Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Beni-Suef University

Status and phase: Completed; Phase 3

Conditions: Myoma;Uterus

Treatments: Drug: Dinoprostone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05761418

REC-H-PhBSU-22021

Details and patient eligibility

About

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

Full 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

Enrollment: 90 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups

Dinoprostone

Experimental group

Description:

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

Treatment:

Drug: Dinoprostone

Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

control

No Intervention group

Description:

received a placebo vaginally 2 hrs. preoperatively.