RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section
Status:
Withdrawn
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum
infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS
infections is 7-10%. The most common infections are endometritis, Urinary tract infections
(UTI) and wound infections (WI).
Prophylactic antibiotics are effective in preventing postoperative infections and national
guidelines recommend that antibiotics should be administered as a single dose immediately
before surgical incision. CS is an exception to this pre-incision administration approach.
National guidelines recommend administration of antibiotics after umbilical cord clamping to
avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic
prophylaxis for CS suggest that prophylactic antibiotics administered before incision
compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two
Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on
the baby and on late infection in the mother.
This study is a double-blinded randomized controlled trial with a concurrent Health Economic
Assessment. The study will examine the effect of change in timing of prophylactic antibiotics
on the rate of post-CS infections (endometritis, UTI and WI). The study will be performed at
the obstetric departments at Odense University Hospital (OUH), Hvidovre Hospital (HH) and
Hospital South West Jutland (HSWJ) in collaboration with the Department of Clinical
Microbiology, OUH, to ensure that the most appropriate antibiotic regime is used.
Furthermore, collaboration with a neonatologist will ensure appropriate assessment of
neonatal outcome.
The investigators plan to enroll the first patient at OUH February 2013. HH and HSWJ will
follow with a couple of months delay. The inclusion period is scheduled to last until the
investigators have 2844 participants, who have answered the questionnaire. The investigators
expect to complete the inclusion period in October 2014 (last patient last visit, LPLV).
Microbiological analyzes and data processing is expected to be completed one year after the
LPLV. The study population is all women delivering a child by CS during the project period,
at Department of Gynaecology and Obstetrics of OUH, HH and HSWJ.
Objective: Investigate whether and by how much antibiotics administered 15-60 minutes before
incision versus after umbilical cord clamping reduces the rate of postpartum infections in a
Danish population of women undergoing CS.
Hypothesis: Antibiotics administered pre-incision will result in fewer postoperative
infections than antibiotics administered after the umbilical cord is cut.
Hypothesis: Antibiotics administered before incision are cost-effective, compared to
administration after umbilical cord clamping, measured by post-CS infection and as cost per
Quality Adjusted Life Year (QALY).
Phase:
Phase 4
Details
Lead Sponsor:
Odense University Hospital
Collaborators:
Hospital of South West Jutland Hvidovre University Hospital Region of Southern Denmark University of Southern Denmark