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Prevention of HEMOrhagic risk in upper MYOmeCTomy by use of Misoprostol.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513617-13-00
Acronym
RBHP 2024 GREMEAU
Enrollment
80
Registered
2024-12-19
Start date
2025-04-14
Completion date
Unknown
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fibroma

Brief summary

Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.

Detailed description

Depending on the randomization group, compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level, Depending on the randomization group, compare: Demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment., Depending on the randomization group, compare: Characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas., Depending on the randomization group, compare the duration between taking the tablet and anesthetic induction then the incision, Depending on the randomization group, compare the duration between incision or pneumoperitoneum and closure, Depending on the randomization group, compare the accounting for the number of RGCs transfused., Depending on the randomization group, compare the collection of early postoperative complications., Depending on the randomization group, compare : EVA at H+2, H+6 D1 M1., Depending on the randomization group, compare : Length of hospitalization in days., Depending on the type of surgery compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level, Depending on the type of surgery compare the demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment., Depending on the type of surgery compare the characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas., Depending on the type of surgery compare the duration between taking the tablet and anesthetic induction then the incision, Depending on the type of surgery compare the duration between incision or pneumoperitoneum and closure., Depending on the type of surgery compare the accounting for the number of RGCs transfused., Depending on the type of surgery compare the collection of early postoperative complications., Depending on the type of surgery compare EVA at H+2, H+6 D1 M1, Depending on the type of surgery compare the length of hospitalization in days., Intraoperative blood loss measured in mL (volume in aspiration and blood volumes in compresses after weighing) according to the randomization group and surgical technique.

Interventions

DRUGPLACEBO
DRUGMisoOne 400 mikrogramų tabletės

Sponsors

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.

Secondary

MeasureTime frame
Depending on the randomization group, compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level, Depending on the randomization group, compare: Demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment., Depending on the randomization group, compare: Characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas., Depending on the randomization group, compare the duration between taking the tablet and anesthetic induction then the incision, Depending on the randomization group, compare the duration between incision or pneumoperitoneum and closure, Depending on the randomization group, compare the accounting for the number of RGCs transfused., Depending on the randomization group, compare the collection of early postoperative complications., Depending on the randomization group, compare : EVA at H+2, H+6 D1 M1., Depending on

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026