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NCT02563821: PCEA-IMG
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)
Phase 3 trial testing Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia in Anesthesia, Epidural in 37 participants. Completed in 11 December 2018.
11 December 2018
Quick facts
| Lead sponsor | University Hospital, Limoges |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 5 November 2015 |
| Primary completion | 11 December 2018 |
| Estimated completion | 11 December 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
- Levobupivacaine (LEVOBUPIVACAINE) — full drug profile →
- sufentanil (SUFENTANIL) — full drug profile →
- clonidine (CLONIDINE) — full drug profile →
- epidural catheter — full drug profile →
Conditions studied
- Anesthesia, Epidural — all drugs for Anesthesia, Epidural →
Sponsor
University Hospital, Limoges
Who can join
18 and older, female only, with Anesthesia, Epidural. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI). Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy. We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02563821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02563821 (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 Hospital, Limoges
- Last refreshed: 22 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02563821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing