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Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy

NCT ID: NCT05108597

Last Updated: 2021-11-05

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2020-03-04

Brief Summary

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A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups.

100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered.

Detailed Description

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After getting approval from hospital's ethical committee, patients eligible for the study were recruited in the study according to the selection criteria. Before surgery, after taking informed written consent, patient's detailed history including demographics, parity \& BMI was recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing myomectomy were randomly divided into 2 groups using lottery method. In experimental group Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug was administered.

The surgical procedural elements, the surgeon or surgeons performing the procedure and the use of antibiotics as well as anesthetic agents was standardized to remove any bias. Intraoperative blood loss was recorded by a single trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.

Conditions

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Blood Loss, Surgical Uterine Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
There will be a single trained person who calculated the intra-operative blood loss and was blinded to the randomization of the patients and the use of medication.

Study Groups

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Misoprostol (Study Group)

In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy

No drug

In control group no dose will be administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Misoprostol

400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy

Intervention Type DRUG

Other Intervention Names

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Prosotec

Eligibility Criteria

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Inclusion Criteria

1. ASA physical status class I-II
2. Intramural or subserosal fibroids - diagnosed on ultrasound
3. Candidates for elective abdominal myomectomy

Exclusion Criteria

1. Pre-operative Hemoglobin \< 10 g/dl
2. Patient who received Danazol or GnRH analogues before surgery
3. No other systemic or metabolic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pak Emirates Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Salma Nisar

Resident OBGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salma Nisar

Role: PRINCIPAL_INVESTIGATOR

Resident OBGYN

Locations

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PEMH

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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25102021

Identifier Type: -

Identifier Source: org_study_id