Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study (PREFER-PP)

June 9, 2023 updated by: Marc Blondon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Justine Hugon-Rodin
  • Switzerland
      • Geneve, Switzerland, 1205
        • Marc Blondon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • fetal or neonatal death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant / postpartum women
Adult women during pregnancy or the early postpartum period (within 7 days of delivery)
Other: Interview
Structured interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preference for postpartum thromboprophylaxis
Time Frame: 90 days of delivery
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
Time Frame: 90 days of delivery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Blondon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2021

Primary Completion (Actual)

October 7, 2022

Study Completion (Actual)

October 7, 2022

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGeneva 2021-01336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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