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

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 .

Study Overview

• Status: Unknown
• Conditions: Blood Loss; Myoma;Uterus
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebos

Detailed Description

. Type of Study : Prospective double blind randomized placebo controlled clinical trial.

• Study Setting : This study will be conducted in Ain Shams University Maternity hospital.
• Study Period : 6 months
• Study Population : Patients will be recruited in this study those attending gynecology ward at Ain Shams University Maternity hospital who are 25-50 years old with symptomatic uterine myoma

Methodology

All women will be subjected to:

History taking:

It includes name, age, occupation, marriage and special habits,last menstrual period, menstrual history, history of present illness ( symptoms related to myoma ), any medical disorders and any previous surgeries.

Examination

General examination:

It includes blood pressure, heart rate and body temperature, body mass index, head& neck examination Bilateral lower limb examination.

Abdominal examination:

It includes:

1. Inspection : pelvi-abdominal swelling
2. Palpation : smooth or irregular surface - mobility - consistency - size - tenderness
3. Auscultation : soufflé ( increased vascularity )
4. Percussion : dullness

Local examination:

Vaginal examnation will be done to detect uterine swelling with transmitted movement to the cervix . if movement not transmitted to cervix , it revealed extra-uterine swelling , also examination of adnexa Investigations Ultrasonography ( abdominal / vaginal ), (hysteroscopy , MRI , D&C if indicated ) Pre-operative investigation ( Complete blood picture, blood group , RH, hematocrite , Kidney Function Test , Liver Function Test , random Blood Sugar , urine analysis 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

In all operations, the abdomen is entered by a Pfannenstiel incision. The operations are performed by the same team to avoid any bias related to surgical skills. The total volume of intra-operative blood loss is estimated by measuring the amount of blood accumulated in the suction container and the amount of blood on the surgical gauze by gauze weighting, the surgical gauzes are weighted before and after surgery using a scale accurate to 1 gram and the weight difference was calculated. The weight of 1 gram is taken as 1 ml blood.

Vital data during operation and the duration of the operation are recorded (time from opening of the peritoneum until its closure). The postoperative haemoglobin level is measured for each participant 24 h after the operation. Records are kept for any intra-operative or postoperative blood transfusion. Any postoperative adverse events, including any febrile episode (increase to or over 38.5°C in body temperature within 24 h following surgery) are documented. Also post operative vital data will be recorded

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: dina yahia mansour, MD; Phone Number: +201006575414; Email: dinayahiamansour@hotmail.com
• Study Contact Backup: Name: aziza mohamed, master; Phone Number: +201157509657; Email: ahmedwza1988@gmail.com

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11566
      • Recruiting
      • Ain Shams Maternity Hospital
      • Contact: abd el fatah soaod, professor; Phone Number: +226834576; Email: Viced.research@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: misoprostol group; misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation	Drug: Misoprostol; ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation; Other Names: misotac
PLACEBO_COMPARATOR: placebo group; ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.	Drug: Placebos; ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	reduce intra operative blood loss during myomectomy	time of operation

Collaborators and Investigators

• Sponsor: ahmed nagy shaker ramadan
• Investigators: Principal Investigator: sabry sayed, professor, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ANTICIPATED): July 30, 2018
• Study Completion (ANTICIPATED): July 30, 2018

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (ACTUAL): March 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Hemorrhage; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: Myomectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes