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Tranexamic Acid in Patients for Caesarian Delivery. (TXA; CD)

Primary Purpose

Postpartum Hemorrhage, Cesarean Section Complications, Obstetric Anesthesia Problems

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Tranexamic acid injection
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postpartum Hemorrhage focused on measuring caesarian delivery, postpartum haemorrhage, obstetrics quality of recovery, tranexamic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: The inclusion criteria will include: Informed consent of the participant All women who are 18 years old or above Gestational age equal or above 34 weeks Women undergoing emergency or elective CD Complete blood count (CBC) within seven days before the CD Exclusion Criteria: The exclusion criteria will include: Women with thromboembolic or bleeding incidents in the past Hypersensitivity to TXA History of epilepsy or seizure Women with abnormal placenta including accreta, increta or percreta Any active cardiovascular, renal, or liver disorders Autoimmune disorders Sickle cell disease Placenta Previa Abruptio Placentae Eclampsia or HELLP syndrome Women who might undergo intraoperative complications.

Sites / Locations

  • DowUHSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic Acid

Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of postpartum haemorrhage (PPH)
Obstetrics quality of recovery (ObsQoR) score

Secondary Outcome Measures

Measurement of postpartum blood loss
Operative time
Length of hospital stay
Frequency of emergency surgery for postpartum haemorrhage
Rate of ICU transfer
Rate of Maternal death
Adverse events related to tranexamic acid

Full Information

First Posted
February 24, 2023
Last Updated
September 5, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05759156
Brief Title
Tranexamic Acid in Patients for Caesarian Delivery.
Acronym
TXA; CD
Official Title
Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Cesarean Section Complications, Obstetric Anesthesia Problems
Keywords
caesarian delivery, postpartum haemorrhage, obstetrics quality of recovery, tranexamic acid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Active Comparator
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.
Primary Outcome Measure Information:
Title
Occurrence of postpartum haemorrhage (PPH)
Time Frame
up to 2 days
Title
Obstetrics quality of recovery (ObsQoR) score
Time Frame
at 2 days
Secondary Outcome Measure Information:
Title
Measurement of postpartum blood loss
Time Frame
at 2 days
Title
Operative time
Time Frame
up to 3 hours
Title
Length of hospital stay
Time Frame
up to 4 days
Title
Frequency of emergency surgery for postpartum haemorrhage
Time Frame
up to 12 hours
Title
Rate of ICU transfer
Time Frame
up to 1 day
Title
Rate of Maternal death
Time Frame
up to 3 months
Title
Adverse events related to tranexamic acid
Time Frame
up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria will include: Informed consent of the participant All women who are 18 years old or above Gestational age equal or above 34 weeks Women undergoing emergency or elective CD Complete blood count (CBC) within seven days before the CD Exclusion Criteria: The exclusion criteria will include: Women with thromboembolic or bleeding incidents in the past Hypersensitivity to TXA History of epilepsy or seizure Women with abnormal placenta including accreta, increta or percreta Any active cardiovascular, renal, or liver disorders Autoimmune disorders Sickle cell disease Placenta Previa Abruptio Placentae Eclampsia or HELLP syndrome Women who might undergo intraoperative complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atif Shafqat, PhD
Phone
+923364407555
Email
atif.shafqat@duhs.edu.pk
Facility Information:
Facility Name
DowUHS
City
Karachi
State/Province
Sind
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atif Shafqat, PhD.
Phone
+923364407555
Email
atif.shafqat@duhs.edu.pk
First Name & Middle Initial & Last Name & Degree
Atif Shafqat, PhD.

12. IPD Sharing Statement

Plan to Share IPD
No

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Tranexamic Acid in Patients for Caesarian Delivery.

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