the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
Primary Purpose
Myoma;Uterus, Blood Loss
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Placebos
Sponsored by
About this trial
This is an interventional supportive care trial for Myoma;Uterus
Eligibility Criteria
Inclusion Criteria:
- Premenopausal patients aged between 35 to 50 years old.
- Five or less symptomatic uterine myomas .
- Maximum diameter of the largest myoma is 6 cm .
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Exclusion Criteria:
- History of previous surgery.
- Allergy to Misoprostol.
- Hypertension.
- Cardiac and Pulmonary diseases.
- Patients who have bleeding disorders.
- Anemia (Hb < 10g %).
- Chronic endocrine or metabolic diseases such as Diabetes.
- Obesity (body mass index > 30 kg/m2).
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Sites / Locations
- Ain Shams Maternity HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
misoprostol group
placebo group
Arm Description
misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
Outcomes
Primary Outcome Measures
blood loss
reduce intra operative blood loss during myomectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03483142
Brief Title
the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
Official Title
the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ahmed nagy shaker ramadan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .
Detailed Description
. Type of Study : Prospective double blind randomized placebo controlled clinical trial.
Study Setting : This study will be conducted in Ain Shams University Maternity hospital.
Study Period : 6 months
Study Population : Patients will be recruited in this study those attending gynecology ward at Ain Shams University Maternity hospital who are 25-50 years old with symptomatic uterine myoma
Methodology
All women will be subjected to:
History taking:
It includes name, age, occupation, marriage and special habits,last menstrual period, menstrual history, history of present illness ( symptoms related to myoma ), any medical disorders and any previous surgeries.
Examination
General examination:
It includes blood pressure, heart rate and body temperature, body mass index, head& neck examination Bilateral lower limb examination.
Abdominal examination:
It includes:
Inspection : pelvi-abdominal swelling
Palpation : smooth or irregular surface - mobility - consistency - size - tenderness
Auscultation : soufflé ( increased vascularity )
Percussion : dullness
Local examination:
Vaginal examnation will be done to detect uterine swelling with transmitted movement to the cervix . if movement not transmitted to cervix , it revealed extra-uterine swelling , also examination of adnexa Investigations Ultrasonography ( abdominal / vaginal ), (hysteroscopy , MRI , D&C if indicated ) Pre-operative investigation ( Complete blood picture, blood group , RH, hematocrite , Kidney Function Test , Liver Function Test , random Blood Sugar , urine analysis Intervention
All women will be randomly assigned to either:
Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
In all operations, the abdomen is entered by a Pfannenstiel incision. The operations are performed by the same team to avoid any bias related to surgical skills. The total volume of intra-operative blood loss is estimated by measuring the amount of blood accumulated in the suction container and the amount of blood on the surgical gauze by gauze weighting, the surgical gauzes are weighted before and after surgery using a scale accurate to 1 gram and the weight difference was calculated. The weight of 1 gram is taken as 1 ml blood.
Vital data during operation and the duration of the operation are recorded (time from opening of the peritoneum until its closure). The postoperative haemoglobin level is measured for each participant 24 h after the operation. Records are kept for any intra-operative or postoperative blood transfusion. Any postoperative adverse events, including any febrile episode (increase to or over 38.5°C in body temperature within 24 h following surgery) are documented. Also post operative vital data will be recorded
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma;Uterus, Blood Loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Intervention
All women will be randomly assigned to either:
Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
misoprostol group
Arm Type
Experimental
Arm Description
misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
misotac
Intervention Description
( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol
Primary Outcome Measure Information:
Title
blood loss
Description
reduce intra operative blood loss during myomectomy
Time Frame
time of operation
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premenopausal patients aged between 35 to 50 years old.
Five or less symptomatic uterine myomas .
Maximum diameter of the largest myoma is 6 cm .
All myomas are subserous or intramural.
Uterine size less than 24 weeks pregnancy
Exclusion Criteria:
History of previous surgery.
Allergy to Misoprostol.
Hypertension.
Cardiac and Pulmonary diseases.
Patients who have bleeding disorders.
Anemia (Hb < 10g %).
Chronic endocrine or metabolic diseases such as Diabetes.
Obesity (body mass index > 30 kg/m2).
Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dina yahia mansour, MD
Phone
+201006575414
Email
dinayahiamansour@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
aziza mohamed, master
Phone
+201157509657
Email
ahmedwza1988@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sabry sayed, professor
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abd el fatah soaod, professor
Phone
+226834576
Email
Viced.research@med.asu.edu.eg
12. IPD Sharing Statement
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the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
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