Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Misoprostol

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

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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

Placebo

60 minutes before the surgery 2 tablets of placebo tablets inserted rectally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

60 minutes before the surgery 2 tablet of placebo inserted rectally

Interventions

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Misoprostol

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

Intervention Type DRUG

Placebo

60 minutes before the surgery 2 tablet of placebo inserted rectally

Intervention Type DRUG

Other Intervention Names

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prostaglandin E1 analogue Dizirest B6

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes