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NCT03957083
Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2
NA trial testing Oxytocin in Postpartum Hemorrhage in 30 participants. Completed in 4 February 2020.
3 February 2020
Quick facts
| Lead sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 26 June 2019 |
| Primary completion | 3 February 2020 |
| Estimated completion | 4 February 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Oxytocin (OXYTOCIN) — full drug profile →
Conditions studied
- Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →
- Obesity — all drugs for Obesity →
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Who can join
Adults 18 to 50, female only, with Postpartum Hemorrhage or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2. The investigators seek to find the best dose for patients with a BMI\>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately.
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 NCT03957083
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxytocin
Trials testing the same drug.
- NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
- NCT07188207 — Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section · NA · not yet recruiting
- NCT06968481 — Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage · Phase 2 · not yet recruiting
- NCT07265180 — Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison · NA · recruiting
- NCT07119398 — Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM · Phase 4 · recruiting
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 NCT03957083 (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: 6 February 2020
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/NCT03957083.
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