Postpartum HemorrhageNCT05429580
Prophylactic Tranexamic Acid Use After Vaginal Delivery
A study testing Tranexamic acid and 5% Dextrose in people with Postpartum Hemorrhage and Vaginal Delivery, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Vaginal Delivery, Prophylactic Tranexamic Acid Use
- What is being tested?
- Tranexamic acid and 5% Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 28 Feb 2022
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnant women
- woman between the ages of 18-45 years
- woman who gave birth at 34 weeks and above
Who cannot join
- Pregnancies with less than 1 hour period between hospitalization and delivery
- Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae
- Women with previous uterine surgery or cesarean section
- Women with a history of thromboembolism
- women with serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomised, Double-blind, Placebo-controlled Trial
In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.
Read the detailed description
It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.
- Being tested
- Tranexamic acid, 5% Dextrose
- Keywords
- tranexamic acid, vaginal delivery, postpartum hemorrhage, active management of vaginal delivery
- 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 acidDrug
given intravenous tranexamic acid
5% DextroseOther
given placebo.
| Study group | Role | What they receive |
|---|---|---|
| postpartum bleeding risks as low-risk | Other | The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo. Receives: Drug: Tranexamic acid; Other: 5% Dextrose |
| postpartum bleeding risks as high-risk | Other | The patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo. Receives: Drug: Tranexamic acid; Other: 5% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The loss of blood at the 3rd and 4th stages of labor
It was calculated by weighing the blood collected with the help of collecting bag and using the estimated blood loss formula.
Measured: 6 month
Secondary outcomes (1)
The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale
The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale association with atony, need for blood transfusion, need for extra uterotonics, and the gastrointestinal side effects of tranexamic acid such as nausea, vomiting, and diarrhea were evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Sep 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429580
- Sponsor's protocol ID
- 2011-KAEK-25 2021/07-22
- Status last verified
- Dec 2023
- First submitted
- 18 Jun 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prophylactic Tranexamic Acid Use After Vaginal Delivery According to Postpartum Hemorrhage Risk: Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05429580
- Acronym / sponsor ID
- 2011-KAEK-25 2021/07-22
- Keywords
- tranexamic acid, vaginal delivery, postpartum hemorrhage, active management of vaginal delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 23 Jun 2022 (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.
In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.
Detailed description
It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postpartum bleeding risks as low-risk | Other | Drug: Tranexamic acid, Other: 5% DextroseThe patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo. |
| postpartum bleeding risks as high-risk | Other | Drug: Tranexamic acid, Other: 5% DextroseThe patients were divided into two groups according to their postpartum bleeding risks as low-risk (240 patients) and high-risk (240 patients), and then the patients in each group were randomly divided into two groups, and some of these pregnant women were given intravenous tranexamic acid and some were given placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton pregnant women
- woman between the ages of 18-45 years
- woman who gave birth at 34 weeks and above
Key exclusion criteria (5 listed)
- Pregnancies with less than 1 hour period between hospitalization and delivery
- Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae
- Women with previous uterine surgery or cesarean section
- Women with a history of thromboembolism
- women with serious illness
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 acidgiven intravenous tranexamic acid | Drug | postpartum bleeding risks as high-risk, postpartum bleeding risks as low-risk |
| 5% Dextrosegiven placebo. | Other | postpartum bleeding risks as high-risk, postpartum bleeding risks as low-risk |
Primary outcome
The loss of blood at the 3rd and 4th stages of labor
Time frame: 6 month
It was calculated by weighing the blood collected with the help of collecting bag and using the estimated blood loss formula.
1 secondary outcome
The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale
Time frame: 6 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 Dec 2023.
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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 and 5% Dextrose in people with Postpartum Hemorrhage and Vaginal Delivery, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 Dec 2023. 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 Turkey (Türkiye). 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. 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?
The loss of blood at the 3rd and 4th stages of labor (time frame: 6 month). 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 Dec 2023.