Obstetric LaborPERIAMBUNCT02507739
Evaluation of the Impact of an Outpatient Obstetric Epidurals During Labor
A study testing no possibility to walk during labor and possibility to walk during labor in people with Obstetric Labor, run by University Hospital, Caen.
Trial summary
Mobilization, ambulation, during obstetrical work attitudes are naturally adopted by women since ancient times in many countries. The advent of the epidural in the 60s revolutionized the management of pain during childbirth. The consideration of such advance is to keep the laboring parturients lying down. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Labor
- What is being tested?
- no possibility to walk during labor and possibility to walk during labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant woman Over 18 years, beneficiary of social security / CMU
- pregnant woman Receiving the newsletter and do not express opposition.
- pregnant woman of More than 35 weeks of amenorhea, admitted to the start of work or for inducing labor
- Fetus in cephalic presentation
- pregnant woman Under ANALGESIA EPIDURAL (0.0625% levobupivacaine protocol CHU Caen)
Who cannot join
- refusal by the patient
- multiple pregnancy
- see, polyhydramnios
- unbalanced gestational hypertension, pre-eclampsia
- prematurity <35 SA
- retard Intra uterine growth
Show all 9Show fewer
- fetal Malformations
- need Internal tocometry, but especially a recording FHR intrauterine route (electrode scalp)
- RCF insufficient (<80%)
About this study
Mobilization, ambulation, during obstetrical work attitudes are naturally adopted by women since ancient times in many countries. The advent of the epidural in the 60s revolutionized the management of pain during childbirth. The consideration of such advance is to keep the laboring parturients lying down. Indeed at this time the use of high doses of local anesthetics charge of an engine block against formally allocate all up.
In a matchless analgesic efficacy during childbirth, epidurals also offers the possibility of a secure obstetrical gesture because without general anesthesia, inhalation great purveyor in these women with full stomach. These advantages explain the considerable growth in the number of epidurals performed in obstetric work in France over the last thirty years. However, this analgesia technique will soon be implicated in the alterations of obstetric mechanics, its effects depend primarily on the nature and concentration of the products used.
Read more
Evolution is then marked by a considerable reduction of concentrations of local anesthetics used with the addition of opioids, allowing to achieve an isolated analgesia without impairing motor skills, it involves the lower limbs or muscles pelvis, allowing the woman to mobilize.
Ambulatory epidural and made its appearance in the early 90. Responding to women in labor demand wishing to receive effective labor analgesia without being confined to bed, she then puts to the test the dogmas and practices on how to provide analgesia that is both effective and safe. It is now well codified and used daily in some maternity hospitals.
The mobilization of women during labor is a subject that motivates obstetric teams Caen University Hospital for many years. Motherhood has thus given the means for monitoring and ambulatory epidural analgesia protocol suitable for this technique.
The introduction of this daily care protocol opens new possibilities of care delivery hoped more physiological and less iatrogenic.
A critical evaluation of the changes possibly recorded on obstetric mechanics inherent question, motivating, for which the answers are now few and discordant in the literature.
The investigators therefore propose a randomized study evaluating single-center relative to obstetrical work typically occurring in a bed, the mobilizations of repercussions out of bed, in terms of obstetrical mechanics and comfort of the parturient.
Those will be objectified by a significant change in the working hours. This study included 560 patients is scheduled to last 2 years. Positive effects could also have repercussions in terms of public health and even of health economics.
- Conditions
- Obstetric Labor
- Being tested
- no possibility to walk during labor, possibility to walk during labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no possibility to walk during laborOther
possibility to walk during laborOther
| Study group | Role | What they receive |
|---|---|---|
| possibility to walk during labor | Other | possibility to walk during labor Receives: Other: possibility to walk during labor |
| no possibility to walk during labor | Other | no possibility to walk during labor Receives: Other: no possibility to walk during labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
labor time
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric LaborStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507739
- Sponsor's protocol ID
- 12-097
- Acronym
- PERIAMBU
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of an Outpatient Obstetric Epidurals During Labor
- ClinicalTrials.gov ID
- NCT02507739
- Acronym / sponsor ID
- PERIAMBU / 12-097
- Conditions
- Obstetric Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jul 2015 (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.
Mobilization, ambulation, during obstetrical work attitudes are naturally adopted by women since ancient times in many countries. The advent of the epidural in the 60s revolutionized the management of pain during childbirth. The consideration of such advance is to keep the laboring parturients lying down. Indeed at this time the use of high doses of local anesthetics charge of an engine block against formally allocate all up.
In a matchless analgesic efficacy during childbirth, epidurals also offers the possibility of a secure obstetrical gesture because without general anesthesia, inhalation great purveyor in these women with full stomach. These advantages explain the considerable growth in the number of epidurals performed in obstetric work in France over the last thirty years. However, this analgesia technique will soon be implicated in the alterations of obstetric mechanics, its effects depend primarily on the nature and concentration of the products used.
Evolution is then marked by a considerable reduction of concentrations of local anesthetics used with the addition of opioids, allowing to achieve an isolated analgesia without impairing motor skills, it involves the lower limbs or muscles pelvis, allowing the woman to mobilize.
Ambulatory epidural and made its appearance in the early 90. Responding to women in labor demand wishing to receive effective labor analgesia without being confined to bed, she then puts to the test the dogmas and practices on how to provide analgesia that is both effective and safe. It is now well codified and used daily in some maternity hospitals.
The mobilization of women during labor is a subject that motivates obstetric teams Caen University Hospital for many years. Motherhood has thus given the means for monitoring and ambulatory epidural analgesia protocol suitable for this technique.
The introduction of this daily care protocol opens new possibilities of care delivery hoped more physiological and less iatrogenic.
A critical evaluation of the changes possibly recorded on obstetric mechanics inherent question, motivating, for which the answers are now few and discordant in the literature.
The investigators therefore propose a randomized study evaluating single-center relative to obstetrical work typically occurring in a bed, the mobilizations of repercussions out of bed, in terms of obstetrical mechanics and comfort of the parturient.
Those will be objectified by a significant change in the working hours. This study included 560 patients is scheduled to last 2 years. Positive effects could also have repercussions in terms of public health and even of health economics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| possibility to walk during labor | Other | Other: possibility to walk during laborpossibility to walk during labor |
| no possibility to walk during labor | Other | Other: no possibility to walk during laborno possibility to walk during labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant woman Over 18 years, beneficiary of social security / CMU
- pregnant woman Receiving the newsletter and do not express opposition.
- pregnant woman of More than 35 weeks of amenorhea, admitted to the start of work or for inducing labor
- Fetus in cephalic presentation
- pregnant woman Under ANALGESIA EPIDURAL (0.0625% levobupivacaine protocol CHU Caen)
Key exclusion criteria (9 listed)
- refusal by the patient
- multiple pregnancy
- see, polyhydramnios
- unbalanced gestational hypertension, pre-eclampsia
- prematurity <35 SA
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 |
|---|---|---|
| no possibility to walk during labor | Other | no possibility to walk during labor |
| possibility to walk during labor | Other | possibility to walk during labor |
Primary outcome
labor time
Time frame: baseline
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 24 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing no possibility to walk during labor and possibility to walk during labor in people with Obstetric Labor, run by University Hospital, Caen.
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 9 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
labor time (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2015.