TerminatedPhase 1

Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour

Stopped: Unable to meet recruitment numbers, lack of participation

Canada5 participantsStarted 2019-07-01

Plain-language summary

Labour pain can be intensified for labour inductions and women undergoing inductions often have earlier and more frequent requests for analgesia. Current evidence suggests that epidural analgesia effectively manages pain in labour, but may give rise to adverse effects for both the mother and neonate. Opioids are often added to epidurals to improve the quality of analgesia. Despite reassuring findings regarding epidural opioids, other investigators have found an association between epidural opioids and neonatal respiratory distress, lower Neurological and Adaptive Capacity scores, and reduced rates of breastfeeding. Given the heightened implications for the mother and neonate in situations requiring induction of labour, the desire for a positive outcome whilst still providing adequate maternal analgesia is paramount. This study thus aims to investigate whether a preliminary epidural Fentanyl bolus at the initiation of the epidural may help to improve analgesia for women undergoing labour inductions for post-term pregnancy in a safe manner. Importantly, the main rationale of this proposed practice being that by achieving adequate epidural analgesia earlier in the labour induction, this may lead to better pain control overall and less overall requirements for epidural PCEA boluses and epidural "top-ups" as the induction progresses.

Who can participate

Age range

18 Years – 40 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 parturients * Parturients presenting for labour induction for post-term pregnancy (i.e. pregnancy beyond 42 weeks gestational age) * Parturients who have had an uncomplicated pregnancy Exclusion Criteria: * Parturients presenting for induction of labour for pre-labour (premature) rupture of membranes * Parturients presenting for induction of labour for hypertensive disorders of pregnancy \[including preeclampsia, eclampsia, HELLP syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets)\] * Parturients with maternal diabetes * Fetal growth restriction * Multiple gestation pregnancy * Known or suspected Chorioamnionitis * Known or suspected Abruptio placentae * Oligohydramnios * Parturients with cholestasis of pregnancy * Known alloimmunization with fetal effects. * Parturients with other chronic medical conditions or any complications related to pregnancy * Participants who lack capacity to consent on their own behalf

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

Labour analgesia quality: Change in verbal rating pain scale (VRS) after epidural placement

Timeframe: Verbal rating pain scale will be assessed 1) Prior to epidural placement, 2) 20 minutes after epidural placement, 3) 60 minutes after epidural placement, and 4) 120 minutes after epidural placement

Trial details

NCT IDNCT04011098

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-02

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