An interventional study of Rebozo in Breech Presentation, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment
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.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 370 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
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Can be offered standard treatment of external cephalic version according to local guidelines, e.g.:
Exclusion Criteria:
Women that cannot be offered external cephalic version according local guideline, e.g.:
Intervention by Rebozo
Behavioral: Rebozo
Standard
Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.
Cephalic presentation
Time frame: After external cephalic version
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
Use of Pitocin, vacuum extraction and time frame.
Time frame: In labour
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
Fetal demise, placental abruption, fetal distres (by CTG).
Time frame: During the study
Ran from Mar 2015 to primary completion in Dec 2018, 45 months.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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