Postpartum HemorrhageTXA; CDNCT05759156
Tranexamic Acid in Patients for Caesarian Delivery.
A study testing Tranexamic acid injection in people with Postpartum Hemorrhage and Cesarean Section Complications, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Cesarean Section Complications, Obstetric Anesthesia Problems
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 572 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2023to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Autoimmune disorders
- Sickle cell disease
- Placenta Previa
- Abruptio Placentae
- Eclampsia or HELLP syndrome
- Women who might undergo intraoperative complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).
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.
- Being tested
- Tranexamic acid injection
- Keywords
- caesarian delivery, postpartum haemorrhage, obstetrics quality of recovery, tranexamic acid
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Active comparator | Not described Receives: Drug: Tranexamic acid injection |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postpartum haemorrhage (PPH)
Measured: up to 2 days
Obstetrics quality of recovery (ObsQoR) score
Measured: at 2 days
Secondary outcomes (7)
Measurement of postpartum blood loss
Measured: at 2 days
Operative time
Measured: up to 3 hours
Length of hospital stay
Measured: up to 4 days
Frequency of emergency surgery for postpartum haemorrhage
Measured: up to 12 hours
Rate of ICU transfer
Measured: up to 1 day
Rate of Maternal death
Measured: up to 3 months
Adverse events related to tranexamic acid
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start20 Mar 2023
- Primary completion5 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atif Shafqat, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759156
- Sponsor's protocol ID
- 2891
- Acronym
- TXA; CD
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).
- ClinicalTrials.gov ID
- NCT05759156
- Acronym / sponsor ID
- TXA; CD / 2891
- Keywords
- caesarian delivery, postpartum haemorrhage, obstetrics quality of recovery, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Active comparator | Drug: Tranexamic acid injection |
| Normal Saline | Placebo comparator | Drug: Tranexamic acid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionThe 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. | Drug | Normal Saline, Tranexamic Acid |
Primary outcome
Occurrence of postpartum haemorrhage (PPH)
Time frame: up to 2 days
Obstetrics quality of recovery (ObsQoR) score
Time frame: at 2 days
7 secondary outcomes
Measurement of postpartum blood loss
Time frame: at 2 days
Operative time
Time frame: up to 3 hours
Length of hospital stay
Time frame: up to 4 days
Frequency of emergency surgery for postpartum haemorrhage
Time frame: up to 12 hours
Rate of ICU transfer
Time frame: up to 1 day
Rate of Maternal death
Time frame: up to 3 months
Adverse events related to tranexamic acid
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection in people with Postpartum Hemorrhage and Cesarean Section Complications, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postpartum haemorrhage (PPH) (time frame: up to 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.