Thromboembolism in the PuerperiumPhase 4NCT04447378
Safety of Fondaparinux as Post Partum Thromboprophylaxis
A Phase 4 study testing Fondaparinux 2.5Mg/0.5Ml Inj Syr in people with Thromboembolism in the Puerperium, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. 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
- Thromboembolism in the Puerperium
- What is being tested?
- Fondaparinux 2.5Mg/0.5Ml Inj Syr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2017to 1 Jun 2018
- Phase
- Phase 4
- 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
- Malaysian
- Age 18 and above
- Scores asintermediate risk on 2015 Royal College of Obstetricians \& Gynaecologists (RCOG) VTE risk assessment
Who cannot join
- Hypersensitivity to fondaparinux
- Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease.
- Weight < 50 kg
- Patients with primary postpartum haemorrhage
- Patients who already on anti - coagulants
- Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user
- Uncontrolled hypertension ( blood pressure > 200 mmHg systolic or > 120 mmHg diastolic )
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre
Cheras, Kuala Lumpur, 56000
About this study
Official title: Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis.
The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.
Read the detailed description
All women were taught the injection technique and counselled regarding the symptoms of bleeding and VTE, prior to discharge. All patients were also advised to wear compression stockings and ensure adequate hydration at home
The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded.
- Conditions
- Thromboembolism in the Puerperium
- Being tested
- Fondaparinux 2.5Mg/0.5Ml Inj Syr
- Keywords
- pregnancy, thromboembolism, prophylaxis
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux 2.5Mg/0.5Ml Inj SyrDrug
Also called N/A; single arm study
post natal thromboprophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Fondaparinux | Experimental | Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis Receives: Drug: Fondaparinux 2.5Mg/0.5Ml Inj Syr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism (VTE)
VTE occurence of either deep vein thrombosis or pulmonary embolism
Measured: Within six weeks of delivery
Secondary outcomes (4)
Major Bleeding requiring hospitalisation
Secondary post partum haemorrhage or spinal site bleeding
Measured: within six weeks of delivery
Minor bleeding
Wound site bleeding, skin bruising
Measured: within six weeks of delivery
Allergic reaction
Any allergy symptoms following injection of fondaparinux
Measured: within 24 hours from last injection
Neonatal bleeding tendency
Any bruising of bleeding tendency in neonates
Measured: within six weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Sep 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolism in the PuerperiumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Hani Mohd Kalok, National University of Malaysia
- Investigators
- Nor Azlin Mohamed Ismail, MBCHB, MMED, Principal investigator, Faculty of Medicine, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447378
- Sponsor's protocol ID
- JEP -2017-543
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is available upon request
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
- ClinicalTrials.gov ID
- NCT04447378
- Acronym / sponsor ID
- JEP -2017-543
- Conditions
- Thromboembolism in the Puerperium
- Keywords
- pregnancy, thromboembolism, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 25 Jun 2020 (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.
Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis.
The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.
Detailed description
All women were taught the injection technique and counselled regarding the symptoms of bleeding and VTE, prior to discharge. All patients were also advised to wear compression stockings and ensure adequate hydration at home
The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fondaparinux | Experimental | Drug: Fondaparinux 2.5Mg/0.5Ml Inj SyrSubcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Malaysian
- Age 18 and above
- Scores asintermediate risk on 2015 Royal College of Obstetricians \& Gynaecologists (RCOG) VTE risk assessment
Key exclusion criteria (7 listed)
- Hypersensitivity to fondaparinux
- Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease.
- Weight < 50 kg
- Patients with primary postpartum haemorrhage
- Patients who already on anti - coagulants
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 |
|---|---|---|
| Fondaparinux 2.5Mg/0.5Ml Inj SyrAlso: N/A; single arm studypost natal thromboprophylaxis | Drug | Fondaparinux |
Primary outcome
Venous thromboembolism (VTE)
Time frame: Within six weeks of delivery
VTE occurence of either deep vein thrombosis or pulmonary embolism
4 secondary outcomes
Major Bleeding requiring hospitalisation
Time frame: within six weeks of delivery
Minor bleeding
Time frame: within six weeks of delivery
Allergic reaction
Time frame: within 24 hours from last injection
Neonatal bleeding tendency
Time frame: within six weeks of delivery
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 26 Jun 2020.
- Individual participant dataSharing planned: No. IPD is available upon request
Related trials for Thromboembolism in the Puerperium
RecruitingObservational study
THROmbinography in Pregnant Woman and in Vitro Action of Low Molecular Weight HEparin
Pregnant Women, Venous Thromboembolic Disease
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.
Nor Azlin Mohamed Ismail, MBCHB, MMED principal investigator
Faculty of Medicine, National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fondaparinux 2.5Mg/0.5Ml Inj Syr in people with Thromboembolism in the Puerperium, run by National University of Malaysia at 1 site in Malaysia.
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 7 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 26 Jun 2020. 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 Malaysia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Venous thromboembolism (VTE) (time frame: Within six weeks of delivery). 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 26 Jun 2020.