Venous Thromboembolic DiseasesNCT01588171
Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum
A study testing Bemiparin and Enoxaparin in people with Venous Thromboembolic Diseases, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis. Read more about this study
- Who is it for?
- Ages 15 to 48 years, women only
- Conditions the study is for
- Venous Thromboembolic Diseases
- What is being tested?
- Bemiparin and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,020 participants
- Where
- 1 siteIraq
- Study dates
- May 2012to Nov 2013
- 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 15 to 48 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of risk factors for venous thromboembolism
- Any parity
- Mode of delivery:vaginal, Emergency and Elective Caesarean section
- No any contraindications for Heparin
Who cannot join
- Active antenatal or postpartum vaginal bleeding.
- Placenta previa
- Thrombocytopenia
- Sever renal or liver diseases
- Uncontrolled sever hypertension
- Any patient who is already on Heparin during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial
The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis.
Read the detailed description
Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the developed and developing world. Pulmonary embolism and deep vein thrombosis are the two components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The highest incidence occurring during the post partum period. There are many researches done a broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them alone and both together against a control group. Also according to our knowledge there are no published literature on thromboprophylaxis after vaginal delivery
- Conditions
- Venous Thromboembolic Diseases
- Being tested
- Bemiparin, Enoxaparin
- Keywords
- Deep vein thrombosis, Pulmonary embolism, Low molecular weight heparin, Enoxaparin, Bemiparin
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
Also called Hibor; Laboratories Rovi Pharmaceuticals
Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days.
EnoxaparinDrug
Also called Clexane(Sanofi aventis)
Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Bemiparin | Active comparator | A new second generation Low Molecular Weight Heparin Receives: Drug: Bemiparin; Drug: Enoxaparin |
| Enoxaparin | Active comparator | A well known Low Molecular Weight Heparin Receives: Drug: Enoxaparin |
| control group | No intervention | Participants assigned to the Non-Interventional Arm will receive standard local hospital care as dictated by the attending physician and established clinical guidelines. Examples of standard care include, but are not limited to, patient rehydration protocols and support for ambulation or mobilization within the clinical setting. All standard safety and monitoring procedures will apply. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism
compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.
Measured: 40 days after delivery
Secondary outcomes (1)
adverse effects
bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence
Measured: after receiving the injections and till 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolic DiseasesStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- A prospective clinical trial with sequential group allocation Women eligible for participation were assigned to the three arms of the trial: the bemiparin, enoxaparin, and control groups. Based on a schema produced by a Microsoft Excel (2007) computer program, the first woman was recruited to the non intervention group (control), the second to the bemiparin group, and the third to the enoxaparin group, with this sequence repeated throughout the trial
- Masking
- None (open label)
- Enrolment
- 7,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHAHLA KAREEM ALALAF, Hawler Medical University
- Investigators
- Shahla K. Alalaf, Ass.Prof, Principal investigator, Hawler Medical UniversityRojan K. Jawad, High Diploma, Study chair, Hawler Medical UniversityParez R. Muhammad, High Diploma, Study chair, Hawler Medical UniversityMahabad S. Ali, High Diploma, Study chair, Hawler ministry of Health, Directorate of HealthNamir G. Al Tawil, Professor, Study director, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588171
- Sponsor's protocol ID
- Hawler Medical University
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2012
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
PubMed 33779986Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.
PubMed 25884460
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01588171
- Acronym / sponsor ID
- Hawler Medical University
- Conditions
- Venous Thromboembolic Diseases
- Keywords
- Deep vein thrombosis, Pulmonary embolism, Low molecular weight heparin, Enoxaparin, Bemiparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,020 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Apr 2012 (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 use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis.
Detailed description
Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the developed and developing world. Pulmonary embolism and deep vein thrombosis are the two components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The highest incidence occurring during the post partum period. There are many researches done a broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them alone and both together against a control group. Also according to our knowledge there are no published literature on thromboprophylaxis after vaginal delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A prospective clinical trial with sequential group allocation Women eligible for participation were assigned to the three arms of the trial: the bemiparin, enoxaparin, and control groups. Based on a schema produced by a Microsoft Excel (2007) computer program, the first woman was recruited to the non intervention group (control), the second to the bemiparin group, and the third to the enoxaparin group, with this sequence repeated throughout the trial
| Arm | Type | Receives |
|---|---|---|
| Bemiparin | Active comparator | Drug: Bemiparin, Drug: EnoxaparinA new second generation Low Molecular Weight Heparin |
| Enoxaparin | Active comparator | Drug: EnoxaparinA well known Low Molecular Weight Heparin |
| control group | No intervention | –Participants assigned to the Non-Interventional Arm will receive standard local hospital care as dictated by the attending physician and established clinical guidelines. Examples of standard care include, but are not limited to, patient rehydration protocols and support for ambulation or mobilization within the clinical setting. All standard safety and monitoring procedures will apply. |
Who may qualify
- Ages
- 15 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Presence of risk factors for venous thromboembolism
- Any parity
- Mode of delivery:vaginal, Emergency and Elective Caesarean section
- No any contraindications for Heparin
Key exclusion criteria (6 listed)
- Active antenatal or postpartum vaginal bleeding.
- Placenta previa
- Thrombocytopenia
- Sever renal or liver diseases
- Uncontrolled sever hypertension
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 |
|---|---|---|
| BemiparinAlso: Hibor; Laboratories Rovi PharmaceuticalsBemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days. | Drug | Bemiparin |
| EnoxaparinAlso: Clexane(Sanofi aventis)Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients. | Drug | Bemiparin, Enoxaparin |
Primary outcome
Venous thromboembolism
Time frame: 40 days after delivery
compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.
1 secondary outcome
adverse effects
Time frame: after receiving the injections and till 40 days
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 21 Nov 2025.
- Derived from this study: PubMed 33779986Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
- Derived from this study: PubMed 25884460Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.
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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.
Shahla K. Alalaf, Ass.Prof principal investigator
Hawler Medical University
Rojan K. Jawad, High Diploma study chair
Hawler Medical University
Parez R. Muhammad, High Diploma study chair
Hawler Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bemiparin and Enoxaparin in people with Venous Thromboembolic Diseases, run by Hawler Medical University at 1 site in Iraq.
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 4 inclusion and 6 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 21 Nov 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 Iraq. 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?
Venous thromboembolism (time frame: 40 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588171, which also lists 2 linked publications.
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 21 Nov 2025.