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

• Sponsor: Marc Blondon (Other)
• Overall Status: Completed
• CT.gov ID: NCT05897697
• Collaborator: (none)
• Enrollment: 122
• Locations: 2
• Actual Duration (Months): 12.4
• Patients Per Site: 61
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism; Pregnancy Related	Other: Interview

Study Design

• Study Type: Observational
• Actual Enrollment: 122 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
• Actual Study Start Date: Sep 24, 2021
• Actual Primary Completion Date: Oct 7, 2022
• Actual Study Completion Date: Oct 7, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Preference for postpartum thromboprophylaxis [90 days of delivery]

   Risk of postpartum venous thromboembolism at which thromboprophylaxis is preferred

2. Quality-of-life of pulmonary embolism, deep vein thrombosis, postpartum hemorrhage and subcutaneous injections [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women

• ongoing pregnancy or within 7 days of delivery

• fluency in French or English

Exclusion Criteria:

• fetal or neonatal death

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Justine Hugon-Rodin	Paris		France
2	Marc Blondon	Geneve		Switzerland	1205

Sponsors and Collaborators

• Marc Blondon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Blondon, Principal Investigator, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT05897697
• Other Study ID Numbers: UGeneva 2021-01336
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism

Study Results

No Results Posted as of Jun 12, 2023