Venous ThromboembolismPREFER-PPNCT05897697
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
An observational study of Venous Thromboembolism and Pregnancy Related, run by Marc Blondon at 2 sites in 2 countries.
Trial 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… 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
- Venous Thromboembolism, Pregnancy Related
- What is being tested?
- Interview
- How many people
- 122 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Sep 2021to 7 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult women in a current pregnancy or within 7 days of delivery.
Who may be able to join
- women
- ongoing pregnancy or within 7 days of delivery
- fluency in French or English
Who cannot join
- fetal or neonatal death
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Venous Thromboembolism, Pregnancy Related
- Being tested
- Interview
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Structured interview
| Study group | Role | What they receive |
|---|---|---|
| Pregnant / postpartum women | Adult women during pregnancy or the early postpartum period (within 7 days of delivery) Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference for postpartum thromboprophylaxis
Risk of postpartum venous thromboembolism at which thromboprophylaxis is preferred
Measured: 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
Measured: 90 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start24 Sep 2021
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Blondon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Blondon, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897697
- Sponsor's protocol ID
- UGeneva 2021-01336
- Acronym
- PREFER-PP
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
- ClinicalTrials.gov ID
- NCT05897697
- Acronym / sponsor ID
- PREFER-PP / UGeneva 2021-01336
- Conditions
- Venous Thromboembolism, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Marc BlondonUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant / postpartum women | – | Other: InterviewAdult women during pregnancy or the early postpartum period (within 7 days of delivery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women in a current pregnancy or within 7 days of delivery.
Key inclusion criteria (3 listed)
- women
- ongoing pregnancy or within 7 days of delivery
- fluency in French or English
Key exclusion criteria (1 listed)
- fetal or neonatal death
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 |
|---|---|---|
| InterviewStructured interview | Other | Pregnant / postpartum women |
Primary outcome
Preference for postpartum thromboprophylaxis
Time frame: 90 days of delivery
Risk of postpartum venous thromboembolism at which thromboprophylaxis is preferred
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Pregnancy Related, run by Marc Blondon at 2 sites in 2 countries.
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 3 inclusion and 1 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preference for postpartum thromboprophylaxis (time frame: 90 days of delivery). The study lists 2 primary outcomes in all. 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 12 Jun 2023.