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CompletedNCT02709564SL-MISOUpdated May 7, 2020

Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

A Phase 3 interventional study of Misoprostol 400 sublingual and placebo 400 sublingual in Blood Loss in Myomectomy, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Assiut University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Blood Loss in Myomectomy

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

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Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    Group A

    400 mg placebo

    Drug: placebo 400 sublingual

  • Active comparator
    Group B

    400 microgram misoprostol

    Drug: Misoprostol 400 sublingual

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

06

What researchers measure

Primary outcomes

  1. Mean amount of intraoperative blood loss

    Time frame: intraoperative

Secondary outcomes

  1. Change of hemoglobin after surgery

    Time frame: 24 hours

07

Study locations

1 site
  • Ahmed Abbas
    Assiut, Cairo 002, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02709564
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Abbas (Dr, Assiut University) — Principal investigator
First posted
Mar 16, 2016
Start date
Dec 2016
Primary completion
Dec 2019
Completion
Feb 2020
Last update
May 7, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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