Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy

NCT02716142 | Completed Phase 4 DMC

• 1 other identifier: MISOP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of the study is To compare the effectiveness of rectally administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before myomectomy to decrease blood loss during and after the operation.

Conditions

Bleeding During Myomectomy

Outcome Measures

Primary Outcomes (1)

• Mean amount of blood loss

  intraoperative

Secondary Outcomes (1)

• Change of hemoglobin level

  24 hours

Study Arms (2)

Group A

EXPERIMENTAL

rectal misoprostol 400 microgram

Drug: rectal misoprostol

Group B

ACTIVE COMPARATOR

sublingual misoprostol 400 microgram

Drug: sublingual misoprostol

Interventions

rectal misoprostol DRUG

patients will take 2 tablets of rectally misoprostol 400 microgram 60 minutes before the procedure

Group A

sublingual misoprostol DRUG

patients will take 2 tablets of sublingual misoprostol 400 microgram 60 minutes before the procedure

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
• Age ≥ 18 years and ≤ 50 years
• Pre-operative hemoglobin \>8 g/dl
• Ability to understand and the willingness to sign a written informed consent.
• Admissible medical/surgical history
• Five or less symptomatic uterine myomas
• All myomas are subserous or intramural.
• Uterine size less than 24 weeks pregnancy

You may not qualify if:

• Patients who have had a prior abdominal myomectomy
• Post-menopausal women
• Patients with known bleeding/clotting disorders
• Patients with a history of gynecologic malignancy
• Hypertension.
• Cardiac and Pulmonary diseases.
• Obesity (body mass index \> 30 kg/m2).
• History of allergic reactions attributed to misoprostol
• Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

EG (1)