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Completed

NCT Number: NCT02264834

Deambulatory Epidural During the Labour

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

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Key information

Conditions

First Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHUB

Brussels, 1020, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Levobupivacaine 0.1% + Sufentanil 0.2µg/ml

Drug

Levobupivacaine 0.1% + Sufentanil 0.2µg/ml

Other names: control group

Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

Drug

Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

Other names: ambulatory group

Lumbar epidural analgesia

Procedure

Introduction of a catheter in lumbar epidural space

Other names: labor analgesia

Primary outcomes

  1. Time between peridural application and childbirth

    Time frame: at delivery

    This will be used to assess labor.

  2. Caesarian

    Time frame: at delivery

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

  3. Instrumentalisation

    Time frame: at delivery

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

  4. Apgar score of the baby

    Time frame: at delivery

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

Secondary outcomes

  1. Bromage score

    Time frame: 1h after the start of the peridural

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

  2. Romberg test

    Time frame: 1h after the start of the peridural

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

  3. Arterial tension

    Time frame: 1h after the start of the peridural

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

Sponsors and collaborators

Lead sponsor

Dr Madeleine Wilwerth

Other

Registry information

Official study title

Comparison of Two Different Peridural During the Labor and Effect of Deambulation

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2014
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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