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First PregnancyPhase 3NCT02264834

Deambulatory Epidural During the Labour

A Phase 3 study testing Levobupivacaine 0.1% + Sufentanil 0.2µg/ml, Levobupivacaine 0.07% + Sufentanil 0.3µg/ml and Lumbar epidural analgesia in people with First Pregnancy, run by Dr Madeleine Wilwerth at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
First Pregnancy
What is being tested?
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml, Levobupivacaine 0.07% + Sufentanil 0.3µg/ml and Lumbar epidural analgesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteBelgium
Study dates
1 Jul 2014to 20 Mar 2018
Phase
Phase 3
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Free written consent.
  • ASA I or II,
  • Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm
  • VAS> 30 mm
  • No contraindications to peridural

Who cannot join

  • Twin pregnancy, less than 36 weeks and 42 weeks
  • Fetus in breech position
  • Analgesia and sedation within 6h
  • Contraindications to peridural

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHUB

    Brussels, 1020

Other trials in Belgium

About this study

Official title: Comparison of Two Different Peridural During the Labor and Effect of Deambulation

Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block.

Read the detailed description

Prospective, randomized and double-blind study performed on primiparous parturient divided into two distinct groups.

Conditions
First Pregnancy
Being tested
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml, Levobupivacaine 0.07% + Sufentanil 0.3µg/ml, Lumbar epidural analgesia
Keywords
epidural, primiparous patient, deambulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levobupivacaine 0.1% + Sufentanil 0.2µg/mlDrug

    Also called control group

    Levobupivacaine 0.1% + Sufentanil 0.2µg/ml

  • Levobupivacaine 0.07% + Sufentanil 0.3µg/mlDrug

    Also called ambulatory group

    Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

  • Lumbar epidural analgesiaProcedure or surgery

    Also called labor analgesia

    Introduction of a catheter in lumbar epidural space

Study groups in NCT02264834
Study groupRoleWhat they receive
Control groupActive comparatorLumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL
Receives: Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml; Procedure: Lumbar epidural analgesia
Ambulatory groupExperimentalLumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL
Receives: Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml; Procedure: Lumbar epidural analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time between peridural application and childbirth

    This will be used to assess labor.

    Measured: at delivery

  2. Caesarian

    This will be used to assess labor. Was a caesarian necessary (yes-no) ?

    Measured: at delivery

  3. Instrumentalisation

    This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ?

    Measured: at delivery

  4. Apgar score of the baby

    Evaluation of the baby, using the Apgar score. This will be used to assess labor.

    Measured: at delivery

Secondary outcomes (3)

  1. Bromage score

    Modified Bromage score (Breen et al) >5 and ability to stand on one leg alternatively. This will be used to assess perambulation (motricity).

    Measured: 1h after the start of the peridural

  2. Romberg test

    Romberg test during 20-30 seconds. This will be used to assess perambulation (proprioception).

    Measured: 1h after the start of the peridural

  3. Arterial tension

    Absence of orthostatic hypotension (i-e less than 20% of the usual arterial tension of the patient).

    Measured: 1h after the start of the peridural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion20 Mar 2018
  4. Study completion20 Mar 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264834
Sponsor's protocol ID
PDB001
Status last verified
May 2018
First submitted
1 Aug 2014
Last updated
31 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levobupivacaine 0.1% + Sufentanil 0.2µg/ml, Levobupivacaine 0.07% + Sufentanil 0.3µg/ml and Lumbar epidural analgesia in people with First Pregnancy, run by Dr Madeleine Wilwerth at 1 site in Belgium.

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 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Time between peridural application and childbirth (time frame: at delivery). The study lists 4 primary outcomes in all. 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 NCT02264834.

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 31 May 2018.

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