MAMA

Methods

This multicenter, two-arm, non-interventional, observational study analyzes the qualitative and quantitative changes in the gut microbiome of mothers at birth due to antibiotic prophylaxis with cefuroxime. We recruited pregnant women from two perinatal centers in Germany, from outpatient facilities and via social media channels. Women with C-section were recruited for the study group, women with vaginal birth and without use of antibiotics as control. Participants gave their informed consent to participate in the study after a detailed consultation with the study coordinator. Each women submitted three stool samples (T0, T1, T2) for microbiome analysis. Stool samples were collected by the participant following a detailed description and using “DNA/RNA ShieldTM Fecal Collection Tube – DX” by Zymo Research to prevent quality loss during postal transport. Collection took place at home or (in case of prolonged inpatient treatment after delivery) at the hospital. Required metadata was collected via questionnaires. Stool samples and questionnaires were then sent back to the study coordinator. Thus, no additional on-site visits were required.

The taxonomic identification and quantification of the microbiome is performed by sequencing the 16S rRNA gene (V3/V4). The biostatistical analysis includes taxonomic annotation, OTU clustering and determination of α- and β-diversity. The changes in the microbiome (diversity, frequency, variance) of the study groups will show whether and which permanent (> 3 months) changes in the intestinal microbiome are caused by PAP with cefuroxime in mothers at birth. In particular, the (new) occurrence of potentially pathogenic species (induced dysbiosis) and changes in the physiological flora will be investigated, as women towards the end of pregnancy have an especially vulnerable microbiome. Permanent dysbiosis can be a risk factor for gestational diabetes in subsequent pregnancies.