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NCT02958215
A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine
Phase 2 trial testing Phenylephrine in Anesthesia, Obstetrical in 980 participants. Completed in 1 May 2017.
1 May 2017
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 980 |
| Start date | 1 June 2016 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 May 2017 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Phenylephrine (phenylephrine) — full drug profile →
- Placebo
Conditions studied
- Anesthesia, Obstetrical — all drugs for Anesthesia, Obstetrical →
- Anesthesia, Spinal — all drugs for Anesthesia, Spinal →
Sponsor
Assiut University
Who can join
Adults 18 to 50, female only, with Anesthesia, Obstetrical or Anesthesia, Spinal. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of hypotension
Time frame: within first 24 hours after spinal anesthesia
blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
Sponsor's own description
Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia
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 NCT02958215
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Phenylephrine
Trials testing the same drug.
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- NCT07033845 — Pharmacokinetic Study of Topical Phenylephrine · EARLY_PHASE1 · recruiting
- NCT06158009 — ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment · NA · unknown
- NCT06508359 — Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension. · NA · not yet recruiting
Other recruiting trials for Anesthesia, Obstetrical
Currently open trials in the same condition.
- NCT03167905 — CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery) · Phase 2, PHASE3 · active not recruiting
Other Assiut University trials
Trials by the same sponsor.
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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 NCT02958215 (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 Assiut University
- Last refreshed: 16 May 2017
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/NCT02958215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing