Maternal Distress in LaborNCT01291355
Maternal Positioning and Occipitoposterior Fetal Position
A study testing Specific maternal position during the labor in people with Maternal Distress in Labor and Persistent Occipitoposterior or Occipitoanterior Position, run by University Hospital, Geneva at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Distress in Labor, Persistent Occipitoposterior or Occipitoanterior Position, Dystocia
- What is being tested?
- Specific maternal position during the labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Maternal age below 18 years old
- Misunderstanding the French Language
- Full dilatation of the cervix
- Posture evaluated already adopted by the woman during labor
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Maternity of University Hospitals
Geneva, 1211
University Hospitals - Maternity
Geneva, 1211
About this study
Official title: Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial
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)
Read the detailed description
Randomized clinical trial
- Conditions
- Maternal Distress in Labor, Persistent Occipitoposterior or Occipitoanterior Position, Dystocia, Fetal Position and Presentation Abnormalities
- Being tested
- Specific maternal position during the labor
- Keywords
- Maternal position, Occipitoposterior position, Labor, Dystocia, Fetal presentation Abnormalities
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Specific maternal position during the labor |
| Control | No intervention | Not specific intervention for this group- Only usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One hour after the randomization for the study
Secondary outcomes (1)
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
Measured: During the hour after the randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal Distress in LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, Swiss National Science Foundation
- Responsible party
- Principal investigator, Marie-Julia GUITTIER, University of Applied Sciences of Western Switzerland
- Investigators
- Marie-Julia GUITTIER, PhD, Principal investigator, University Hospitals of Geneva-Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291355
- Sponsor's protocol ID
- CER10-042
- Status last verified
- Nov 2014
- First submitted
- 7 Feb 2011
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24564746Guittier 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.
PubMed 22099975
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01291355
- Acronym / sponsor ID
- CER10-042
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, Swiss National Science Foundation
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific maternal position | Experimental | Other: Specific maternal position during the laborwomen 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. |
| Control | No intervention | –Not specific intervention for this group- Only usual care |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Maternal age below 18 years old
- Misunderstanding the French Language
- Full dilatation of the cervix
- Posture evaluated already adopted by the woman during labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific maternal position during the laborwomen 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. | Other | Specific maternal position |
Primary outcome
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
1 secondary outcome
Maternal comfort and pain sensation
Time frame: During the hour after the randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Results publication: PubMed 24564746Guittier 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 publication: PubMed 22099975Guittier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Julia GUITTIER, PhD principal investigator
University Hospitals of Geneva-Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific maternal position during the labor in people with Maternal Distress in Labor and Persistent Occipitoposterior or Occipitoanterior Position, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal presentation after the intervention compare to control group (time frame: One hour after the randomization for the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291355, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.