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New treatment option for Labor Pain
Official title Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
ClinicalTrials.gov ID: NCT04011150
What this study is testing
What is Ropivacaine?
Ropivacaine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for labor pain.
Also referred to as Amide local anaesthetic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 50, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
- Dural puncture/ suspected dural puncture at initiation of CSEA.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.