ThromboembolismNCT04305756
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
A study testing Enoxaparin in people with Thromboembolism and Postpartum DVT, run by University of Utah at 1 site in United States.
Trial summary
The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery women. Half of participants will receive a fixed dose of LMWH, while the other half will receive a weight-based dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thromboembolism, Postpartum DVT, Thrombosis
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2020to 15 Dec 2021
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cesarean delivery
- Meet facility guidelines for postpartum venous thromboembolism (VTE) prophylaxis: Presence of 1 major, or 2 or more moderate, risk factors.
- Major risk factors: history of venous thromboembolism, high risk thrombophilia, BMI ≥40, high risk medical comorbidities (heart disease, sickle cell disease, systemic lupus erythematosus, inflammatory bowel disease), cesarean hysterectomy, nephrotic range proteinuria, or cesarean intrapartum/during labor
- Moderate risk factors: BMI > 30, multifetal pregnancy, postpartum hemorrhage (>1L blood loss), tobacco use, non-laboring or elective cesarean, preeclampsia, infection, preterm delivery (< 37 weeks gestational age), age > 35 years, low risk thrombophilia, family history of venous thromboembolism, stillbirth, varicose veins, prolonged labor (> 24 hours)
Who cannot join
- Contraindication to anticoagulation
- Plan for therapeutic anticoagulation (antepartum or postpartum)
- Known renal dysfunction (Creatinine clearance < 30 mL/minute)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery women. Half of participants will receive a fixed dose of LMWH, while the other half will receive a weight-based dose. The hypothesis is that the use of a weight-based dose will result in more women reaching prophylactic levels.
Read the detailed description
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The immediate postpartum period is a high risk time for VTE, and cesarean delivery is an additional risk factor. In the United States, use of postpartum VTE prophylaxis with low-molecular weight heparin (LMWH) is commonly used but without a standard protocol or dose across all hospitals. A fixed-dose of LMWH is frequently used based on data from non-obstetric studies. However, there are concerns that in the postpartum population this fixed dose may not be adequate for prophylaxis.
This study aims to evaluate the efficacy of fixed dose versus weight-based LMWH to reach prophylactic anti-Xa levels in post-cesarean delivery women. This will be a randomized controlled trial (RCT) with half of participants receiving a fixed dose of LMWH and half of participants receiving a weight-based dose of LMWH. The hypothesis is that the use of a weight-based LMWH compared to a fixed dose will result in more women achieving prophylactic anti-Xa levels.
- Conditions
- Thromboembolism, Postpartum DVT, Thrombosis
- Being tested
- Enoxaparin
- Keywords
- Factor Xa, Biomarkers, Enoxaparin
- Medical subject headings
- Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Lovenox
Low molecular weight heparin
| Study group | Role | What they receive |
|---|---|---|
| Weight-based LMWH | Experimental | Participants will receive a weight-based dose of prophylactic enoxaparin.
- For all BMI groups: 0.5mg/kg rounded to the nearest 10mg will be injected subcutaneously every 12 hours Receives: Drug: Enoxaparin |
| Fixed LMWH | Active comparator | Participants will receive a fixed dose of prophylactic enoxaparin.
* For BMI <40: 40mg injected subcutaneously every 24 hours
* For BMI > or = to 40: 40mg injected subcutaneously every 12 hours Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prophylactic peak anti-Xa level
Anti-Xa level in prophylactic range (0.2 to 0.6 IU/mL)
Measured: Postoperative day #3 at peak (4-6 hours post-dose)
Secondary outcomes (2)
Venous thromboembolism
Presence of venous thromboembolism as confirmed on diagnostic imaging
Measured: From delivery through 6 weeks postpartum
Wound Complications
Post-cesarean wound hematoma
Measured: From delivery through 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start12 Jun 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torri Metz, University of Utah
- Investigators
- Torri Metz, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305756
- Sponsor's protocol ID
- 130494
- Status last verified
- Jan 2022
- First submitted
- 9 Mar 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bruno AM, Allshouse AA, Campbell HM, Branch DW, Lim MY, Silver RM, Metz TD. Weight-Based Compared With Fixed-Dose Enoxaparin Prophylaxis After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2022 Oct 1;140(4):575-583. doi: 10.1097/AOG.0000000000004937. Epub 2022 Sep 7.
PubMed 36075079
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04305756
- Acronym / sponsor ID
- 130494
- Conditions
- Thromboembolism, Postpartum DVT, Thrombosis
- Keywords
- Factor Xa, Biomarkers, Enoxaparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 12 Mar 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.
The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery women. Half of participants will receive a fixed dose of LMWH, while the other half will receive a weight-based dose. The hypothesis is that the use of a weight-based dose will result in more women reaching prophylactic levels.
Detailed description
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The immediate postpartum period is a high risk time for VTE, and cesarean delivery is an additional risk factor. In the United States, use of postpartum VTE prophylaxis with low-molecular weight heparin (LMWH) is commonly used but without a standard protocol or dose across all hospitals. A fixed-dose of LMWH is frequently used based on data from non-obstetric studies. However, there are concerns that in the postpartum population this fixed dose may not be adequate for prophylaxis.
This study aims to evaluate the efficacy of fixed dose versus weight-based LMWH to reach prophylactic anti-Xa levels in post-cesarean delivery women. This will be a randomized controlled trial (RCT) with half of participants receiving a fixed dose of LMWH and half of participants receiving a weight-based dose of LMWH. The hypothesis is that the use of a weight-based LMWH compared to a fixed dose will result in more women achieving prophylactic anti-Xa levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-based LMWH | Experimental | Drug: EnoxaparinParticipants will receive a weight-based dose of prophylactic enoxaparin. - For all BMI groups: 0.5mg/kg rounded to the nearest 10mg will be injected subcutaneously every 12 hours |
| Fixed LMWH | Active comparator | Drug: EnoxaparinParticipants will receive a fixed dose of prophylactic enoxaparin. * For BMI <40: 40mg injected subcutaneously every 24 hours * For BMI > or = to 40: 40mg injected subcutaneously every 12 hours |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cesarean delivery
- Meet facility guidelines for postpartum venous thromboembolism (VTE) prophylaxis: Presence of 1 major, or 2 or more moderate, risk factors.
- Major risk factors: history of venous thromboembolism, high risk thrombophilia, BMI ≥40, high risk medical comorbidities (heart disease, sickle cell disease, systemic lupus erythematosus, inflammatory bowel disease), cesarean hysterectomy, nephrotic range proteinuria, or cesarean intrapartum/during labor
- Moderate risk factors: BMI > 30, multifetal pregnancy, postpartum hemorrhage (>1L blood loss), tobacco use, non-laboring or elective cesarean, preeclampsia, infection, preterm delivery (< 37 weeks gestational age), age > 35 years, low risk thrombophilia, family history of venous thromboembolism, stillbirth, varicose veins, prolonged labor (> 24 hours)
Key exclusion criteria (3 listed)
- Contraindication to anticoagulation
- Plan for therapeutic anticoagulation (antepartum or postpartum)
- Known renal dysfunction (Creatinine clearance < 30 mL/minute)
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 |
|---|---|---|
| EnoxaparinAlso: LovenoxLow molecular weight heparin | Drug | Fixed LMWH, Weight-based LMWH |
Primary outcome
Prophylactic peak anti-Xa level
Time frame: Postoperative day #3 at peak (4-6 hours post-dose)
Anti-Xa level in prophylactic range (0.2 to 0.6 IU/mL)
2 secondary outcomes
Venous thromboembolism
Time frame: From delivery through 6 weeks postpartum
Wound Complications
Time frame: From delivery through 6 weeks postpartum
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 28 Jan 2022.
- Derived from this study: PubMed 36075079Bruno AM, Allshouse AA, Campbell HM, Branch DW, Lim MY, Silver RM, Metz TD. Weight-Based Compared With Fixed-Dose Enoxaparin Prophylaxis After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2022 Oct 1;140(4):575-583. doi: 10.1097/AOG.0000000000004937. Epub 2022 Sep 7.
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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.
Torri Metz, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin in people with Thromboembolism and Postpartum DVT, run by University of Utah at 1 site in United States.
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 3 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 28 Jan 2022. 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 United States. 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?
Prophylactic peak anti-Xa level (time frame: Postoperative day #3 at peak (4-6 hours post-dose)). 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 NCT04305756, which also lists 1 linked publication.
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 28 Jan 2022.