Timing of umbilical cord clamping during an elective caesarean delivery and its association with neonatal gut microbiome

Phase 4

Completed

Conditions: Microbiome
disturbance in the mcirobiota of the gut
Gut microbiome dysbiosis
10003816
10029903

Registration Number: NL-OMON47498

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Healthy pregnant women at >38 weeks of pregnancy undergoing elective cesarean section (CS) at the UMCG

Exclusion Criteria

Emergency cesarean section
Temperature >37.5 degrees celcius
Premature rupture of membranes
Cephalosporin allergy
Exposure to antibiotic agent 2 weeks before CS

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The composition and functionality of neonatal gut microbiome of the neonate is<br /><br>the main endpoint of the project.<br /><br><br /><br>The following compositional outcomes will be used:<br /><br><br /><br>- Alpha diversity (Shannon Diversity Index)<br /><br>- Beta diversity (Bray-Curtis dissimilarity)<br /><br><br /><br>The following functional outcome will be used:<br /><br><br /><br>- Metacyclin Pathways</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes for the study are: maternal endometritis and wound<br /><br>infection. Maternal endometritis will be diagnosed when maternal temperature is<br /><br>above 38ºC on two separate occasions, accompanied by uterine tenderness,<br /><br>tachycardia or leucocytosis. Wound infection is defined as purulent discharge,<br /><br>erythema and induration of surgical incision site.</p><br>