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Randomized Controlled Trial
. 2016 Mar;214(3):373.e1-373.e12.
doi: 10.1016/j.ajog.2015.10.012. Epub 2015 Oct 23.

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial

Daniel G Kiefer  1 , Jolene C Muscat  2 , Jarrett Santorelli  3 , Martin R Chavez  2 , Cande V Ananth  4 , John C Smulian  5 , Anthony M Vintzileos  2
Affiliations
Randomized Controlled Trial

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial

Daniel G Kiefer et al. Am J Obstet Gynecol. 2016 Mar.

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.

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.

Keywords: Seprafilm; adhesion barrier; adhesion formation; adhesions; cesarean; modified sodium hyaluronic acid carboxymethylcellulose.

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Conflict of interest statement

CONFLICT OF INTEREST: The authors report no conflict of interest.

Figures

Figure 1
Figure 1
CONSORT Patient flow diagram
Figure 2
Figure 2
Boxplot of the adhesion score at the time of subsequent cesarean delivery
See this image and copyright information in PMC

References

    1. Hamilton BEMJ, Ventura SJ. Births: Preliminary Data for 2011. Natl Vital Stat Rep. 2012 Oct 3;61(5):1–20. - PubMed
    1. Gregory KD, Fridman M, Korst L. Trends and patterns of vaginal birth after cesarean availability in the United States. Semin Perinatol. Aug;34(4):237–43. - PubMed
    1. Ananth CV, Smulian JC, Vintzileos AM. The association of placenta previa with history of cesarean delivery and abortion: a metaanalysis. American journal of obstetrics and gynecology. 1997 Nov;177(5):1071–8. - PubMed
    1. Getahun D, Oyelese Y, Salihu HM, Ananth CV. Previous cesarean delivery and risks of placenta previa and placental abruption. Obstetrics and gynecology. 2006 Apr;107(4):771–8. - PubMed
    1. Wood SL, Chen S, Ross S, Sauve R. The risk of unexplained antepartum stillbirth in second pregnancies following caesarean section in the first pregnancy. Bjog. 2008 May;115(6):726–31. - PubMed

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