Breech Presentation Clinical Trial
Official title:
Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)
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
presentation;all women who fulfill the local guideline criteria for external cephalic
version, can be included. Exclusion criteria are non-Danish speaking or reading.
The recruitment will be conducted by midwife at week 35 in the antenatal care. The study
design will be open-labeled randomized controlled. Randomisation is done by "closed envelope
method" and stratified by parity. Intervention is rebozo exercises performed over 3-5 days
from randomization. In case of persistent breech presentation, the woman is offered standard
external cephalic version. The control group will also be offered external cephalic version
after 3-5 days from randomization.
The investigators will use source data from existing local databases, "Obstetrics Database"
and "version Database", for collecting birth outcome. In all stages of intervention
documented electronically by project midwives.
The primary objective is the number of successful versions in total, i.e., after intervention
and external cephalic version. We expect to increase the success rate from 50% to 65%, thus
requiring 378 women in the study.
Secondary objectives are the number of successful vaginal births with birth in head position
and total number of caesarean.
n/a
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