Clinical trial NCT04201951: Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women
Official title: Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
High Risk Pregnancy
Tranexamic Acid
Third-Stage Postpartum Hemorrhage, With Delivery
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
Primary purpose: PREVENTION

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)
timeFrame: From the time of injection and up to 2 hours after delivery
Secondary outcomes:
measure: Number of participant with Post Partum Hemorrhage
timeFrame: up to 2 hours after delivery
measure: Number of participant with severe postpartum hemorrhage
timeFrame: up to 2 hours after delivery
measure: Number of participant who will need additional uterotonic drugs to control blood loss
timeFrame: up to 2 hours after delivery
measure: the mean length of third stage of labor in both groups
timeFrame: up to 30 minutes
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Kurdistan Board for Medical speciality
state: Kurdistan Region
city: Erbil
country: Iraq
facility: Maternity Teaching Hospital
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: Shahla K. Alalaf, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministery of Health
name: Sazgar A. Rashid, FIBOG
role: STUDY_CHAIR
affiliation: Kurdistan Board for Medical Speciality
name: Chro S. Hassan, MBChB
role: STUDY_CHAIR
References: