Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women

Hawler Medical University

Status: Completed

Conditions: High Risk Pregnancy; Tranexamic Acid; Third-Stage Postpartum Hemorrhage, With Delivery; Postpartum Hemorrhage

Treatments: Other: Glucose water 5%; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04201951

HawlerMU3

Details and patient eligibility

About

Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage

Full description

Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.

A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on

Enrollment: 196 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 year.
• Planed vaginal delivery
• Grand multiparity
• Twin pregnancy
• Polyhydramnios
• Previous history of PPH
• Macrosomic baby
• Prolonged labour
• HELLP syndrome
• Using of low-molecular weight heparin and Asprin during pregnancy.
• Vaginal birth after Cesarean section

Exclusion criteria

• Intrauterine death.
• History of thromboembolic disease
• Current or previous history of heart disease ,renal and liver disorders
• History of seizure or epilepsy
• Placenta previa
• Placental abruptio

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 2 patient groups, including a placebo group

Tranexamic group

Active Comparator group

Description:

Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water

Treatment:

Other: Glucose water 5%

Drug: Tranexamic acid injection

Placebo group

Placebo Comparator group

Description:

Group B will receive 30ML 5% glucose water

Treatment:

Other: Glucose water 5%

Drug: Tranexamic acid injection