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Completed

NCT Number: NCT02331160

Rebozo and External Cephalic Version in Breech Presentation.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital, dept. of Obstetrics

Copenhagen, Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Rebozo

Behavioral

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

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

    Time frame: In labour

    Use of Pitocin, vacuum extraction and time frame.

  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

    Time frame: During the study

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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)

Acronym: RECeiVe

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2015
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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