Postpartum Heparin Against Venous Thromboembolism: a Pilo... | NCT05878899

Studies
Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

NCT05878899

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

May 26, 2023Actual

Enrollment

77Actual

Phase

Phase 3

Conditions

Venous Thromboembolism

Interventions

Enoxaparin

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2022Actual

Primary Completion Date

Mar 13, 2023Actual

Completion Date

Mar 13, 2023Actual

First Submitted Date

Mar 6, 2023

First Submission Date that Met QC Criteria

May 24, 2023

First Posted Date

May 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2023

Last Update Posted Date

May 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enoxaparin	Experimental	Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.	Drug: Enoxaparin
No treatment	No Intervention	No treatment.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enoxaparin	Drug	Prophylactic dose of enoxaparin once daily for 10 days after delivery.	Enoxaparin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recruitement rate	Number of study inclusion per month	6 months
Study participation	Proportion of eligible women who are presented the study and who accept to participate	Within 48 hours after delivery

Secondary Outcomes

Measure	Description	Time Frame
Venous thromboembolism	Pulmonary embolism and deep vein thrombosis	Within 90 day after delivery
Bleeding	Major and clinically relevant non-major bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: adult women within 48h of delivery, with:

≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility
and/or ≥1 of the following risk factors: Emergency cesarean section Pre-pregnancy BMI ≥35kg/m2 Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) Pre-eclampsia Pre-term delivery (<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight <5th percentile)

Exclusion Criteria:

any indication for therapeutic anticoagulation
a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
an increased bleeding risk
a contra-indication to the use of heparin

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospitals		Geneva		1205	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39238110	Derived	Blondon M, Claver M, Celetta E, Righini M, de Tejada BM. Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial. BJOG. 2025 Jan;132(1):35-43. doi: 10.1111/1471-0528.17943. Epub 2024 Sep 5.

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides