Microbiome examination after cesarean section or vaginal delivery, respectively
Conditions
Interventions
Group 1: Patients of the gynecological clinic in Cologne Holweide and the obstetrics department of St. Marien Hospital with elective cesarean delivery receive 1.5 g cefuroxime intravenously once 30 mi
t1: 2 - 3 days postpartum
t2: 90 +/- 10 days postpartum). From these samples, the microbiome is analyzed by NGS / PCR using 16s-rRNA. In the course of a screening visit and for each sample collection, patients fill out a quest
t2: 90 +/- 10 days postpartum). From these samples, the microbiome is analyzed by NGS / PCR using 16s-rRNA. As part of a pre-screening visit and for each sample collection, patients complete a subject
Sponsors
Kliniken der Stadt Köln gGmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Willingness to participate in the study (informed consent); Planned caesarean section in the next 4 weeks (group I); Expected vaginal delivery in the next 8 weeks (group II = control); Age = 18 years
Exclusion criteria
Exclusion criteria: Participation in another study; Use of immunosuppressants, antivirals, cytostatics, proton pump inhibitors (PPIs); Systemic use of other antibiotics, antifungals, fungicides during the past 3 months; Foreseeable need for antibiotics other than cefuroxime or planned surgery in the next 90 days; Chronic viral disease (HIV, HBV, HCV); Chronic intestinal disease (such as Crohn's disease or ulcerative colitis); Underlying hematologic or oncologic diseases; chronic kidney or liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of subjects with a change in biodiversity (alpha-diversity) from T0 to T1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects in which the microbiome at T2 has returned to T0 after a change at T1; Difference in biodiversity (beta-diversity) T0 to T1; Difference in biodiversity (beta-diversity) T1 to T2; Difference in biodiversity (beta-diversity) T0 to T2; Type and number of reduced bacterial orders; Number of subjects in which potential pathogens such as Clostridioides difficile are newly observed; Number of subjects in which potentially health-promoting bacteria such as Bifidobacteria increase; Increase in resistance genes (PCR) | — |
Countries
Germany
Contacts
Public ContactElisabeth Feles
Kliniken der Stadt Köln gGmbH
Outcome results
None listed