This randomized Double-blind clinical trial study will be conducted after approval from the ethics committee of Mashhad University of Medical Sciences durnig 2016 to 2017. Study group consists of 100 women who will be undergoing abdominal hysterectomy with or without removal of the ovaries due to uterine myoma and meets inclusion criteria. They will be randomly divided in to two groups (study and control groups). Study and control group will Receive a misoprostol pack (400µg) or a pack of Placebo before operation, respectively. The placebo pack is completely similar to misoprostol and will be prepared by pharmacologist and applied sublingually for the patient half hours before operation. Random allocation is done by methodologist, and results of the project will be sealed in envelopes. No one knows about the allocation for the confidentiality of the patients data. Gravimetric methods (The gravity of bloody sponges, The amount of blood inside the suction device) will be used to estimate the amount of bleeding during surgery and The hemoglobin level will be measured 24 hours after surgery.
General information
Acronym
TAH
IRCT registration information
IRCT registration number:IRCT2016122831635N1
Registration date:2017-06-09, 1396/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Salme Dadgar
Name of organization / entity
Mashhad university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
dadgars@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences.
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a single dose of sublingual misoprostol on blood loss in total abdominal hysterectomy in patients with uterine myoma
Public title
The effect of a single dose of sublingual misoprostol on blood loss in total abdominal hysterectomy in patients with uterine myoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who choose to be treated by TAH with BSO or without BSO; Their last delivery was 24 months ago or before.
Exclusion criteria: History of pelvic surgery; Severe heart or lung disease; Hematologic Disorders; Glaucoma; Asthma; liver disease; Endometriosis; Adnexal masses; history of myomectomy; Those who have taken GnRH agonist before surgery; allergy to misoprostol, Diastolic pressure above 100.