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Dinoprostone vs Misoprostol for Bleeding in Abdominal Myomectomy
NCT05761418Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2018
- Primary completion
- Feb 2023
- Countries
- 1
- Sponsor
- Beni Suef University
- Modality
- Small Molecules
- Conditions
- Uterine Fibroids (UF)
01
Overview
Phase 3, randomised, double-blind trial of dinoprostone and misoprostol in Uterine Fibroids (UF) (3 arms), sponsored by Beni Suef University. Primary endpoint: Intraoperative Blood Loss. Started Mar 2018; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Dinoprostone
20 mg Dinoprostone vaginally
Misoprostol
400 ug Misoprostol vaginally
Control
Placebo vaginally
03
Who it enrols
Women aged 30-50 with uterine fibroids indicated for myomectomy, excluding those with active PID, endometriosis, prior myomectomy, or recent use of mifepristone, GnRH analogs, or oral contraceptives.
04
Endpoints
Primary
Intraoperative Blood Loss
Secondary
Change in Hemoglobin Levels
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