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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02265562
Other study ID # 10102014
Secondary ID
Status Recruiting
Phase Phase 3
First received October 10, 2014
Last updated October 15, 2014
Start date October 2014
Est. completion date June 2015

Study information

Verified date October 2014
Source Cairo University
Contact Waleed EL-khayat, M.D.
Phone 01005135542
Email waleed_elkhyat@yahoo.com
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.


Description:

In this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

A- Age: adult female >18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.

Exclusion Criteria:

A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease.

B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins.

F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol
60 minutes before the surgery 400 µg of misoprostol (2 tablets of 200 µg) inserted rectally
Placebo
60 minutes before the surgery 2 tablet of placebo inserted rectally

Locations

Country Name City State
Egypt Cairo University hospiatl Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss amount of intra-operative blood loss 8 months Yes
Secondary postoperative hemoglobin level level of serum hemoglobin postoperatively 8 months Yes
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