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

April 11, 2011
November 16, 2011
March 2011
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01338454 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
Not Provided

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Obstetrical Hemorrhage
Drug: transamin
TA was administered intravenously over a 5 min period at delivery of the anterior shoulder
  • Active Comparator: tranexamic acid
    TA administered intravenously over a 5 min period at delivery of the anterior shoulder
    Intervention: Drug: transamin
  • No Intervention: saline
    10 mL of saline was administered intravenously over a 5 min period at delivery of the anterior shoulder
Gungorduk K, Asıcıoğlu O, Yıldırım G, Ark C, Tekirdağ Aİ, Besımoglu 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01338454
gungorduk12
Not Provided
Kemal GUNGORDUK, Erzincan Military Hospital
Erzincan Military Hospital
Not Provided
Not Provided
Erzincan Military Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP