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Randomize clinical trial comparing Misoprostol+ Vasoprssine with Vasopressine alone to decrease bleeding at minimally invasive myomectomy

Randomize clinical trial comparing Misoprostol+ Vasoprssine with Vasopressine alone to decrease bleeding at minimally invasive myomectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015062222871N1
Enrollment
80
Registered
2016-10-19
Start date
2016-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Leiomyoma of uterus. benign neoplasms of uterus with morphology code M889 and behaviour code /0 fibromyoma of uterus

Interventions

Intervention 1: The procedure is described to patients and council form is taken. An evaluation sheet including history, para clinic and out comes is filled out for all of women who were scheduled
Treatment - Drugs
The procedure is described to patients and council form is taken. An evaluation sheet including history, para clinic and out comes is filled out for all of women who were scheduled to undergo myome

Sponsors

Vice chancellor for research,Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 18-55 years old women; with symptomatic uterine mayoma; with out any contraindication for laparoscopy, Misoprostol or Vasopressine Exclusion criteria:any contraindication for laparoscopy; any contraindication for Misoprostol; any contraindication for Vasopressine;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Blood loss during surgery. Timepoint: End of surgery. Method of measurement: Volume of blood in suction & bloody sponge count.;Hb drop after surgery. Timepoint: Befor & 6 hour after surgery. Method of measurement: gr/ dl from blood specimen; before and 6 hour after surgery.

Secondary

MeasureTime frame
Post operative complication. Timepoint: From transfer of patient to ward till two weeks after surgery. Method of measurement: Incidence pf complication be mentioned.;Surgical complication. Timepoint: During surgery. Method of measurement: Incidence pf complication be mentioned.;Duration of operation. Timepoint: At the time of surgery. Method of measurement: From inserting first trocar to skin suturing, by minute.;Hemodynamic changes during surgery. Timepoint: During surgery. Method of measurement: Mean of vital sign recorded by Anesthesiologist; mm Hg(blood pressure) puls rate per minute( heat rate), centigrade( temperature).;Administration of another uterotonic agent. Timepoint: During surgery. Method of measurement: Number of injection.;Post operative fever. Timepoint: From transfer of patient to ward till discharge time. Method of measurement: Record of temp. above 37.8 centigrade during hospitalization.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParnian Kord Jamshidi

Shiraz university of medical since

parnian_kurd@yahoo.com+98 71 3227 9716

Outcome results

None listed

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