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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

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)


Condition or disease Intervention/treatment Phase
Maternal Distress in Labor Persistent Occipitoposterior or Occipitoanterior Position Dystocia Fetal Position and Presentation Abnormalities Other: Specific maternal position during the labor Not Applicable

Detailed Description:
Randomized clinical trial

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial
Study Start Date : February 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
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.
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.

No Intervention: Control
Not specific intervention for this group- Only usual care



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291355


Locations
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Switzerland
Maternity of University Hospitals
Geneva, Switzerland, 1211
University Hospitals - Maternity
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
University of Applied Sciences of Western Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Marie-Julia GUITTIER, PhD University Hospitals of Geneva-Switzerland

Publications of Results:
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Responsible Party: Marie-Julia GUITTIER, RM, PhD, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier: NCT01291355     History of Changes
Other Study ID Numbers: CER10-042
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Marie-Julia GUITTIER, University of Applied Sciences of Western Switzerland:
Maternal position
Occipitoposterior position
Labor
Dystocia
Fetal presentation Abnormalities
Additional relevant MeSH terms:
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Dystocia
Congenital Abnormalities
Obstetric Labor Complications
Pregnancy Complications