Breech PresentationRECeiVeNCT02331160
Rebozo and External Cephalic Version in Breech Presentation.
A study testing Rebozo in people with Breech Presentation, run by Hvidovre University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Rebozo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital, dept. of Obstetrics
Copenhagen, Hvidovre, 2650
About this study
Official title: 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.
Read more
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.
- Conditions
- Breech Presentation
- Being tested
- Rebozo
- Keywords
- Pregnancy, Breech Presentation, Version, fetal, Musculoskeletal Manipulations, Medicine, Traditional
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebozoBehavioural
Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.
| Study group | Role | What they receive |
|---|---|---|
| Rebozo | Experimental | Intervention by Rebozo Receives: Behavioral: Rebozo |
| Control | No intervention | Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic presentation
Measured: After external cephalic version
Secondary outcomes (13)
Version rate by the intervention only
Measured: Before external cephalic version
Version rate by the standard external cephalic version
Measured: At the external cephalic version
Rate of cesarean section by intervention and presentation.
Measured: In labour
Dystocia in labor in cephalic presentation after version
Use of Pitocin, vacuum extraction and time frame.
Measured: In labour
Inducement of labour
Measured: Before labour
Time frames for rupture of membranes, labour, first and second stage labour
Measured: In Labour
Number of women having epidural
Measured: In labour
Fetal presentation, cephalic rotation and asynclitism
Measured: In labour
Vaginal and perineal ruptures after vaginal delivery
Measured: Hours after delivery
Neonatal outcome
Measured: Up to 28 days after delivery
Woman's experience of intervention and external cephalic version
Measured: After intervention, before labour or cesarean section.
Obstetrician's rating of difficulty in performing the external cephalic version
Measured: After intervention, before labour or cesarean section.
Major complications
Fetal demise, placental abruption, fetal distres (by CTG).
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Alexander Lykke, Hvidovre University Hospital
- Investigators
- Jacob Alexander Lykke, MD PhD, Principal investigator, Ass. prof., consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331160
- Sponsor's protocol ID
- H-4-2014-101
- Acronym
- RECeiVe
- Status last verified
- Feb 2019
- First submitted
- 21 Dec 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)
- ClinicalTrials.gov ID
- NCT02331160
- Acronym / sponsor ID
- RECeiVe / H-4-2014-101
- Conditions
- Breech Presentation
- Keywords
- Pregnancy, Breech Presentation, Version, fetal, Musculoskeletal Manipulations, Medicine, Traditional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebozo | Experimental | Behavioral: RebozoIntervention by Rebozo |
| Control | No intervention | –Standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.:
- 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.
Key exclusion criteria (5 listed)
- Women that cannot be offered external cephalic version according local guideline, e.g.:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebozoShaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation. | Behavioural | Rebozo |
Primary outcome
Cephalic presentation
Time frame: After external cephalic version
13 secondary outcomes
Version rate by the intervention only
Time frame: Before external cephalic version
Version rate by the standard external cephalic version
Time frame: At the external cephalic version
Rate of cesarean section by intervention and presentation.
Time frame: In labour
Dystocia in labor in cephalic presentation after version
Time frame: In labour
Inducement of labour
Time frame: Before labour
Time frames for rupture of membranes, labour, first and second stage labour
Time frame: In Labour
Number of women having epidural
Time frame: In labour
Fetal presentation, cephalic rotation and asynclitism
Time frame: In labour
Vaginal and perineal ruptures after vaginal delivery
Time frame: Hours after delivery
Neonatal outcome
Time frame: Up to 28 days after delivery
Woman's experience of intervention and external cephalic version
Time frame: After intervention, before labour or cesarean section.
Obstetrician's rating of difficulty in performing the external cephalic version
Time frame: After intervention, before labour or cesarean section.
Major complications
Time frame: During the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Alexander Lykke, MD PhD principal investigator
Ass. prof., consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebozo in people with Breech Presentation, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cephalic presentation (time frame: After external cephalic version). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.