Background
The rising cesarean birth rate has drawn attention to risks associated with
repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted
as a way to decrease operative difficulty. However, robust data demonstrating
effectiveness of such interventions are lacking.
Objective
We report data from a multicenter trial designed to evaluate the short-term
safety and effectiveness of a modified sodium hyaluronate-carboxymethylcellulose
absorbable (HACMC) for reduction of adhesions following cesarean delivery.
Methods
Patients that underwent primary or repeat cesarean delivery were included in
this multicenter, single-blinded (patient), randomized controlled trial. Patients were
randomized into either HA-CMC (N=380) or no-treatment group (N=373). No
other modifications to their treatment were part of the protocol. Short-term safety data
was collected following randomization. The location and density of adhesions (primary
outcome) were assessed at their subsequent delivery using a validated tool, which can
also be used to derive an adhesion score, that ranges from 0–12.
Results
No differences in baseline characteristics, post-operative course, or incidence
of complications between the groups following randomization were noted. Eighty patients
from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in
any location were reported in 75.6% of the HA-CMC group and 75.9% of the
controls (P=0.99). There was no significant difference in the median adhesion
score; 2 (range 0–10) for the HACMC group vs. 2 (range 0–8) for the
control group (P=0.65). One third of the HA-CMC patients met the definition for
severe adhesions (adhesion score >4) compared to 15.5% in the control group
(P=0.052). There were no significant differences in the time from incision to
delivery (P=0.56). Uterine dehiscence in the next pregnancy was reported in 2
patients in HA-CMC group versus 1 in the control (P=0.60).
Conclusions
Although we did not identify any short-term safety concerns, HA-CMC adhesion
barrier applied at cesarean delivery did not reduce adhesion formation at the subsequent
cesarean delivery.