ThromboembolismPhase 2NCT06118957
Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
A Phase 2 study testing Enoxaparin in people with Thromboembolism, run by University of Utah at 1 site in United States.
Trial summary
The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment… 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
- What is being tested?
- Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cesarean delivery at the University of Utah Health
Who cannot join
- Contraindication to anticoagulation
- Plan for therapeutic anticoagulation
- Known renal dysfunction (creatinine clearance <30mL/minute)
- History of venous thromboembolism
- High risk thrombophilia
- Receipt of antepartum anticoagulation for >2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.
Read the detailed description
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.
- Conditions
- Thromboembolism
- Being tested
- Enoxaparin
- Keywords
- Thromboembolism, Enoxaparin, Cesarean delivery
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Experimental | Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days. Receives: Drug: Enoxaparin |
| No treatment | No intervention | Participants will receive no enoxaparin treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures
Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures
Measured: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks
Secondary outcomes (3)
Rate of Venous Thromboembolism
Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism
Measured: 6 Weeks
Rate of Wound Hematoma or Infection
Clinically diagnosed
Measured: 6 Weeks
Rate of Bleeding Complications
Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery)
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start11 Oct 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Bruno, University of Utah
- Investigators
- Ann Bruno, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118957
- Sponsor's protocol ID
- IRB_00167480
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2023
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06118957
- Acronym / sponsor ID
- IRB_00167480
- Conditions
- Thromboembolism
- Keywords
- Thromboembolism, Enoxaparin, Cesarean delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Posted 4 Sep 2025
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 feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.
Detailed description
Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Experimental | Drug: EnoxaparinParticipants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days. |
| No treatment | No intervention | –Participants will receive no enoxaparin treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cesarean delivery at the University of Utah Health
Key exclusion criteria (6 listed)
- Contraindication to anticoagulation
- Plan for therapeutic anticoagulation
- Known renal dysfunction (creatinine clearance <30mL/minute)
- History of venous thromboembolism
- High risk thrombophilia
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 |
|---|---|---|
| EnoxaparinParticipants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days. | Drug | Enoxaparin |
Primary outcome
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures
Time frame: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks
Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures
3 secondary outcomes
Rate of Venous Thromboembolism
Time frame: 6 Weeks
Rate of Wound Hematoma or Infection
Time frame: 6 Weeks
Rate of Bleeding Complications
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ann Bruno, 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 Phase 2 study testing Enoxaparin in people with Thromboembolism, 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 1 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 4 Sep 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 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.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures (time frame: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks). 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 4 Sep 2025.