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

NCT ID: NCT03483142

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-07-30

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 .

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

Conditions

Myoma;Uterus; Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

misoprostol group

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

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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

placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

Misoprostol

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

misotac

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ahmed nagy shaker ramadan

OTHER

Sponsor Role: lead

Responsible Party

ahmed nagy shaker ramadan

resident of obstetric and gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

sabry sayed, professor

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital

Locations

Ain Shams Maternity Hospital

Cairo, Abbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

dina yahia mansour, MD

Role: CONTACT

dinayahiamansour@hotmail.com

+201006575414

aziza mohamed, master

Role: CONTACT

ahmedwza1988@gmail.com

+201157509657

Facility Contacts

abd el fatah soaod, professor

Role: primary

Viced.research@med.asu.edu.eg

+226834576

Other Identifiers

Myomectomy

Identifier Type: -

Identifier Source: org_study_id