Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
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.

PubMed Disclaimer

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

Publication types

LinkOut - more resources