Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy

NCT ID: NCT02716142

Last Updated: 2020-05-20

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bleeding During Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

rectal misoprostol 400 microgram

Group Type EXPERIMENTAL

rectal misoprostol

Intervention Type DRUG

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

Group B

sublingual misoprostol 400 microgram

Group Type ACTIVE_COMPARATOR

sublingual misoprostol

Intervention Type DRUG

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

Interventions

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rectal misoprostol

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

Intervention Type DRUG

sublingual misoprostol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MISOP

Identifier Type: -

Identifier Source: org_study_id

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