NCT01291355

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

February 7, 2011

Last Update Submit

November 11, 2014

Conditions

Maternal Distress in LaborPersistent Occipitoposterior or Occipitoanterior PositionDystociaFetal Position and Presentation Abnormalities

Keywords

Maternal positionOccipitoposterior positionLaborDystociaFetal presentation Abnormalities

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Maternal comfort and pain sensation

    During the hour after the randomization

Study Arms (2)

Specific maternal position

EXPERIMENTAL

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

Control

NO INTERVENTION

Not specific intervention for this group- Only usual care

Interventions

Specific maternal position during the laborOTHER

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.

Specific maternal position

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Maternal age below 18 years old
  • Misunderstanding the French Language
  • Full dilatation of the cervix
  • Posture evaluated already adopted by the woman during labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maternity of University Hospitals

Geneva, 1211, Switzerland

Location

University Hospitals - Maternity

Geneva, 1211, Switzerland

Location

Related 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.

    PMID: 24564746RESULT

  • 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.

    PMID: 22099975RESULT

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Marie-Julia GUITTIER, PhD

    University Hospitals of Geneva-Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RM, PhD

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 8, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

CH(2)