Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Phase 3

• Conditions: Blood Loss
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT02265562
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-15
• Last Update Submitted: 2014-10-15
• Study First Posted: 2014-10-16
• Last Update Posted: 2014-10-16
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	60 minutes before the surgery 2 tablets of placebo tablets inserted rectally
Misoprostol	Misoprostol	60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally

Primary Outcome Measures

Name	Time	Method
Blood loss	8 months	amount of intra-operative blood loss

Secondary Outcome Measures

Name	Time	Method
postoperative hemoglobin level	8 months	level of serum hemoglobin postoperatively

Trial Locations

Locations (1)

Cairo University hospiatl; 🇪🇬 Cairo, Egypt