Skip to content

Randomized controlled trial on the effect of intravenous Tranexamic acid versus sublingual Misoprostol on blood loss during abdominal myomectomy..

Randomized controlled trial on the effect of intravenous Tranexamic acid versus sublingual misoprostol on blood loss during abdominal myomectomy..

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202502529024955
Enrollment
70
Registered
2025-02-14
Start date
2025-01-07
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Circulatory System Surgery uterine fibroid

Interventions

Group 1 intravenous tranexamic acid group
GROUP II sublingual misoprostol group

Sponsors

Esan Babatunde Ayodeji
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with uterine fibroid who agree to participate in this study and schedule for primary abdominal myomectomy

Exclusion criteria

Exclusion criteria: (1) Women with previous uterine surgery (previous myomectomy, caesarean delivery). (2) Pregnant women. (3) Women who have allergy or hypersensitivity to Tranexamic acid. (4) Women with severe endometriosis, malignancy or chronic medical disorders like hypertension, cardiac and pulmonary diseases, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30kg/m2). (6) Patients with bleeding disorder (7) Patient who refused to partake in the study (8) Patient who has received preoperative hormonal therapy (such as GnRH analogue or oral contraceptives pills) that could affect the intra operative bleeding and the duration of operation. (9) Patients for laparoscopic or hysteroscopic myomectomy (10) Women who had contraindications or allergy to misoprostol based on questions including the experience of skin eruptions, urticaria, rash, shortness of breath, cough, chest pain in prior misoprostol administrations.

Design outcomes

Primary

MeasureTime frame
Estimation of total blood loss at surgery;Estimation of total blood loss at surgery- Visual and gravimetric method of estimating blood loss will be used to estimate the blood loss during the surgery. An electronic weighing machine that could weigh between 0.1g to 500g will be used to measure the baseline weight of the dry abdominal packs and gauze. The weight of the blood soaked abdominal pack and gauzes will be measured with an electronic weighing machine after the surgery. The difference between the weight of the dry abdominal pack and gauze from the weight of the soaked abdominal pack and gauze in gram is equivalent to the weight of the blood loss in gram. I gram difference in the weight is equal to I milliliter of blood. The total blood loss will be calculated by adding the volume of blood in the calibrated measuring jar and on the operating drapes with the equivalent milliliter of the weighed materials gotten from the gravimetric method. ;Estimation of total blood loss at surgery;estimation of total blood loss intraoperativel

Secondary

MeasureTime frame
Operation time in minute from skin incision to skin closure, operation time in minute starting from first uterine incision to closure of last uterine incision, postoperative stay in hospital in days and the need for blood transfusion either intraoperatively or postoperatively. ;Operation time in minute from skin incision to skin closure, operation time in minute starting from first uterine incision to closure of last uterine incision, postoperative stay in hospital in days and the need for blood transfusion either intraoperatively or postoperatively;Operation time in minute from skin incision to skin closure, operation time in minute starting from first uterine incision to closure of last uterine incision, postoperative stay in hospital in days and the need for blood transfusion either intraoperatively or postoperatively.;1. operation time in minute from skin incision to skin closure. 2. , operation time in minute starting from first uterine incision to closure of last uterine incision. 3.postoperative stay in hospital in days and the need for blood transfusion either intraoperatively or postoperatively

Countries

Nigeria

Contacts

Public Contactjoyce esan

nursing lecturer

yettyme03@yahoo.com+2348032318220

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026