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The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid
5% glucose
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnant women (37-42 weeks),
  • with spontaneous labor
  • Women who were expected to normal vaginal birth.
  • women with a live fetus.

Exclusion Criteria:

  • multiple gestations
  • polyhydramnios
  • macrocosmic baby
  • grand multipara
  • women with hypertensive disorders
  • previous history of postpartum hemorrhage
  • abnormal placentation (placenta previa or placental abruption)
  • history of any uterine scarring (including cesarean section)
  • history of blood/liver/renal/heart diseases.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Tranexamic acid

placebo

Arm Description

received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period

received 30 mL of 5% glucose over the same period of time.

Outcomes

Primary Outcome Measures

The changes in Doppler indices of uterine artery after use of tranexamic acid
The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid
The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid

Secondary Outcome Measures

The volume of blood loss after delivery (mL)
Number of patients needed for blood transfusion
The hematocrit values (%)
The hemoglobin concentration

Full Information

First Posted
February 5, 2016
Last Updated
February 27, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02678208
Brief Title
The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postpartum hemorrhage is the most common cause of maternal death across the world, responsible for more than 25% of maternal deaths annually. Although effective tools for prevention and treatment of are available, most are not feasible or practical for use in the developing world where many births still occur at home with untrained birth attendants . primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24 hours of delivery of the fetus which affects the general condition. Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide , reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of long-term severe morbidity, and approximately 12% of women who survive postpartum hemorrhagewill have severe anemia. Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Active Comparator
Arm Description
received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period
Arm Title
placebo
Arm Type
Other
Arm Description
received 30 mL of 5% glucose over the same period of time.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Drug
Intervention Name(s)
5% glucose
Primary Outcome Measure Information:
Title
The changes in Doppler indices of uterine artery after use of tranexamic acid
Time Frame
6 months
Title
The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid
Time Frame
6 months
Title
The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid
Time Frame
6 month
Secondary Outcome Measure Information:
Title
The volume of blood loss after delivery (mL)
Time Frame
6 months
Title
Number of patients needed for blood transfusion
Time Frame
6 months
Title
The hematocrit values (%)
Time Frame
6 months
Title
The hemoglobin concentration
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnant women (37-42 weeks), with spontaneous labor Women who were expected to normal vaginal birth. women with a live fetus. Exclusion Criteria: multiple gestations polyhydramnios macrocosmic baby grand multipara women with hypertensive disorders previous history of postpartum hemorrhage abnormal placentation (placenta previa or placental abruption) history of any uterine scarring (including cesarean section) history of blood/liver/renal/heart diseases.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery

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