C-section clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT04134819 Recruiting - C Section Clinical Trials

Missing Microbes in Infants Born by Cesarean Section

MiMIC

Start date: July 1, 2019
Phase:
Study type: Observational

General adult healthy pregnant females in total 400, as well as their infants will be recruited. It is expected 67% will be vaginally delivered and 33% will be C Section deliveries. It is expected that of these groups that 40% of these women will be treated with antibiotics during their pregnancy. All C Section women (including emergency C Section) will be treated with IV Cefazolin at the time of incision, in theatre, to prevent internal wound infection. Primary objective The effect of maternal antibiotic administration during pregnancy upon the development of the intestinal microbiota until the age of two years; of C-section delivered infants compared to C-section delivered infants born to non-antibiotic treated pregnant women. To develop a cohort of vaginally delivered infants to isolate the 'missing microbes' (intestinal) in the groups above. Secondary objective The effect of maternal antibiotics on the developing infant by: - Anthropometric assessment: Body weight and Body length - Bayley scale of infant development test at age 2 years Ancillary - To isolate and characterise bacterial strains from fresh healthy infant faeces that are altered in the stools from C-section delivered and antibiotic treated infants and compared to vaginally delivered infants. - The effect of maternal antibiotic treatment on the human milk microbiome during lactation - Stress hormone levels of mothers and infants - Mental health questionnaire of mothers - Food frequency questionnaire of mothers Exploratory - To identify bacterial strains that can be further developed into probiotic products to help replenish depleted microbiota in the infant gut, born by C Section and or treated with antibiotics