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

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 4

Conditions: Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

Treatments: Procedure: bilateral uterine artery ligation; Drug: preoperative vaginal misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02643186

ASUMH

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

misoprostol group

Active Comparator group

Description:

preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy

Treatment:

Drug: preoperative vaginal misoprostol

uterine artery ligation group

Active Comparator group

Description:

bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy

Treatment:

Procedure: bilateral uterine artery ligation