JMIR Publications

ABSTRACT

Background:

Cesarean section (CS) rates are rising globally and now exceed 20 %. Perioperative antibiotic prophylaxis (PAP) using cephalosporins, like cefuroxime, is standard to prevent surgical site infections. While the impact of PAP on neonatal microbiota is well studied, its effects on the maternal gut microbiome remain largely unexplored. The “Microbiome changes due to Antibiotic prophylaxis in Mothers At birth” (MAMA) study aims to close this knowledge gap.

Objective:

To assess qualitative and quantitative changes in the maternal gut microbiome associated with single-shot PAP using cefuroxime during CS. This paper presents the protocol, rationale, and implementation of a fully remote study approach.

Methods:

MAMA is a prospective, two-arm, observational cohort study originally planned to include 25 participants per group (CS with PAP vs vaginal birth without antibiotics). All sampling and documentation were conducted by participants at home. Following informed consent, participants self-collected fecal samples at three time points: before delivery (T0), 2–3 days postpartum (T1), and 90 (±10) days postpartum (T2). Sampling occurred at home, supported by pre-labeled mail-in kits. Microbiome profiling is based on 16S rRNA gene sequencing, with analysis of alpha- and beta-diversity and abundance shifts. Metadata were collected via questionnaires. No in-person visits were required.

Results:

A total of 31 participants were enrolled (21 CS, 10 control). Recruitment has been completed. In addition to stool samples, metadata were collected via structured questionnaires at three time points, covering maternal health, medication use (including postpartum antibiotics), and lifestyle. Microbiome changes will be analyzed in relation to these metadata. We expect a PAP-induced reduction in alpha-diversity and beneficial taxa (e.g., Bifidobacteria) in the CS group at T1, with potential overgrowth of Enterobacteriaceae or Clostridioides difficile. T2 sampling will assess recolonization or persistent dysbiosis.

Conclusions:

This protocol presents a novel, decentralized model for studying microbiome dynamics in pregnancy. It minimizes participant burden while maintaining scientific rigor and enabling inclusion across geographic and logistical boundaries. MAMA exemplifies how interdisciplinary, digital study designs can advance maternal health research. Clinical Trial: German Clinical Trials Register (Deutsches Register Klinischer Studien: DRKS00027305); WHO ICTRP (DRKS00027305) Ethics Approval: Ethics Committee of Witten/Herdecke University, vote 274/2021