BleedingPROCSNCT01321788
Venous Thromboembolism Prophylaxis Post Cesarean Section
An observational study of Bleeding and Venous Thromboembolism, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Bleeding, Venous Thromboembolism
- What is being tested?
- TINZAPARIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2011to Jan 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: Consecutive adult patients (aged over 18 years) that had been delivered by emergency or elective cesarean section with no previous history of VTE are eligible for the study.
Who may be able to join
- Age > 18 years old.
- Delivered by cesarean section (emergency or planned).
- Signed, informed consent.
- Ready access to a local health service.
- Capable of using Tinzaparin.
Who cannot join
- at high risk for thromboembolism (any one of the following):
- age more than 35 years old
- obesity (more than 80 kg)
- parity more than 4
- gross varicose veins
- current infection
Show all 20Show fewer
- pre-eclampsia
- immobility prior to surgery (more than 4 days)
- Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome.
- Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)
- Patients with a family history of VTE
- History of superficial phlebitis
- More than 36 hours since delivery
- Need for anticoagulation, including:
- women with a confirmed thrombophilia
- women with paralysis of lower limbs
- women with personal history of VTE
- women with antiphospholipid antibody syndrome (APLA)
- women with mechanical heart valves
- Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Security Forces Hospital
Riyadh, Riyadh Region
Farjah H AlGahtani, MD, 0505805919, falgahtani@ksu.edu.sa
Pharm
About this study
Official title: Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)
Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy-related VTE occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.
Read the detailed description
This is a double blind- a randomized controlled study of prophylactic LMWH in women at low risk for VTE following a cesarean section procedure. The sample size is 300 patients, Eligible, consenting, and randomized participants will receive once-daily injections of study drug (4,500 IU Tinzaparin Sodium [Innohep®] within 12- to 24-hours postpartum and continue for two weeks versus Placebo in the other arm and follow for six (6) weeks postpartum.
On the day of hospital discharge, bilateral leg imaging with compression, leg ultrasounds, and pelvic vein imaging with MRV will be completed. The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period. All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation.
- Conditions
- Bleeding, Venous Thromboembolism
- Being tested
- TINZAPARIN, PLACEBO
- Keywords
- thromboprophylaxis, pregnancy, post-cesarian section
- Medical subject headings
- Hemorrhage, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TINZAPARINDrug
Also called Innohep
Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.
PLACEBODrug
Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | will receive the study drug Innohep ® for 14 days Receives: Drug: TINZAPARIN | |
| CONTROL | The group that will receive placebo for 14 days Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Vein Thrombosis
The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.
Measured: 24 months
Secondary outcomes (1)
symptomatic DVT and bleeding
. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period.
Measured: Symptomatic DVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Responsible party
- Principal investigator, Farjah Hassan AlGahtani, King Saud University
- Investigators
- FARJAH H ALGAHTANI, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321788
- Sponsor's protocol ID
- PRO-CS TRIAL
- Acronym
- PROCS
- Status last verified
- Feb 2012
- First submitted
- 22 Mar 2011
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kujovich JL. Hormones and pregnancy: thromboembolic risks for women. Br J Haematol. 2004 Aug;126(4):443-54. doi: 10.1111/j.1365-2141.2004.05041.x.
PubMed 15287937Samuelsson E, Hellgren M, Hogberg U. Pregnancy-related deaths due to pulmonary embolism in Sweden. Acta Obstet Gynecol Scand. 2007;86(4):435-43. doi: 10.1080/00016340701207500.
PubMed 17486465Morris JM, Algert CS, Roberts CL. Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. doi: 10.1111/j.1538-7836.2010.03794.x. Epub 2010 Feb 1.
PubMed 20128859Chan WS. Venous thromboembolism in pregnancy. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1731-40. doi: 10.1586/erc.10.169.
PubMed 21108555Middleton 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 33779986
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)
- ClinicalTrials.gov ID
- NCT01321788
- Acronym / sponsor ID
- PROCS / PRO-CS TRIAL
- Conditions
- Bleeding, Venous Thromboembolism
- Keywords
- thromboprophylaxis, pregnancy, post-cesarian section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 24 Mar 2011 (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.
Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy-related VTE occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.
Detailed description
This is a double blind- a randomized controlled study of prophylactic LMWH in women at low risk for VTE following a cesarean section procedure. The sample size is 300 patients, Eligible, consenting, and randomized participants will receive once-daily injections of study drug (4,500 IU Tinzaparin Sodium [Innohep®] within 12- to 24-hours postpartum and continue for two weeks versus Placebo in the other arm and follow for six (6) weeks postpartum.
On the day of hospital discharge, bilateral leg imaging with compression, leg ultrasounds, and pelvic vein imaging with MRV will be completed. The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period. All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | – | Drug: TINZAPARINwill receive the study drug Innohep ® for 14 days |
| CONTROL | – | Drug: PLACEBOThe group that will receive placebo for 14 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Consecutive adult patients (aged over 18 years) that had been delivered by emergency or elective cesarean section with no previous history of VTE are eligible for the study.
Key inclusion criteria (5 listed)
- Age > 18 years old.
- Delivered by cesarean section (emergency or planned).
- Signed, informed consent.
- Ready access to a local health service.
- Capable of using Tinzaparin.
Key exclusion criteria (20 listed)
- at high risk for thromboembolism (any one of the following):
- More than 36 hours since delivery
- Need for anticoagulation, including:
- Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.
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 |
|---|---|---|
| TINZAPARINAlso: InnohepEligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum. | Drug | STUDY GROUP |
| PLACEBOEligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum. | Drug | CONTROL |
Primary outcome
Deep Vein Thrombosis
Time frame: 24 months
The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.
1 secondary outcome
symptomatic DVT and bleeding
Time frame: Symptomatic DVT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
- Background: PubMed 15287937Kujovich JL. Hormones and pregnancy: thromboembolic risks for women. Br J Haematol. 2004 Aug;126(4):443-54. doi: 10.1111/j.1365-2141.2004.05041.x.
- Background: PubMed 17486465Samuelsson E, Hellgren M, Hogberg U. Pregnancy-related deaths due to pulmonary embolism in Sweden. Acta Obstet Gynecol Scand. 2007;86(4):435-43. doi: 10.1080/00016340701207500.
- Background: PubMed 20128859Morris JM, Algert CS, Roberts CL. Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. doi: 10.1111/j.1538-7836.2010.03794.x. Epub 2010 Feb 1.
- Background: PubMed 21108555Chan WS. Venous thromboembolism in pregnancy. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1731-40. doi: 10.1586/erc.10.169.
- 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.
- Venous Thromboembolism During PregnancyLink provided by the sponsor.
- Venous Thromboembolism in Pregnancy StudyLink provided by the sponsor.
- Venous thromboembolism in pregnancyLink provided by the sponsor.
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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.
FARJAH H ALGAHTANI, MD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Venous Thromboembolism, run by King Saud University at 1 site in Saudi Arabia.
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 5 inclusion and 20 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 6 Feb 2012. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FARJAH H ALGAHTANI, MD (0505805919, falgahtani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep Vein Thrombosis (time frame: 24 months). 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 NCT01321788, which also lists 5 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 6 Feb 2012.