Clinical Trial: A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary:

In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was 21 % and 16% to 38% in case of dystocia.

The definition of " dystocia " is traditionally based on the research led by Friedman in the 1950's on a restricted population sample. Several studies over the last years seem to indicate that the different phases of labour are longer than originally described by Friedman.

Our current hypothesis is that the application of a new definition of dystocia would enable a more appropriate management of labour.

Detailed Summary:

The main purpose of this study is to show a significant decrease of the CS rate with the use of the new partograph developed by Neal and Lowe.

Secondary purposes are

• To reduce the use of oxytocin during labour without increasing maternal or neonatal morbidity;
• To decrease immediate per-operative complications and post-operative complications associated with CS

Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Cesarean section rate (all causes) [ Time Frame: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Total amount of oxytocin used (mUI)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of uterine hyperstimulation (%)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of post-partum hemorrhage (%)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of uterine rupture (%)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of retained placenta (%)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Need of an artificial rupture of membranes (Y/N)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Color of the amniotic fluid
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Duration of the first and second stages of labour
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of vaginal delivery (spontaneous or assisted) (%)
• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of cesarean section (according to indication) (%)
• Maternal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Need for an epidural or general anaesthesia
• Maternal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Transfusion rate (%)
• Maternal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Maternal fever during labour (°C)
• Maternal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of thrombo-embolic events (%)
• Maternal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of third- and fourth-degree perineal tears and episiotomy (%)
• Maternal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Rate of surgical site infection, endometritis or septicemia (%)
• Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome [ Time Frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days) ]
  Neonatal arterial umbilical cord pH < 7,0
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University Hospital, Strasbourg, France
  

  Dates:
  Date Received: January 12, 2016
  Date Started: September 2016
  Date Completion:
  Last Updated: September 16, 2016
  Last Verified: September 2016
  

  

  Join Millions

  Sign Up For One Of Our
  Newsletters

  Email

  Sign Up