Postpartum HemorrhagePhase 1/2NCT02604719
Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH
A Phase 1/2 study testing Tranexamic Acid and Ethamsylate in people with Postpartum Hemorrhage, run by Ahmed Alanwar.
Trial summary
The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid and Ethamsylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2016
- Phase
- Phase 1/2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing elective caesarean section
- Patient having one or more risk factor for PPH
- Multiple pregnancy
- Polyhydramnios (AFI >25cm)
- Macrocosmic baby (>4.5 Kg)
- Prolonged , augmented and obstructed labour
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- Obese patients(BMI >30)
- Premature rapture of membranes
- Previous history of PPH
- Age ≥18 years
- Gestational Age ≥ 35 Weeks
- Informed Oral Consent From The Patient
Who cannot join
- History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
- History of epilepsy or seizure
- Any Known Cardiovascular , renal or liver Disease
- Autoimmune Diseases
- Sickle Cell Disease
- Severe hemorrhagic Disease
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- Placenta Previa.
- Morbidly adherent Placenta
- Abruptio placenta
- Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
- Administration Of low molecular weight heparin or Anti platelets the week before delivery .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial
The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage
Read the detailed description
Research Question:
Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid and Ethamsylate
- 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 and EthamsylateDrug
Also called kapron and dycinon
The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
| Study group | Role | What they receive |
|---|---|---|
| tanexamic acid and Ethamsylate | Experimental | 10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth Receives: Drug: Tranexamic Acid and Ethamsylate |
| placebo | Placebo comparator | 10 ml normal saline will be administered intravenously just after birth Receives: Drug: Tranexamic Acid and Ethamsylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPH defined as blood loss ≥500 cc
measured by pads placed under women buttocks
Measured: the first 24hours
Secondary outcomes (1)
severe PPH (>1000 cc), .
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Alanwar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Alanwar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604719
- Sponsor's protocol ID
- TXA&Ethamsylate-PPH
- Status last verified
- Nov 2015
- First submitted
- 12 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02604719
- Acronym / sponsor ID
- TXA&Ethamsylate-PPH
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ahmed AlanwarUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- 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.
The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage
Detailed description
Research Question:
Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tanexamic acid and Ethamsylate | Experimental | Drug: Tranexamic Acid and Ethamsylate10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth |
| placebo | Placebo comparator | Drug: Tranexamic Acid and Ethamsylate10 ml normal saline will be administered intravenously just after birth |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Women undergoing elective caesarean section
- Patient having one or more risk factor for PPH
- Age ≥18 years
- Gestational Age ≥ 35 Weeks
- Informed Oral Consent From The Patient
Key exclusion criteria (11 listed)
- History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
- History of epilepsy or seizure
- Any Known Cardiovascular , renal or liver Disease
- Autoimmune Diseases
- Sickle Cell Disease
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 and EthamsylateAlso: kapron and dycinonThe intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss. | Drug | placebo, tanexamic acid and Ethamsylate |
Primary outcome
PPH defined as blood loss ≥500 cc
Time frame: the first 24hours
measured by pads placed under women buttocks
1 secondary outcome
severe PPH (>1000 cc), .
Time frame: first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic Acid and Ethamsylate in people with Postpartum Hemorrhage, run by Ahmed Alanwar.
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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed Dr alanwar, MD (+201111486669 ext. 0020, eladwar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPH defined as blood loss ≥500 cc (time frame: the first 24hours). 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 30 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.