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Maternal Positioning and Occipitoposterior Fetal Position

Primary Purpose

Maternal Distress in Labor, Persistent Occipitoposterior or Occipitoanterior Position, Dystocia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Specific maternal position during the labor
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Distress in Labor focused on measuring Maternal position, Occipitoposterior position, Labor, Dystocia, Fetal presentation Abnormalities

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maternity of University Hospitals
  • University Hospitals - Maternity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Specific maternal position

Control

Arm Description

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.

Not specific intervention for this group- Only usual care

Outcomes

Primary Outcome Measures

Fetal presentation after the intervention compare to control group
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

Maternal comfort and pain sensation
Auto-administrated questionnaire to assess comfort of the maternal position and pain related to the labor, in intervention group and control group

Full Information

First Posted
February 7, 2011
Last Updated
November 11, 2014
Sponsor
University Hospital, Geneva
Collaborators
University of Applied Sciences of Western Switzerland, Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01291355
Brief Title
Maternal Positioning and Occipitoposterior Fetal Position
Official Title
Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
University of Applied Sciences of Western Switzerland, Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Distress in Labor, Persistent Occipitoposterior or Occipitoanterior Position, Dystocia, Fetal Position and Presentation Abnormalities
Keywords
Maternal position, Occipitoposterior position, Labor, Dystocia, Fetal presentation Abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specific maternal position
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Not specific intervention for this group- Only usual care
Intervention Type
Other
Intervention Name(s)
Specific maternal position during the labor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fetal presentation after the intervention compare to control group
Description
Diagnosis of the fetal presentation will be measured by an ultra-sound one hour after the randomization in both groups: intervention and control
Time Frame
One hour after the randomization for the study
Secondary Outcome Measure Information:
Title
Maternal comfort and pain sensation
Description
Auto-administrated questionnaire to assess comfort of the maternal position and pain related to the labor, in intervention group and control group
Time Frame
During the hour after the randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Julia GUITTIER, PhD
Organizational Affiliation
University Hospitals of Geneva-Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity of University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
University Hospitals - Maternity
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24564746
Citation
Guittier MJ, Othenin-Girard V, Irion O, Boulvain M. Maternal positioning to correct occipito-posterior fetal position in labour: a randomised controlled trial. BMC Pregnancy Childbirth. 2014 Feb 24;14:83. doi: 10.1186/1471-2393-14-83.
Results Reference
result
PubMed Identifier
22099975
Citation
Guittier MJ, Othenin-Girard V. [Correcting occiput posterior position during labor: the role of maternal positions]. Gynecol Obstet Fertil. 2012 Apr;40(4):255-60. doi: 10.1016/j.gyobfe.2011.05.006. Epub 2011 Nov 17. French.
Results Reference
result

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Maternal Positioning and Occipitoposterior Fetal Position

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