Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Blood Loss Clinical Trial

Official title:

Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02265562
• Other study ID #: 10102014
• 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

• Blood Loss
• Hemorrhage

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