Rebozo and External Cephalic Version in Breech Presentation. (RECeiVe)
Primary Purpose
Breech Presentation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rebozo
Sponsored by
About this trial
This is an interventional treatment trial for Breech Presentation focused on measuring Pregnancy, Breech Presentation, Version, fetal, Musculoskeletal Manipulations, Medicine, Traditional
Eligibility Criteria
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.
Sites / Locations
- Hvidovre Hospital, dept. of Obstetrics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rebozo
Control
Arm Description
Intervention by Rebozo
Standard
Outcomes
Primary Outcome Measures
Cephalic presentation
Secondary Outcome Measures
Version rate by the intervention only
Version rate by the standard external cephalic version
Rate of cesarean section by intervention and presentation.
Dystocia in labor in cephalic presentation after version
Use of Pitocin, vacuum extraction and time frame.
Inducement of labour
Time frames for rupture of membranes, labour, first and second stage labour
Number of women having epidural
Fetal presentation, cephalic rotation and asynclitism
Vaginal and perineal ruptures after vaginal delivery
Neonatal outcome
Woman's experience of intervention and external cephalic version
Obstetrician's rating of difficulty in performing the external cephalic version
Major complications
Fetal demise, placental abruption, fetal distres (by CTG).
Full Information
NCT ID
NCT02331160
First Posted
December 21, 2014
Last Updated
February 20, 2019
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02331160
Brief Title
Rebozo and External Cephalic Version in Breech Presentation.
Acronym
RECeiVe
Official Title
Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
Pregnancy, Breech Presentation, Version, fetal, Musculoskeletal Manipulations, Medicine, Traditional
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rebozo
Arm Type
Experimental
Arm Description
Intervention by Rebozo
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard
Intervention Type
Behavioral
Intervention Name(s)
Rebozo
Intervention Description
Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.
Primary Outcome Measure Information:
Title
Cephalic presentation
Time Frame
After external cephalic version
Secondary Outcome Measure Information:
Title
Version rate by the intervention only
Time Frame
Before external cephalic version
Title
Version rate by the standard external cephalic version
Time Frame
At the external cephalic version
Title
Rate of cesarean section by intervention and presentation.
Time Frame
In labour
Title
Dystocia in labor in cephalic presentation after version
Description
Use of Pitocin, vacuum extraction and time frame.
Time Frame
In labour
Title
Inducement of labour
Time Frame
Before labour
Title
Time frames for rupture of membranes, labour, first and second stage labour
Time Frame
In Labour
Title
Number of women having epidural
Time Frame
In labour
Title
Fetal presentation, cephalic rotation and asynclitism
Time Frame
In labour
Title
Vaginal and perineal ruptures after vaginal delivery
Time Frame
Hours after delivery
Title
Neonatal outcome
Time Frame
Up to 28 days after delivery
Title
Woman's experience of intervention and external cephalic version
Time Frame
After intervention, before labour or cesarean section.
Title
Obstetrician's rating of difficulty in performing the external cephalic version
Time Frame
After intervention, before labour or cesarean section.
Title
Major complications
Description
Fetal demise, placental abruption, fetal distres (by CTG).
Time Frame
During the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Alexander Lykke, MD PhD
Organizational Affiliation
Ass. prof., consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital, dept. of Obstetrics
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Rebozo and External Cephalic Version in Breech Presentation.
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