Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01338454
First received: April 11, 2011
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention Phase
Obstetrical Hemorrhage
Drug: transamin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Erzincan Military Hospital:

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. [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 ≥1000 ml

  • need for additional uterotonic drugs [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    nausea, vomiting or diarrhea


Enrollment: 450
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tranexamic acid
TA administered intravenously over a 5 min period at delivery of the anterior shoulder
Drug: transamin
TA was administered intravenously over a 5 min period at delivery of the anterior shoulder
No Intervention: saline
10 mL of saline was administered intravenously over a 5 min period at delivery of the anterior shoulder

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338454

Locations
Turkey
Bakıryok Women and Children Hospital
İstanbul, Bakırkoy, Turkey, 34142
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

No publications provided by Erzincan Military Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kemal GUNGORDUK, medical doctor, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT01338454     History of Changes
Other Study ID Numbers: gungorduk12
Study First Received: April 11, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration
Turkey: Ministry of Health

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014