title: The impact of obstetric gel on the second stage of labor and perineal integrity: a randomized controlled trial.
abstract: OBJECTIVE
  Dianatal® is a bioadhesive gliding film which reduces the opposing force to vaginal childbirth. We aimed to investigate the safety, applicability, and impact of Dianatal® obstetric gel on second stage of labor and perineal integrity.
  
  
  METHODS
  Low-risk singleton pregnancies at term were prospectively enrolled. Eligible women were randomly assigned to either labor management without using obstetric gel, or labor management using intermittent application of obstetric gel into the birth canal during vaginal examinations, starting at active phase of labor (≥4 cm dilation). The primary measured outcome was the length of second stage of labor.
  
  
  RESULTS
  Overall, 200 cases were analyzed. Demographic, obstetrical, and labor characteristics were similar between the groups. Neither adverse events nor maternal or neonatal side effects were observed. The mean lengths of the active and second stages of labor were comparable between the obstetric gel-treated and the control groups (157 versus 219 min and 48 versus 56 min, respectively). None of the women had grade III/IV perineal tears. Maternal and neonatal outcomes were not negatively influenced by using obstetric gel. No difference was found after sub-group analysis for spontaneous vaginal delivery.
  
  
  CONCLUSIONS
  Dianatal® obstetric gel is safe in terms of maternal or neonatal use. Albeit a trend toward shorter labor stages using Dianatal® obstetric gel, no significant differences were noted among the groups. In order to further investigate the influence of the obstetric gel on labor stage interval, perineal integrity and maternal and neonatal outcomes, larger randomized clinical trials are needed to be carried out.
authors.affiliation: a Helen Schneider Hospital for Women, Rabin Medical Center , Petach Tikva , Israel and.|b Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel.
authors.forename: Eran
authors.initials: E
authors.lastname: Ashwal
authors.affiliation: a Helen Schneider Hospital for Women, Rabin Medical Center , Petach Tikva , Israel and.|b Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Aviram
authors.affiliation: a Helen Schneider Hospital for Women, Rabin Medical Center , Petach Tikva , Israel and.|b Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel.
authors.forename: Avital
authors.initials: A
authors.lastname: Wertheimer
authors.affiliation: a Helen Schneider Hospital for Women, Rabin Medical Center , Petach Tikva , Israel and.|b Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel.
authors.forename: Eyal
authors.initials: E
authors.lastname: Krispin
authors.affiliation: a Helen Schneider Hospital for Women, Rabin Medical Center , Petach Tikva , Israel and.|b Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel.
authors.forename: Boris
authors.initials: B
authors.lastname: Kaplan
authors.affiliation: a Helen Schneider Hospital for Women, Rabin Medical Center , Petach Tikva , Israel and.|b Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel.
authors.forename: Liran
authors.initials: L
authors.lastname: Hiersch
mesh_terms: D000328:Adult; D016009:Chi-Square Distribution; D036861:Delivery, Obstetric / Q000379:methods; D004841:Episiotomy / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007748:Labor Stage, Second / Q000187:drug effects*; D054327:Lubricants / Q000008:administration & dosage*; D010502:Perineum / Q000293:injuries; D011247:Pregnancy; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage
chemical_list: D054327:Lubricants; D014622:Vaginal Creams, Foams, and Jellies
keywords: Obstetric gel; perineal integrity; perineal laceration; second stage of labor