Skip to content

Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy

Rectal Misoprostol Versus Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02716142
Acronym
RM-SLM
Enrollment
80
Registered
2016-03-23
Start date
2017-03-01
Completion date
2020-04-30
Last updated
2020-05-20

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

Conditions

Bleeding During Myomectomy

Brief summary

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.

Interventions

patients will take 2 tablets of rectally misoprostol 400 microgram 60 minutes before the procedure

patients will take 2 tablets of sublingual misoprostol 400 microgram 60 minutes before the procedure

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mean amount of blood lossintraoperative

Secondary

MeasureTime frame
Change of hemoglobin level24 hours

Countries

Egypt

Outcome results

None listed

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