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Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by aliaa mohamed ali, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643186
First Posted: December 31, 2015
Last Update Posted: December 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
aliaa mohamed ali, Ain Shams Maternity Hospital
  Purpose
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.

Condition Intervention Phase
Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy Drug: preoperative vaginal misoprostol Procedure: bilateral uterine artery ligation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail

Resource links provided by NLM:


Further study details as provided by aliaa mohamed ali, Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • estimated intraoperative blood loss measured in milliliters [ Time Frame: 60 min ]

Secondary Outcome Measures:
  • the need of intra-operative blood transfusion [ Time Frame: 60 min ]
    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 [ Time Frame: 60 min ]
    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 [ Time Frame: 60 min ]
  • intraoperative or postoperative complications [ Time Frame: 24 hours ]
  • differance between pre and post operative hemoglobin and hematocrit levels [ Time Frame: 24 hours ]
  • duration of hospital stay in days [ Time Frame: 7 days ]

Estimated Enrollment: 62
Study Start Date: July 2015
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: misoprostol group
preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy
Drug: preoperative vaginal misoprostol
preoperative vaginal misoprostol 400 micrograms 1 hour before surgery
Other Name: cytotec
Active Comparator: uterine artery ligation group
bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy
Procedure: bilateral uterine artery ligation
bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures
Other Name: devascularization

  Eligibility

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643186


Contacts
Contact: walid basuony basuony, lecturer 01001763042 walidbasuony@gmail.com

Locations
Egypt
Ain Shams University Recruiting
Cairo, Egypt
Contact: walid basuony, lecturer    0100763042    walidbasuony@gmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital
  More Information

Responsible Party: aliaa mohamed ali, university, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02643186     History of Changes
Other Study ID Numbers: ASUMH
First Submitted: December 21, 2015
First Posted: December 31, 2015
Last Update Posted: December 31, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics