Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Cairo University220 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

220

Conditions

Blood Loss

Interventions

MisoprostolDRUG

60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally

PlaceboDRUG

60 minutes before the surgery 2 tablet of placebo inserted rectally

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University hospiatl

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Blood loss

amount of intra-operative blood loss

Time frame: 8 months

Secondary Outcomes

postoperative hemoglobin level

level of serum hemoglobin postoperatively

Time frame: 8 months

Central Contacts

Waleed EL-khayat, M.D.

CONTACT

01005135542 waleed_elkhyat@yahoo.com

Data from ClinicalTrials.gov

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