Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483142
Recruitment Status : Unknown
Verified May 2018 by ahmed nagy shaker ramadan, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
ahmed nagy shaker ramadan, Ain Shams Maternity Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE March 30, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
blood loss [ Time Frame: time of operation ]
reduce intra operative blood loss during myomectomy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
Official Title  ICMJE the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Myoma;Uterus
  • Blood Loss
Intervention  ICMJE
  • Drug: Misoprostol
    ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
    Other Name: misotac
  • Drug: Placebos
    ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol
Study Arms  ICMJE
  • Experimental: misoprostol group
    misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
    Intervention: Drug: Misoprostol
  • Placebo Comparator: placebo group
    ( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2018
Estimated Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03483142
Other Study ID Numbers  ICMJE Myomectomy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ahmed nagy shaker ramadan, Ain Shams Maternity Hospital
Study Sponsor  ICMJE ahmed nagy shaker ramadan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: sabry sayed, professor Ain Shams Maternity Hospital
PRS Account Ain Shams Maternity Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP