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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

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 .

Condition or disease Intervention/treatment Phase
Myoma;Uterus Blood Loss Drug: Misoprostol Drug: Placebos Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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 Name: 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




Primary Outcome Measures :
  1. blood loss [ Time Frame: time of operation ]
    reduce intra operative blood loss during myomectomy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483142


Contacts
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Contact: dina yahia mansour, MD +201006575414 dinayahiamansour@hotmail.com
Contact: aziza mohamed, master +201157509657 ahmedwza1988@gmail.com

Locations
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Egypt
Ain Shams Maternity Hospital Recruiting
Cairo, Abbasia, Egypt, 11566
Contact: abd el fatah soaod, professor    +226834576    Viced.research@med.asu.edu.eg   
Sponsors and Collaborators
ahmed nagy shaker ramadan
Investigators
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Principal Investigator: sabry sayed, professor Ain Shams Maternity Hospital
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Responsible Party: ahmed nagy shaker ramadan, resident of obstetric and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03483142    
Other Study ID Numbers: Myomectomy
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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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
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Hemorrhage
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics