Maternal Positioning and Occipitoposterior Fetal Position

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Completed
• CT.gov ID: NCT01291355
• Collaborator: University of Applied Sciences of Western Switzerland (Other), Swiss National Science Foundation (Other)
• Enrollment: 438
• Locations: 2
• Arms: 2
• Duration (Months): 44
• Patients Per Site: 219
• Patients Per Site Per Month: 5

Study Details

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)

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	N/A

Detailed Description

Randomized clinical trial

Study Design

• Study Type: Interventional
• 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: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fetal presentation after the intervention compare to control group [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternity of University Hospitals	Geneva		Switzerland	1211
2	University Hospitals - Maternity	Geneva		Switzerland	1211

Sponsors and Collaborators

• University Hospital, Geneva
• University of Applied Sciences of Western Switzerland
• Swiss National Science Foundation

Investigators

• Principal Investigator: Marie-Julia GUITTIER, PhD, University Hospitals of Geneva-Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marie-Julia GUITTIER, RM, PhD, University of Applied Sciences of Western Switzerland
• ClinicalTrials.gov Identifier: NCT01291355
• Other Study ID Numbers: CER10-042
• First Posted: Feb 8, 2011
• Last Update Posted: Nov 13, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Marie-Julia GUITTIER, RM, PhD, University of Applied Sciences of Western Switzerland: Maternal position; Occipitoposterior position; Labor; Dystocia; Fetal presentation Abnormalities
• Additional relevant MeSH terms: Dystocia; Congenital Abnormalities

Study Results

No Results Posted as of Nov 13, 2014