Surgical Wound Infection Clinical Trial
Official title:
Antibiotic Prophylaxis for Postpartum Infections Following Caesarean Section
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.
At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and
simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation
of the digestive and immune functions to avoid gut disorders and infections. Full-term,
breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene
levels, antibiotics treatment and formula feeding may inhibit immune development both short
and long term. Birth by caesarean section in high-hygiene hospital environments, and
widespread use of antibiotics, are factors that reduce gut microbiota density and diversity
in the newborn for some time after birth. On the other hand, high-hygiene environments and
antibiotics are essential tools to combat infections, especially for the weakest newborn
infants.
This pilot study will be a feasibility study to the original study, which examines the
effect of change in timing of prophylactic antibiotics on the rate of post-CS infections
(endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut
microbiota of newborn infants. The feasibility study will only include pregnant women in
Odense with a body mass index below 30, and planned cesarean section.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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