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Article
Effectiveness and Short-Term Safety of Modified Sodium Hyaluronic Acid-Carboxymethylcellulose at Cesarean Delivery: A Randomized Trial.
American Journal Of Obstetrics and Gynecology
  • Daniel G Kiefer, MD, Lehigh Valley Health Network
  • Jolene C Muscat, MD
  • Jarrett Santorelli, BS
  • Martin R Chavez, MD
  • Cande V Ananth, PhD, MPH
  • John C Smulian, MD, MPH, Lehigh Valley Health Network
  • Anthony M Vintzileos, MD
Publication/Presentation Date
3-1-2016
Abstract

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 hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable for reduction of adhesions following cesarean delivery.

STUDY DESIGN: Patients who 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 (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were 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, postoperative 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 = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .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 = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60).

CONCLUSION: 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.

PubMedID
26478104
Document Type
Article
Citation Information

Kiefer, D. G., Muscat, J. C., Santorelli, J., Chavez, M. R., Ananth, C. V., Smulian, J. C., & Vintzileos, A. M. (2016). Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial. American Journal Of Obstetrics And Gynecology, 214(3), 373.e1-373.e12. doi:10.1016/j.ajog.2015.10.012.