Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02709564

Acronym

SL-MISO

Enrollment

Registered

2016-03-16

Start date

2016-12-31

Completion date

2020-02-29

Last updated

2020-05-07

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

Conditions

Blood Loss in Myomectomy

Brief summary

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

Interventions

DRUGMisoprostol 400 sublingual

patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery

DRUGplacebo 400 sublingual

patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
Mean amount of intraoperative blood loss	intraoperative

Secondary

Measure	Time frame
Change of hemoglobin after surgery	24 hours

Countries

Egypt

Outcome results

None listed

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