The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03820206

Collaborator

(none)

160

Enrollment

Location

Arms

Actual Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed.According to group assignment, either 1 g(10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h)

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Bleeding	Drug: Tranexamic Acid Procedure: Cesarean section	N/A

Detailed Description

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed, including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests. Maternal body weight and vital signs (heart rate, blood pressure, and respiratory rate) will be checked 30 minutes before surgery. According to group assignment, either 1 g(10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland), 1 mL(0.2 mg) intramuscular ergometrine (Methergin, Novartis, Basel, Switzerland), and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h).

Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 24 hours after delivery. On discharge, patients who received tranexamic acid will be given a brief orientation regarding symptoms and signs of a thromboembolic event and will be instructed to contact the investigators immediately if any occurred.

All patients will be examined for thromboembolic events at the 1- and 4-week follow-up visits

EBL will be calculated according to the formula:

EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85). For a two-tailed test at an α level of 0.05, the difference between the two groups regarding the primary outcome measure (EBL) had a power of 1.0 (100%) in a post hoc calculation.

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women: A Randomized Controlled Trial

Actual Study Start Date :

Jan 31, 2019

Actual Primary Completion Date :

Nov 15, 2019

Actual Study Completion Date :

Jan 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tranexamic acid group 1 g (10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.	Drug: Tranexamic Acid 1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period. Other Names: Kapron Procedure: Cesarean section Lower segement transverse cesarean section Other Names: Lower segment elective cesarean section
Placebo Comparator: Control group 30 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.	Procedure: Cesarean section Lower segement transverse cesarean section Other Names: Lower segment elective cesarean section

Arm

Intervention/Treatment

Active Comparator: Tranexamic acid group

1 g (10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Drug: Tranexamic Acid

1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Other Names:

Kapron

Procedure: Cesarean section

Lower segement transverse cesarean section

Other Names:

Lower segment elective cesarean section

Placebo Comparator: Control group

30 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Procedure: Cesarean section

Lower segement transverse cesarean section

Other Names:

Lower segment elective cesarean section

Outcome Measures

Primary Outcome Measures

Estimated blood loss (EBL) during cesarean delivery [during the operation]
EBL will be calculated according to the formula: EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

• Grand multipara
Multiple pregnancy
Polyhydraminos (AFI is more than 24 cm).
Placenta previa
Gestational diabetes mellitus
Preeclampsia
Anemia complicating pregnancy (Hemoglobin is less than 11 gm/dl)

Exclusion Criteria:

• Allergy to tranxemic acid.
H/o suggestive of bleeding disorders
previous history of deep vein thrombosis
Abnormally invasive placenta
Emergency cesarean sections
Intraoprative complications during cesarean sections as uterine artery injury and broad ligamentary hematoma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12151

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ahmed Maged, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed M Maged, MD, Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT03820206

Other Study ID Numbers:

First Posted:

Jan 29, 2019

Last Update Posted:

Jan 6, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Blood Loss, Surgical

Tranexamic Acid

Study Results

No Results Posted as of Jan 6, 2020