Rebozo and External Cephalic Version in Breech Presentation.

Breech Presentation Clinical Trial

— RECeiVe  

Official title:

Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331160
• Other study ID #: H-4-2014-101
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breech Presentation

Intervention

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

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, dept. of Obstetrics	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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