Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy Clinical Trial
Official title:
Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail
| NCT number | NCT02643186 |
| Other study ID # | ASUMH |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 4 |
| First received | December 21, 2015 |
| Last updated | December 29, 2015 |
| Start date | July 2015 |
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.
| Status | Recruiting |
| Enrollment | 62 |
| Est. completion date | |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ain Shams University | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams Maternity Hospital |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | estimated intraoperative blood loss measured in milliliters | 60 min | Yes | |
| Secondary | 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). | 60 min | Yes |
| Secondary | 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 | 60 min | Yes |
| Secondary | operative time in minutes | 60 min | Yes | |
| Secondary | intraoperative or postoperative complications | 24 hours | Yes | |
| Secondary | differance between pre and post operative hemoglobin and hematocrit levels | 24 hours | Yes | |
| Secondary | duration of hospital stay in days | 7 days | Yes |