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Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

Study acronym: VVAMB
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion moved earlier from Dec 31, 2025 to Jul 28, 2022v12 Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Enrollment target: estimated 216 to confirmed 197
    • Secondary endpoints: 3 to 4
    • Site details revised
    • Study description shortened, about 1 word
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Aug 31, 2025 to Aug 31, 2026
    v11
  3. Primary completion date: Dec 31, 2022 to Dec 31, 2024
    • Study completion date: Aug 31, 2023 to Aug 31, 2025
    v10
  4. Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Study completion date: Mar 31, 2022 to Aug 31, 2023
    v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 10, 2020 to Aug 11, 2020
    v7
  2. Start date: Jul 1, 2020 to Aug 10, 2020v6
  3. Start date: Jan 1, 2020 to Jul 1, 2020v5
  4. Start date: Nov 1, 2019 to Jan 1, 2020v4
  5. Start date: Sep 1, 2019 to Nov 1, 2019
    • Primary completion date: Aug 31, 2021 to Dec 31, 2021
    • Study completion date: Dec 31, 2021 to Mar 31, 2022
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.
Trial Details
NCT Number NCT04011150
Lead Sponsor KK Women's and Children's Hospital
Conditions
(from sponsor)		 Labor Pain, Breakthrough Pain
Related terms Breakthrough Pain, Labor Pain
Enrollment 197 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov