton pregnancy * Infants born within the Cork University Maternity Hospital * Women who are intending to exclusively breast feed their infant for a minimum of 6 weeks * Mothers who give birth to full term infants greater than 35 weeks' gestation * Infants who are born healthy with no underlying illness, syndrome or chronic disease * Participants who agree to maintain their usual dietary habits throughout the trial period * Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects * Consent to participate in the study and willing to comply with the protocol and study restrictions. Exclusion Criteria: * Sick infants who are admitted to the neonatal unit * Stillbirth or live birth where the baby is born alive but dies shortly after. * Infants born less than 35 (34 weeks +6 days) weeks gestation * Infants who are formula fed exclusively before 6 weeks of age * Mothers with insulin dependent gestational diabetes) * Mothers and infants who will live more than 45 minutes (driving) from hospital on discharge. * Self-declare history of alcohol abuse (for females: \>3 drinks on any single day and \>7 drinks per week * Self-declare use of illicit drugs * Participants under administrative or legal supervision. * Participation in another study with any investigational product within 60 days of screening
Where this trial is running
Cork, Munster
- Cork University Maternity Hospital, APC Microbiome Ireland, University College Cork, and Teagasc Food Research Centre, Moorepark, Fermoy, Co. Cork. IRELAND — Cork, Munster, Ireland (Recruiting)
Study contacts
- Principal investigator: Eugenen M Dempsey, PhD MD — APC Microbiome Ireland, University College Cork, Ireland.
- Study coordinator: Eugene M Dempsey, PhD MD
- Email: G.Dempsey@ucc.ie
- Phone: + 353 21 492 0524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.