Back to resultsVaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Primary Purpose
Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
preoperative vaginal misoprostol
bilateral uterine artery ligation
Sponsored by
About this trial
This is an interventional prevention trial for Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Eligibility Criteria
Inclusion Criteria:
- women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
- abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
- pain (dull aching lower abdominal pain or dysmenorrhea)
- pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
- progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
- maximum diameter of the largest fibroid is greater than 4 cm
- maximum number of uterine myomas is not to be more than 5 myomas
- uterine fibroid may be subserous or intramural
Exclusion Criteria:
- obesity (BMI >30 kg/m2)
- cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
- patients known to be allergic to prostaglandin preparations
- patients who received preoperative hormonal therapy (GnRH analogue)
- patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
- patients with positive pregnancy test
- virgin patients
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
misoprostol group
uterine artery ligation group
Arm Description
preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy
bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy
Outcomes
Primary Outcome Measures
estimated intraoperative blood loss measured in milliliters
Secondary Outcome Measures
the need of intra-operative blood transfusion
Below a hemoglobin concentration of 7 g/dL requiring blood transfusion. It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10).
the need for conversion from myomectomy to hysterectomy
It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids
operative time in minutes
intraoperative or postoperative complications
differance between pre and post operative hemoglobin and hematocrit levels
duration of hospital stay in days
Full Information
NCT ID
NCT02643186
First Posted
December 21, 2015
Last Updated
December 29, 2015
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02643186
Brief Title
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
Official Title
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
misoprostol group
Arm Type
Active Comparator
Arm Description
preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy
Arm Title
uterine artery ligation group
Arm Type
Active Comparator
Arm Description
bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy
Intervention Type
Drug
Intervention Name(s)
preoperative vaginal misoprostol
Other Intervention Name(s)
cytotec
Intervention Description
preoperative vaginal misoprostol 400 micrograms 1 hour before surgery
Intervention Type
Procedure
Intervention Name(s)
bilateral uterine artery ligation
Other Intervention Name(s)
devascularization
Intervention Description
bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures
Primary Outcome Measure Information:
Title
estimated intraoperative blood loss measured in milliliters
Time Frame
60 min
Secondary Outcome Measure Information:
Title
the need of intra-operative blood transfusion
Description
Below a hemoglobin concentration of 7 g/dL requiring blood transfusion. It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10).
Time Frame
60 min
Title
the need for conversion from myomectomy to hysterectomy
Description
It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids
Time Frame
60 min
Title
operative time in minutes
Time Frame
60 min
Title
intraoperative or postoperative complications
Time Frame
24 hours
Title
differance between pre and post operative hemoglobin and hematocrit levels
Time Frame
24 hours
Title
duration of hospital stay in days
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs:
abnormal uterine bleeding (menorrhagia or/and metrorrhagia)
pain (dull aching lower abdominal pain or dysmenorrhea)
pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache)
progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
maximum diameter of the largest fibroid is greater than 4 cm
maximum number of uterine myomas is not to be more than 5 myomas
uterine fibroid may be subserous or intramural
Exclusion Criteria:
obesity (BMI >30 kg/m2)
cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
patients known to be allergic to prostaglandin preparations
patients who received preoperative hormonal therapy (GnRH analogue)
patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia
patients with positive pregnancy test
virgin patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
walid basuony basuony, lecturer
Phone
01001763042
Email
walidbasuony@gmail.com
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
walid basuony, lecturer
Phone
0100763042
Email
walidbasuony@gmail.com
12. IPD Sharing Statement
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Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
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