Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05761418

Enrollment

Registered

2023-03-09

Start date

2018-03-01

Completion date

2023-02-20

Last updated

2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myoma;Uterus

Keywords

Uterine leiomyoma, misoprostol, dinoprostone

Brief summary

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

Detailed description

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

Interventions

DRUGDinoprostone

prostaglandin (PG) E2 analog

DRUGMisoprostol

prostaglandin (PG) E1 analog

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood loss	all time of the myomectomy operation	quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.

Secondary

Measure	Time frame	Description
change hemoglobin levels	within 1 week before operation and 24 hours after operation	Pre and Postoperative hemoglobin levels

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026