Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy (RM-SLM)

Assiut University

Status and phase

Completed

Phase 4

Conditions

Bleeding During Myomectomy

Treatments

Drug: rectal misoprostol

Drug: sublingual misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT02716142

MISOP

Details and patient eligibility

About

the aim of the study is To compare the effectiveness of rectally administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before myomectomy to decrease blood loss during and after the operation.

Enrollment

80 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
Age ≥ 18 years and ≤ 50 years
Pre-operative hemoglobin >8 g/dl
Ability to understand and the willingness to sign a written informed consent.
Admissible medical/surgical history
Five or less symptomatic uterine myomas
All myomas are subserous or intramural.
Uterine size less than 24 weeks pregnancy

Exclusion criteria

Patients who have had a prior abdominal myomectomy
Post-menopausal women
Patients with known bleeding/clotting disorders
Patients with a history of gynecologic malignancy
Hypertension.
Cardiac and Pulmonary diseases.
Obesity (body mass index > 30 kg/m2).
History of allergic reactions attributed to misoprostol
Cases that will require intraoperative conversion of myomectomy to hysterectomy.