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CompletedNCT02331160RECeiVeUpdated Feb 22, 2019

Rebozo and External Cephalic Version in Breech Presentation.

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

Phase
Not applicable
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breech Presentation

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Keywords

  • Pregnancy
  • Breech Presentation
  • Version, fetal
  • Musculoskeletal Manipulations
  • Medicine, Traditional
03

In context

Breech Presentation

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 →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Understands Danish in writing.
  • Intention of accepting vaginal delivery if cephalic presentation.
  • Can be offered standard treatment of external cephalic version according to local guidelines, e.g.:

    • Singleton pregnancy
    • Fetus in breech or transverse position
  • The gestational age at randomization must be between 35w+0/7d and 37w+4/7d so that the ECV is no later than 38w+0/7d for parous and 37w + 0/7d for nulliparous women.

Exclusion criteria

Exclusion Criteria:

  • Women that cannot be offered external cephalic version according local guideline, e.g.:

    • placenta praevia and vasa praevia.
    • Suspicion of severe fetal growth restriction.
    • Severe preeclampsia.
    • Uterus anomalies.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
370 participants (actual)

Study arms

  • Experimental
    Rebozo

    Intervention by Rebozo

    Behavioral: Rebozo

  • No intervention
    Control

    Standard

Interventions

  • BehavioralRebozo

    Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.

06

What researchers measure

Primary outcomes

  1. Cephalic presentation

    Time frame: After external cephalic version

Secondary outcomes

  1. Version rate by the intervention only

    Time frame: Before external cephalic version

  2. Version rate by the standard external cephalic version

    Time frame: At the external cephalic version

  3. Rate of cesarean section by intervention and presentation.

    Time frame: In labour

  4. Dystocia in labor in cephalic presentation after version

    Use of Pitocin, vacuum extraction and time frame.

    Time frame: In labour

  5. Inducement of labour

    Time frame: Before labour

  6. Time frames for rupture of membranes, labour, first and second stage labour

    Time frame: In Labour

  7. Number of women having epidural

    Time frame: In labour

  8. Fetal presentation, cephalic rotation and asynclitism

    Time frame: In labour

  9. Vaginal and perineal ruptures after vaginal delivery

    Time frame: Hours after delivery

  10. Neonatal outcome

    Time frame: Up to 28 days after delivery

  11. Woman's experience of intervention and external cephalic version

    Time frame: After intervention, before labour or cesarean section.

  12. Obstetrician's rating of difficulty in performing the external cephalic version

    Time frame: After intervention, before labour or cesarean section.

  13. Major complications

    Fetal demise, placental abruption, fetal distres (by CTG).

    Time frame: During the study

07

Study locations

1 site
  • Hvidovre Hospital, dept. of Obstetrics
    Copenhagen, Hvidovre 2650, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Dec 2018, 45 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2014
First posted
Jan 6, 2015
StartActual
Mar 2015
Primary completionActual
Dec 31, 2018
CompletionActual
Dec 31, 2018
Last update
Feb 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02331160
Responsible party
Jacob Alexander Lykke (Ass. professor, consultant, MD PhD, Hvidovre University Hospital) — Principal investigator
First posted
Jan 6, 2015
Start date
Mar 2015
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Feb 22, 2019

Study contacts

Jacob Alexander Lykke, MD PhD
principal investigator · Ass. prof., consultant

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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