Back to resultsRectal Misoprostol and Blood Loss During Abdominal Hysterectomy
Primary Purpose
Blood Loss
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss focused on measuring Hysterectomy, Misoprostol, Blood loss
Eligibility Criteria
Inclusion Criteria:
A- Age: adult female >18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.
Exclusion Criteria:
A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease.
B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins.
F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.
Sites / Locations
- Cairo University hospiatlRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Misoprostol
Placebo
Arm Description
60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
60 minutes before the surgery 2 tablets of placebo tablets inserted rectally
Outcomes
Primary Outcome Measures
Blood loss
amount of intra-operative blood loss
Secondary Outcome Measures
postoperative hemoglobin level
level of serum hemoglobin postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02265562
Brief Title
Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
Official Title
Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.
Detailed Description
In this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Hysterectomy, Misoprostol, Blood loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol
Arm Type
Experimental
Arm Description
60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
60 minutes before the surgery 2 tablets of placebo tablets inserted rectally
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
prostaglandin E1 analogue
Intervention Description
60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dizirest B6
Intervention Description
60 minutes before the surgery 2 tablet of placebo inserted rectally
Primary Outcome Measure Information:
Title
Blood loss
Description
amount of intra-operative blood loss
Time Frame
8 months
Secondary Outcome Measure Information:
Title
postoperative hemoglobin level
Description
level of serum hemoglobin postoperatively
Time Frame
8 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A- Age: adult female >18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.
Exclusion Criteria:
A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease.
B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins.
F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed EL-khayat, M.D.
Phone
01005135542
Ext
+2
Email
waleed_elkhyat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-khyatat, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University hospiatl
City
Cairo
ZIP/Postal Code
12311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waleed El-khayat, M.D.
Phone
01005135542
Ext
002
Email
waleed_elkhyat@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
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