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NCT04011098
Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
Phase 1 trial testing Epidural Fentanyl Bolus in Epidural in 5 participants. Terminated before completion.
2 November 2020
Quick facts
| Lead sponsor | University of Saskatchewan |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 1 July 2019 |
| Primary completion | 2 November 2020 |
| Estimated completion | 2 November 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Epidural Fentanyl Bolus — full drug profile →
- Standard Epidural Group — full drug profile →
Conditions studied
- Epidural — all drugs for Epidural →
- Labor Pain — all drugs for Labor Pain →
- Induction of Labor Affected Fetus / Newborn — all drugs for Induction of Labor Affected Fetus / Newborn →
- Obstetric Anesthesia Problems — all drugs for Obstetric Anesthesia Problems →
Sponsor
University of Saskatchewan
Who can join
Adults 18 to 40, female only, with Epidural or Labor Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04011098 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Saskatchewan
- Last refreshed: 4 November 2020
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