Trial Outcomes & Findings for The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery (NCT NCT01085006)

NCT ID: NCT01085006

Last Updated: 2011-01-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: During the procedure and within 2 hours afterwards
• Results posted on: 2011-01-25

Participant Flow

Participant milestones

Measure	Tranexamic Acid	Normal Saline Infusion
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery

Baseline characteristics by cohort

Measure	Tranexamic Acid n=50 Participants	Normal Saline Infusion n=50 Participants	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	27 years STANDARD_DEVIATION 3.4 • n=5 Participants	27.6 years STANDARD_DEVIATION 4.1 • n=7 Participants	27.3 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: During the procedure and within 2 hours afterwards

Outcome measures

Measure	Tranexamic Acid n=50 Participants	Normal Saline Infusion n=50 Participants
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward	260 ml Interval 200.0 to 350.0	380 ml Interval 200.0 to 560.0

SECONDARY outcome

Timeframe: First 24 hours

Outcome measures

Outcome data not reported

Adverse Events

Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laleh Eslamian

Tehran University of Medical Sciences

Phone: +982184902415

Email: leslamian@tums.ac.ir

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place