Cesarean Section ComplicationsNCT03778242
Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.
A study testing Topical tranexamic acid and normal saline in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Topical tranexamic acid and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jul 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
Who cannot join
- placenta praevia and placental abruption
- Women with a medical disorder,
- placenta accrete,
- allergy to TA, and
- intraoperative bleeding thanks to causes aside from uterine atony
- Patients over 40 or who have
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- pre-existing coagulation disorders,
- with a severe medical disorder
- allergy to tranexamic acid
- refuse to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: A Randomized Controlled Trial
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section
Read the detailed description
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.
- Conditions
- Cesarean Section Complications
- Being tested
- Topical tranexamic acid, normal saline
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage, oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical tranexamic acidDrug
Also called Active Comparator
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
normal salineDrug
Also called Placebo comparator
2 placebo ampoules to TA in 100 ml saline by slow infusion
| Study group | Role | What they receive |
|---|---|---|
| Topical tranexamic acid | Active comparator | temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid Receives: Drug: Topical tranexamic acid |
| normal saline | Placebo comparator | temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients need of additional pharmacological uterotonic
calculation number of patients need of additional pharmacological uterotonic
Measured: 24 hours post operative
Secondary outcomes (3)
estimation of intraoperative blood loss (ml)
measure Intraoperative blood loss in ml by gravimetric methods
Measured: during the operation
amount of postoperative blood loss
measure amount of blood loss post operative in ml by gravimetric methods
Measured: 4 hours postoperative
number of patient with postpartum hemorrhage
calculation of the number of the patients with blood loss >1000 ml
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019
- Primary completion30 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Model description
- open label Randomized Clinical Tria
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778242
- Sponsor's protocol ID
- aswu/276/18
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03778242
- Acronym / sponsor ID
- aswu/276/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Dec 2018 (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.
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section
Detailed description
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label Randomized Clinical Tria
| Arm | Type | Receives |
|---|---|---|
| Topical tranexamic acid | Active comparator | Drug: Topical tranexamic acidtemporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid |
| normal saline | Placebo comparator | Drug: normal salinetemporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
Key exclusion criteria (10 listed)
- placenta praevia and placental abruption
- Women with a medical disorder,
- placenta accrete,
- allergy to TA, and
- intraoperative bleeding thanks to causes aside from uterine atony
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 |
|---|---|---|
| Topical tranexamic acidAlso: Active Comparatortemporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid | Drug | Topical tranexamic acid |
| normal salineAlso: Placebo comparator2 placebo ampoules to TA in 100 ml saline by slow infusion | Drug | normal saline |
Primary outcome
number of patients need of additional pharmacological uterotonic
Time frame: 24 hours post operative
calculation number of patients need of additional pharmacological uterotonic
3 secondary outcomes
estimation of intraoperative blood loss (ml)
Time frame: during the operation
amount of postoperative blood loss
Time frame: 4 hours postoperative
number of patient with postpartum hemorrhage
Time frame: 24 hours post operative
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 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical tranexamic acid and normal saline in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
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 1 inclusion and 10 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 Apr 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 Egypt. 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?
number of patients need of additional pharmacological uterotonic (time frame: 24 hours post operative). 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 Apr 2023.