title: Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.
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 adhesion barrier for reduction of adhesions following cesarean delivery.
  
  
  METHODS
  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).
  
  
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Lehigh Valley Health Network, Allentown, PA; Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY; Department of Obstetrics, Gynecology, and Reproductive Medicine, Stony Brook University, Stony Brook, NY. Electronic address: Daniel_g.kiefer@lvhn.org.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Kiefer
authors.affiliation: Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY.
authors.forename: Jolene C
authors.initials: JC
authors.lastname: Muscat
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Medicine, Stony Brook University, Stony Brook, NY; Department of Surgery, University of Buffalo, Buffalo, NY.
authors.forename: Jarrett
authors.initials: J
authors.lastname: Santorelli
authors.affiliation: Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Chavez
authors.affiliation: Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY.
authors.forename: Cande V
authors.initials: CV
authors.lastname: Ananth
authors.affiliation: Department of Obstetrics and Gynecology, Lehigh Valley Health Network, Allentown, PA.
authors.forename: John C
authors.initials: JC
authors.lastname: Smulian
authors.affiliation: Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY.
authors.forename: Anthony M
authors.initials: AM
authors.lastname: Vintzileos
mesh_terms: D000328:Adult; D002266:Carboxymethylcellulose Sodium / Q000009:adverse effects / Q000627:therapeutic use*; D002585:Cesarean Section / Q000009:adverse effects* / Q000379:methods; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D016037:Single-Blind Method; D013997:Time Factors; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control*
chemical_list: D004338:Drug Combinations; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium
keywords: Seprafilm; adhesion barrier; adhesion formation; adhesions; cesarean; modified sodium hyaluronic acid carboxymethylcellulose