Maternal Positioning and Occipitoposterior Fetal Position

Dystocia Clinical Trial

Official title:

Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291355
• Other study ID #: CER10-042
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: November 11, 2014
• Start date: February 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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)

Description:

Randomized clinical trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Dystocia
• Fetal Position and Presentation Abnormalities
• Maternal Distress in Labor
• Persistent Occipitoposterior or Occipitoanterior Position

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Maternity of University Hospitals	Geneva
Switzerland	University Hospitals - Maternity	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Science Foundation, University of Applied Sciences of Western Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One hour after the randomization for the study	No
Secondary	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	During the hour after the randomization	No