Clinical Trials Directory

Trials / Terminated

TerminatedNCT02209545

Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Northwestern University · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.

Detailed description

This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.

Conditions

Interventions

TypeNameDescription
DRUGMisoprostol25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
DRUGPlacebo25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.

Timeline

Start date
2014-10-01
Primary completion
2022-07-01
Completion
2022-07-01
First posted
2014-08-06
Last updated
2023-09-07
Results posted
2023-09-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02209545. Inclusion in this directory is not an endorsement.