Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-02-20

Brief Summary

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Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

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Detailed Description

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Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital

Conditions

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Myoma;Uterus

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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Dinoprostone

Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.

Group Type EXPERIMENTAL

Dinoprostone

Intervention Type DRUG

prostaglandin (PG) E2 analog

Misoprostol

will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

prostaglandin (PG) E1 analog

control

received a placebo vaginally 2 hrs. preoperatively.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dinoprostone

prostaglandin (PG) E2 analog

Intervention Type DRUG

Misoprostol

prostaglandin (PG) E1 analog

Intervention Type DRUG

Other Intervention Names

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Dinoglandin Cytotec

Eligibility Criteria

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Inclusion Criteria

* Age 30-50 years
* all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.

Exclusion Criteria

* contraindications to dinoprostone or misoprostol,
* active PID,
* history of pelvic/ ovarian endometriosis,
* females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes