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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02331160
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jacob Alexander Lykke, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE December 21, 2014
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2015)
Cephalic presentation [ Time Frame: After external cephalic version ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2015)
  • 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 ]
    Use of Pitocin, vacuum extraction and time frame.
  • 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 ]
    Fetal demise, placental abruption, fetal distres (by CTG).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rebozo and External Cephalic Version in Breech Presentation.
Official Title  ICMJE Rebozo Som Vendingsmetode Ved sædepræsentation (in Danish)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breech Presentation
Intervention  ICMJE Behavioral: Rebozo
Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.
Study Arms  ICMJE
  • Experimental: Rebozo
    Intervention by Rebozo
    Intervention: Behavioral: Rebozo
  • No Intervention: Control
    Standard
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2019)
370
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2015)
378
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331160
Other Study ID Numbers  ICMJE H-4-2014-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacob Alexander Lykke, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacob Alexander Lykke, MD PhD Ass. prof., consultant
PRS Account Hvidovre University Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP