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

NCT ID: NCT02643186

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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misoprostol group

preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy

Group Type ACTIVE_COMPARATOR

preoperative vaginal misoprostol

Intervention Type DRUG

preoperative vaginal misoprostol 400 micrograms 1 hour before surgery

uterine artery ligation group

bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy

Group Type ACTIVE_COMPARATOR

bilateral uterine artery ligation

Intervention Type PROCEDURE

bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures

Interventions

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preoperative vaginal misoprostol

preoperative vaginal misoprostol 400 micrograms 1 hour before surgery

Intervention Type DRUG

bilateral uterine artery ligation

bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures

Intervention Type PROCEDURE

Other Intervention Names

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cytotec devascularization

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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aliaa mohamed ali

university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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walid basuony basuony, lecturer

Role: CONTACT

Phone: 01001763042

Email: [email protected]

Facility Contacts

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walid basuony, lecturer

Role: primary

Other Identifiers

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ASUMH

Identifier Type: -

Identifier Source: org_study_id