RecruitingPhase 3

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

Singapore216 participantsStarted 2020-08-11

Plain-language summary

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.

Who can participate

Age range

21 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation); * Singleton fetus; * In early labor stage (cervical dilation ≤5cm); * Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol. Exclusion Criteria: * Non-cephalic fetal presentation; * Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications; * Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours; * Dural puncture/ suspected dural puncture at initiation of CSEA.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of motor block in each group

Timeframe: During labour (1 day)

Trial details

NCT IDNCT04011150

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Ban Leong Sng, FANZCA

+6563941081 sng.ban.leong@kkh.com.sg

View on ClinicalTrials.gov More Labor Pain trials