the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation

NCT03483142 | Unknown Phase 3

• 1 other identifier: Myomectomy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .

Conditions

Myoma;Uterus; Blood Loss

Outcome Measures

Primary Outcomes (1)

• blood loss

  reduce intra operative blood loss during myomectomy

  time of operation

Study Arms (2)

misoprostol group

EXPERIMENTAL

misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation

Drug: Misoprostol

placebo group

PLACEBO COMPARATOR

( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.

Drug: Placebos

Interventions

Misoprostol DRUG

( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation

Also known as: misotac

misoprostol group

Placebos DRUG

( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol

placebo group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal patients aged between 35 to 50 years old.
• Five or less symptomatic uterine myomas .
• Maximum diameter of the largest myoma is 6 cm .
• All myomas are subserous or intramural.
• Uterine size less than 24 weeks pregnancy

You may not qualify if:

• History of previous surgery.
• Allergy to Misoprostol.
• Hypertension.
• Cardiac and Pulmonary diseases.
• Patients who have bleeding disorders.
• Anemia (Hb \< 10g %).
• Chronic endocrine or metabolic diseases such as Diabetes.
• Obesity (body mass index \> 30 kg/m2).
• Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Sponsors & Collaborators

• ahmed nagy shaker ramadan: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Abbasia, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Myofibroma; Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• sabry sayed, professor

  Ain Shams Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dina yahia mansour, MD

CONTACT

+201006575414; dinayahiamansour@hotmail.com

aziza mohamed, master

CONTACT

+201157509657; ahmedwza1988@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident of obstetric and gynecology

Model Details: Intervention All women will be randomly assigned to either: Group A ( study group ) ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol. Group B (control group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 30, 2018
• Study Start: November 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

EG (1)