Rebozo and External Cephalic Version in Breech Presentation. (RECeiVe)

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.

Study Overview

• Status: Completed
• Conditions: Breech Presentation
• Intervention / Treatment: Behavioral: Rebozo

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre
    • Copenhagen, Hvidovre, Denmark, 2650
      • Hvidovre Hospital, dept. of Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rebozo; Intervention by Rebozo	Behavioral: Rebozo; Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.
No Intervention: Control; Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cephalic presentation	After external cephalic version

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Jacob Alexander Lykke, MD PhD, Ass. prof., consultant

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 21, 2014
• First Submitted That Met QC Criteria: January 3, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy; Musculoskeletal Manipulations; Medicine, Traditional; Breech Presentation; Version, fetal
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Breech Presentation
• Other Study ID Numbers: H-4-2014-101