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NCT06285396
Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study
NA trial testing Ephedrine in Postpartum Hemorrhage in 96 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 18 March 2024 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Ephedrine (EPHEDRINE) — full drug profile →
- Phenylephrine (phenylephrine) — full drug profile →
- Norepinephrine (NOREPINEPHRINE) — full drug profile →
- Oxytocin (OXYTOCIN) — full drug profile →
Conditions studied
- Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Who can join
Adults 19 to 45, female only, with Postpartum Hemorrhage. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Motility index
Time frame: 4 hours
Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Sponsor's own description
The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes. Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH. It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06285396
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ephedrine
Trials testing the same drug.
- NCT06921473 — Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia · Phase 4 · completed
- NCT06844201 — Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine · not yet recruiting
- NCT06741410 — Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery · completed
- NCT06498076 — Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section: Baby Norepinephrine Versus Ephedrine · NA · recruiting
- NCT07034911 — Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery · Phase 1 · completed
Other recruiting trials for Postpartum Hemorrhage
Currently open trials in the same condition.
- NCT07401160 — Umbilical Cord Drainage to Prevent Postpartum Hemorrhage · NA · recruiting
- NCT07278037 — Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage · recruiting
- NCT07279545 — The Effect of Placental Cord Drainage on the Third Stage of Labor and the Amount of Postpartum Bleeding · NA · recruiting
- NCT07229573 — The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management · NA · recruiting
- NCT07005349 — THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage · NA · recruiting
Other Samuel Lunenfeld Research Institute, Mount Sinai Hospital trials
Trials by the same sponsor.
- NCT06589687 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery · completed
- NCT06589661 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery · completed
- NCT06368583 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analges · completed
- NCT06368570 — The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery · completed
- NCT06318715 — Modified Deep Extubation vs. Standard Awake Extubation · NA · recruiting
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 NCT06285396 (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 Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Last refreshed: 31 March 2026
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/NCT06285396.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing