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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02678208

Collaborator

(none)

200

Enrollment

Location

Arms

5.9

Duration (Months)

33.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Tranexamic Acid Drug: 5% glucose	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tranexamic acid received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period	Drug: Tranexamic Acid Drug: 5% glucose
Other: placebo received 30 mL of 5% glucose over the same period of time.	Drug: 5% glucose

Arm

Intervention/Treatment

Active Comparator: Tranexamic acid

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

Drug: Tranexamic Acid

Drug: 5% glucose

Other: placebo

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

Drug: 5% glucose

Outcome Measures

Primary Outcome Measures

The changes in Doppler indices of uterine artery after use of tranexamic acid [6 months]
The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid [6 months]
The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid [6 month]

Secondary Outcome Measures

The volume of blood loss after delivery (mL) [6 months]
Number of patients needed for blood transfusion [6 months]
The hematocrit values (%) [6 months]
The hemoglobin concentration [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Khairy Ali, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02678208

Other Study ID Numbers:

TBBH

First Posted:

Feb 9, 2016

Last Update Posted:

Mar 1, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Postpartum Hemorrhage

Hemorrhage

Tranexamic Acid

Study Results

No Results Posted as of Mar 1, 2016