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Maternal Positioning and Occipitoposterior Fetal Position

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ClinicalTrials.gov Identifier: NCT01291355
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : November 13, 2014
Sponsor:
Collaborators:
University of Applied Sciences of Western Switzerland
Swiss National Science Foundation
Information provided by (Responsible Party):
Marie-Julia GUITTIER, University of Applied Sciences of Western Switzerland

Tracking Information
First Submitted Date  ICMJE February 7, 2011
First Posted Date  ICMJE February 8, 2011
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
Fetal presentation after the intervention compare to control group [ Time Frame: One hour after the randomization for the study ]
Diagnosis of the fetal presentation will be measured by an ultra-sound one hour after the randomization in both groups: intervention and control
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
Maternal comfort and pain sensation [ Time Frame: During the hour after the randomization ]
Auto-administrated questionnaire to assess comfort of the maternal position and pain related to the labor, in intervention group and control group
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 Maternal Positioning and Occipitoposterior Fetal Position
Official Title  ICMJE Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial
Brief Summary

The aim of the study is to evaluate the efficacy of a specific maternal position to correct fetal position in occipito-posterior during the labor.

The investigators hypothesize that the maternal position described by the Dr de Gasquet facilitate the rotation in occipito-anterior during the labor.

The calculated sample size is 438 participants (219 in each group)

Detailed Description Randomized clinical trial
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
  • Maternal Distress in Labor
  • Persistent Occipitoposterior or Occipitoanterior Position
  • Dystocia
  • Fetal Position and Presentation Abnormalities
Intervention  ICMJE Other: Specific maternal position during the labor
women allocated to intervention group will be invited to adopt a posture all fours type:"support on the knees, torso tilted forward, back stretched" for a minimum of 10 minutes. A cushion is placed between the legs of the woman to limit the cuts.
Study Arms  ICMJE
  • Experimental: Specific maternal position
    women allocated to intervention group will be invited to adopt a posture all fours type:"support on the knees, torso tilted forward, back stretched" for a minimum of 10 minutes. A cushion is placed between the legs of the woman to limit the cuts. According to Dr de Gasquet, author of the description of this posture, the effect on the variety of presentation would be almost immediate.
    Intervention: Other: Specific maternal position during the labor
  • No Intervention: Control
    Not specific intervention for this group- Only usual care
Publications *

*   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 7, 2011)
438
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • singleton
  • primiparous and multiparous
  • Term ≥ 37 weeks
  • Labor in dilatation phase (cervix effaced, permeable finger 2 to 9 cm)
  • Diagnosis of occipitoposterior variety confirmed by ultrasound

Exclusion Criteria:

  • Maternal age below 18 years old
  • Misunderstanding the French Language
  • Full dilatation of the cervix
  • Posture evaluated already adopted by the woman during labor
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291355
Other Study ID Numbers  ICMJE CER10-042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marie-Julia GUITTIER, University of Applied Sciences of Western Switzerland
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE
  • University of Applied Sciences of Western Switzerland
  • Swiss National Science Foundation
Investigators  ICMJE
Principal Investigator: Marie-Julia GUITTIER, PhD University Hospitals of Geneva-Switzerland
PRS Account University Hospital, Geneva
Verification Date November 2014

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