Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
Primary Purpose
Obstetrical Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
transamin
Sponsored by

About this trial
This is an interventional prevention trial for Obstetrical Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- gestational age between 37 and 42 weeks,
- live fetus,
- cephalic presentation,
- vaginal birth.
- Patients who had a risk factors for PPH, such as multiple gestation, polyhydramnios, fetal macrosomia, antepartum hemorrhage, anemia (haemoglobin concentration < 8 g/dL), severe pre-eclampsia, or coagulopathy
Exclusion Criteria:
- placenta previa,
- placental abruption,
- cesarean section or any uterine scar, abnormal placentation (accreta, increta, or percreta),
- a current or previous history of significant disease, including heart disease, liver, renal disorders.
Sites / Locations
- Bakıryok Women and Children Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
tranexamic acid
saline
Arm Description
TA administered intravenously over a 5 min period at delivery of the anterior shoulder
10 mL of saline was administered intravenously over a 5 min period at delivery of the anterior shoulder
Outcomes
Primary Outcome Measures
The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor.
The volume of blood loss was measured by weighing a sheet soaked from the end of the delivery to 2h after birth. We used a specially designed operating sheet and an electronic scale to weigh all the material (with a 1 g deviation range). The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05.
Secondary Outcome Measures
incidences of PPH >500 ml
The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 > 500 mL
the incidences of severe postpartum hemorrhage
The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 ≥1000 ml
need for additional uterotonic drugs
need for additional uterotonic drugs such as 200 µg intravenous metylergometrine, 20 IU oxytocin infusion in 500 ml ringer lactate, and/or 800 misoprostol rectally for vaginal bleeding
side effects at time of TA injection
nausea, vomiting or diarrhea
Full Information
NCT ID
NCT01338454
First Posted
April 11, 2011
Last Updated
November 16, 2011
Sponsor
Erzincan Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01338454
Brief Title
Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital
4. Oversight
5. Study Description
Brief Summary
Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and was the most common cause of maternal death in the Turkey [1,2]. Most of these deaths occur within 4 h of delivery and are a result of problems during third and fourth stages of labor. It also contributes significantly to serious maternal morbidity. Obstetric, surgical and radiological interventions play central role in the management of obstetric hemorrhage; however, pharmacologic management and in particular prohemostatic therapies also play an important role in the final maternal outcome. Administration of tranexamic acid (TA), intravenously in the third stage of labor may be one of these methods.
TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding. TA may enhance the effectiveness of the patient's own hemostatic mechanism [3,4]. In nonobstetric surgery, a systematic review of randomized controlled trails showed that tranexamic acid reduced the risk of blood transfusion [ relative risk (RR) 0.61; 95% CI 0.54-0.69] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95% CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events [5].
In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and is an effective and well-tolerated treatment when administered orally [5,6,7]. Bleeding associated with pregnancy (placental abruption, placenta previa) has also been treated with TA [6]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum hemorrhage (PPH) following cesarean delivery [7-11]. Only one randomized trail is available evaluating the effect of TA use to prevent bleeding in the postpartum period following spontaneous vaginal delivery [12].
The purpose of our study was to estimate the effect of the addition of intravenous TA to a standard active management of the third stage of labor (which includes prophylactic injection of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and controlled cord traction).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetrical Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
TA administered intravenously over a 5 min period at delivery of the anterior shoulder
Arm Title
saline
Arm Type
No Intervention
Arm Description
10 mL of saline was administered intravenously over a 5 min period at delivery of the anterior shoulder
Intervention Type
Drug
Intervention Name(s)
transamin
Intervention Description
TA was administered intravenously over a 5 min period at delivery of the anterior shoulder
Primary Outcome Measure Information:
Title
The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor.
Description
The volume of blood loss was measured by weighing a sheet soaked from the end of the delivery to 2h after birth. We used a specially designed operating sheet and an electronic scale to weigh all the material (with a 1 g deviation range). The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
incidences of PPH >500 ml
Description
The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 > 500 mL
Time Frame
2 hours
Title
the incidences of severe postpartum hemorrhage
Description
The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 ≥1000 ml
Time Frame
2 hours
Title
need for additional uterotonic drugs
Description
need for additional uterotonic drugs such as 200 µg intravenous metylergometrine, 20 IU oxytocin infusion in 500 ml ringer lactate, and/or 800 misoprostol rectally for vaginal bleeding
Time Frame
2 hours
Title
side effects at time of TA injection
Description
nausea, vomiting or diarrhea
Time Frame
2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
gestational age between 37 and 42 weeks,
live fetus,
cephalic presentation,
vaginal birth.
Patients who had a risk factors for PPH, such as multiple gestation, polyhydramnios, fetal macrosomia, antepartum hemorrhage, anemia (haemoglobin concentration < 8 g/dL), severe pre-eclampsia, or coagulopathy
Exclusion Criteria:
placenta previa,
placental abruption,
cesarean section or any uterine scar, abnormal placentation (accreta, increta, or percreta),
a current or previous history of significant disease, including heart disease, liver, renal disorders.
Facility Information:
Facility Name
Bakıryok Women and Children Hospital
City
İstanbul
State/Province
Bakırkoy
ZIP/Postal Code
34142
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
23023559
Citation
Gungorduk K, Asicioglu O, Yildirim G, Ark C, Tekirdag AI, Besimoglu B. Can intravenous injection of tranexamic acid be used in routine practice with active management of the third stage of labor in vaginal delivery? A randomized controlled study. Am J Perinatol. 2013 May;30(5):407-13. doi: 10.1055/s-0032-1326986. Epub 2012 Sep 21.
Results Reference
derived
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Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
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