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The effect of intravenous tranexamic acid on blood loss after vaginal delivery

The effect of intravenous tranexamic acid on blood loss after vaginal delivery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012072910324N2
Enrollment
120
Registered
2012-08-09
Start date
2012-08-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postpartum haemorrhage. Other immediate postpartum haemorrhage

Interventions

Intervention 1: Intervention group: After delivery of anterior shoulder, 1g tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes. Intervention 2: Control group: After
Treatment - Drugs
Placebo
Intervention group: After delivery of anterior shoulder, 1g tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes.
Control group: After delivery of anterior shoulder, 1g placebo of tranexamic acid in 200 ml normal saline will be infused intravenously over 10 minutes.

Sponsors

Womens Reproductive Health Research center, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: -Women with singleton pregnancy between 38 to 42 weeks - Cephalic presentation - No history of cesarean section or uterine surgery - No history of uterine myoma - Normal blood pressure - No history of postpartum haemorrhage - No history of coagulation disorders - No history of heart disease - No history of renal disease - No history of blood disorders and anemia - No history of cerebrovascular disease - Absence of diabetes and preeclampsia in pregnancy current - Absence of polyhydramnious of macrosomia in the current pregnancy - lack of long-term induction of labor in first stage Exclusion criteria: - Instrumental delivery - Extensive vaginal and cervical lacerations - Need for placenta curettag - Continuous pressure in the fundus of the uterus before the fetus and placenta expulsion.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Comparison of measured blood loss after delivery in the intervention group (receiving tranexamic acid and oxytocin) and control group ( receiving placebo of tranexamic acid and oxytocin). Timepoint: first two hours after delivery. Method of measurement: Differences between the weight of the full and empty container and the dry and bloody plastic cover, drapes and quaze pads will be recorded during the first two hours after delivery and blood loss will be assessed by the method of Gai et al.;Comparison of the calculated blood loss after delivery in the intervention group (receiving tranexamic acid and oxytocin) and control group ( receiving placebo tranexamic acid and oxytocin). Timepoint: Before and 12-24 hours after delivery. Method of measurement: Calculated blood loss will be assessed according to pre- and post delivery hematocrit.

Secondary

MeasureTime frame
Comparison of postdelivery hematocrit with effect control of predelivery hematocrit between intervention group(receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: Before and 12-24 hours after delivery. Method of measurement: hematocrit assessment.;Comparison of postdelivery Hemoglobin with effect control of predelivery Hemoglobin between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: Before and 12-24 hours after delivery. Method of measurement: Hemoglobin assessment.;Comparison of the mean duration of the third stage of labor between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: From newborn delivery to exclusion of the placenta. Method of measurement: Check of the time in second.;Comparsion of need for additional uterotonic medication after delivery between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: 30, 45, 60, 90 and 120 minute after delivery. Method of measurement: Checklist.;Comparison of vital signs between intervention group (receiving tranexamic acid and oxytocin) and control group (receiving placebo of tranexamic acid and oxytocin). Timepoint: 15-30-45-60-90 and 120minutes after delivery. Method of measurement: cheklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mojgan Mirghafourvand

Tabriz University of Medical Sciences, Nursing & Midwifery Faculty

Mirghafourvandm@tbzmed.ac.ir, Mirg1385@yahoo.com+98 41 1479 6770

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026