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Methods to Reduce Blood Loss in Abdominal Myomectomy

NCT04595812 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-10-22

No results posted yet for this study

Summary

The aim of the study is to compare the effectiveness of a single preoperative dose of vaginal misoprostol, intraoperative oxytocin infusion, IV carbetocin and pericervical tourniquet for the reduction of blood loss during of abdominal myomectomy.

Conditions

  • Abdominal Myomectomy
  • Blood Loss

Interventions

DRUG

Misoprostol 200mcg Tab vaginal

2 tablets vaginally 1 hour before surgery

DRUG

Oxytocin

30 IU oxytocin in 500 ml normal saline at a rate of 120 ml/h

DRUG

Carbetocin

100 μg IV Carbetocin (1ml) in 5 ml saline over 1 minute

PROCEDURE

pericervical hemostatic tourniquet

a Foley catheter size 18, which will be firmly tied at the level of the cervico-isthmic junction of the uterus before the uterine incision,The time of tourniquet administration will be recorded, and will be released not later than 45 minutes after its application. For those requiring multiple applications, the tourniquet will be reapplied after a period of at least 15 minutes.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Ibrahim Aref, professor · Kasr Alainy Cairo University

  • Soumaya Mohamed AbouElew, professor · Kasr Alainy Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-08-31
Completion
2022-09-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595812 on ClinicalTrials.gov