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Investigation of the effect of sublingual misoprostol on blood loss during abdominal myomectomy surgery

Investigation of the effect of sublingual misoprostol on blood loss during abdominal myomectomy surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240922063123N1
Enrollment
86
Registered
2024-09-29
Start date
2024-10-26
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Leiomyoma of uterus. Leiomyoma of uterus

Interventions

Intervention 1: Intervention group: 400 micrograms (2 tablets of 200 micrograms of misoprostol, Pfizer company) sublingually one hour before surgery, single dose. Intervention 2: Control group: Placeb

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 39 Years

Inclusion criteria

Inclusion criteria: Age between 20 and 39 years. A maximum of 5 uterine fibroids. Maximum diameter of the largest fibroid is 6 cm. All fibroids classified as intramural or subserosal by ultrasound uterine size less than 24 weeks of pregnancy on bimanual examination.

Exclusion criteria

Exclusion criteria: history of previous pelvic or abdominal surgery (laparotomy) history of endometriosis sensitivity to misoprostol hypertension cardiovascular or pulmonary diseases bleeding or coagulation disorders, anemia (Hb 30 kg/m²).

Design outcomes

Primary

MeasureTime frame
Clinical estimation of the amount of blood lost in CC. Timepoint: Before surgery, one hour after surgery, and 24 hours after surgery. Method of measurement: Surgical towels are weighed before and after the procedure using a scale with an accuracy of 1 gram, and the weight difference is calculated. One gram is considered equivalent to 1 milliliter of blood. The weight of empty suction bottles will be subtracted from that of filled bottles. Additionally, we will subtract the estimated blood collected on the ground as well as the volume of fluids used for irrigation from this amount.

Secondary

MeasureTime frame
Difference in hemoglobin before and after surgery. Timepoint: One and 24 hours after surgery. Method of measurement: Measurment in blood sample.;Difference in hematocrite before and after surgery. Timepoint: One and 24 hours after surgery. Method of measurement: Measurment in blood sample.;Duration of hospitalization. Timepoint: Discharge day. Method of measurement: Days.;Fever after surgery. Timepoint: One and 24 hours after surgery. Method of measurement: thermometer.;Duration of operation. Timepoint: After surgery. Method of measurement: Minutes.;Need for blood transfusion during operation. Timepoint: after surgery. Method of measurement: Surgery report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayyeh Moradpanah

Tehran University of Medical Sciences

smoradpanah@tums.ac.ir+98 21 8490 2652

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026