NCT05897697

Brief Summary

The preferences of pregnant women for postpartum thromboprophylaxis are largely unknown. The aims of this transversal study are to elicit the preferences of pregnant/postpartum women about postpartum thromboprophylaxis in semi-structured interviews, and to estimate the utility of the relevant health states (pulmonary embolism, deep vein thrombosis, postpartum hemorrhage, subcutaneous injections). In this second aim, the investigators will also compare the effect of 2 different techniques to estimate utilities (standard gamble vs. time trade-off), using a randomization of these techniques.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 1, 2023

Last Update Submit

June 9, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Preference for postpartum thromboprophylaxis

    Risk of postpartum venous thromboembolism at which thromboprophylaxis is preferred

    90 days of delivery

  • Quality-of-life of pulmonary embolism, deep vein thrombosis, postpartum hemorrhage and subcutaneous injections

    Measurements of utilities of pulmonary embolism, deep vein thrombosis, postpartum hemorrhage and subcutaneous injections, by standard gamble and time trade-off methods

    90 days of delivery

Study Arms (1)

Pregnant / postpartum women

Adult women during pregnancy or the early postpartum period (within 7 days of delivery)

Other: Interview

Interventions

Structured interview

Pregnant / postpartum women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult women in a current pregnancy or within 7 days of delivery.

You may qualify if:

  • women
  • ongoing pregnancy or within 7 days of delivery
  • fluency in French or English

You may not qualify if:

  • fetal or neonatal death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Justine Hugon-Rodin

Paris, France

Location

Marc Blondon

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 9, 2023

Study Start

September 24, 2021

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations