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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47498

Enrollment

100

Registered

2018-02-05

Start date

2019-03-22

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiome disturbance in the mcirobiota of the gut Gut microbiome dysbiosis

Interventions

This study is a Phase 4 study with the intervention in this study being the timing of umbilical cord clamping. It is either done 1) After giving the mother the prophylactic antibiotic 2) Prior to gi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The composition and functionality of neonatal gut microbiome of the neonate is the main endpoint of the project. The following compositional outcomes will be used: - Alpha diversity (Shannon Diversity Index) - Beta diversity (Bray-Curtis dissimilarity) The following functional outcome will be used: - Metacyclin Pathways	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)