Symptomatic uterine fibroid
Conditions
Interventions
One gram of intravenous tranexamic acid given to the experimental group one hour before surgery
The use of intravenous placebo to reduce blood loss during open abdominal myomectomy.
Sponsors
John Inya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Age: 18-49 years • Patients who consent to study • Symptomatic uterine fibroid • Patients scheduled for open abdominal myomectomy with myoma stage 3 to 6 according to FIGO staging • At least one uterine fibroid nodule greater than or equal to 4 cm • At least 3 total uterine fibroids based on preoperative imaging
Exclusion criteria
Exclusion criteria: • Patients who do not consent to study • Patients undergoing laparoscopic myomectomy • Pregnancy • Virgo intacta • Medical Co-morbidities (e.g. Renal failure, heart failure) • Coagulopathies • Known allergies to tranexamic acid • Genital tract Malignancy • Use of GNRH analogue • Previous myomectomy • Previous exploratory laparotomy • Patients with cervical fibroids • Patients with broad ligaments fibroid • Patients with myoma stage 0,1 and 2 according to FIGO staging • Severe anaemia Hb < 7gm/dl. • Mentally disabled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Intraoperative blood loss during open abdominal myomectomy •Post-operative blood loss during open abdominal myomectomy •Total blood loss during open abdominal myomectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| • Haemoglobin change (g/dl) • Need for Blood transfusion (%) • Need for additional Surgical Intervention • Duration of surgery (minutes) • Adverse effects of tranexamic acid (%) • Post-operative hospital stay (post-surgical complications e.g. may be due to due to post-operative infection, fever). | — |
Countries
Nigeria
Contacts
Public ContactJohn Inya
Researcher
Outcome results
None listed