Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Zagazig University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Submucous Leiomyoma of Uterus

Treatments: Drug: Vasopressin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03930069

Hysterscopioc myomectomy

Details and patient eligibility

About

A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .

Full description

This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
• grade 0 and grade 1 submucous myomas
• less than 5 centimeters in diameter

Exclusion criteria

• Patients with grade 2 submucous myoma or more
• patients with submucous myomas larger than 5 cm in diameter
• postmenopausal women
• patients received GnRh analogue in last 6 months
• patients with anticoagulant therapy
• patients with endometrial premalignant or malignant pathologies
• patients with cardiovascular diseases, asthma or impaired kidney functions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

misoprostol group

Active Comparator group

Description:

20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.

Treatment:

Drug: Misoprostol

vasopressin group

Active Comparator group

Description:

20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy

Treatment:

Drug: Vasopressin