Clinical Trial: Rebozo and External Cephalic Version in Breech Presentation.

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

Official Title: Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)

Brief Summary:

Breech presentation occurs in approximately 3-5% of all pregnancies, and breech birth is more complicated and risky for the fetus than births of fetuses in the cephalic position.

Therefore, it is desirable to turn the fetus from breech presentation to cephalic position before labour. This is traditionally done by external cephalic version, where the doctor manually tries to turn the fetus; the success rate of this is approximately 50%, and complications occur in about 0.5%. In addition there is discomfort and pain to the pregnant woman.

The investigators will assess the effect of using the rebozo prior to the external version. Use of rebozo is a recognized technique from Mexico, where the midwife with a scarf 'shake' the pregnant woman's pelvis over several sessions, so the fetus spontaneously turns to cephalic presentation or the external version is facilitated.

There are no known complications associated with the rebozo method. Use of rebozo in breech presentation has never before been studied scientifically, but is used in many places in the world. The investigators are planning an open-labeled randomized controlled study in pregnancies with verified breech or transverse presentation: by lot either standard external cephalic version or preceding rebozo-treatment with subsequent external cephalic version.

The investigators want to assess whether the use of rebozo - either as pre-treatment for external cephalic version or as a catalyst of spontaneous version - will increase the incidence of the cephalic presentations at labour and thus reduce the number of planned caesarean section.

The population will be pregnant women with ultrasound verified breech or transverse presentat

Detailed Summary:
Sponsor: Hvidovre University Hospital

Current Primary Outcome: Cephalic presentation [ Time Frame: After external cephalic version ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Version rate by the intervention only [ Time Frame: Before external cephalic version ]
  • Version rate by the standard external cephalic version [ Time Frame: At the external cephalic version ]
  • Rate of cesarean section by intervention and presentation. [ Time Frame: In labour ]
  • Dystocia in labor in cephalic presentation after version [ Time Frame: In labour ]
    Use of Pitocin, vacuum extraction and time frame.
  • Inducement of labour [ Time Frame: Before labour ]
  • Time frames for rupture of membranes, labour, first and second stage labour [ Time Frame: In Labour ]
  • Number of women having epidural [ Time Frame: In labour ]
  • Fetal presentation, cephalic rotation and asynclitism [ Time Frame: In labour ]
  • Vaginal and perineal ruptures after vaginal delivery [ Time Frame: Hours after delivery ]
  • Neonatal outcome [ Time Frame: Up to 28 days after delivery ]
  • Woman's experience of intervention and external cephalic version [ Time Frame: After intervention, before labour or cesarean section. ]
  • Obstetrician's rating of difficulty in performing the external cephalic version [ Time Frame: After intervention, before labour or cesarean section. ]
  • Major complications [ Time Frame: During the study ]
    Fetal demise, placental abruption, fetal distres (by CTG).


Original Secondary Outcome: Same as current

Information By: Hvidovre University Hospital

Dates:
Date Received: December 21, 2014
Date Started: March 2015
Date Completion: July 2018
Last Updated: February 23, 2017
Last Verified: February 2017