PregnancyPREFER-PPNCT05318547
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the PREFER-PostPartum
A study testing standard-gamble technique and time trade-off technique in people with Pregnancy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The risk of venous thromboembolism (VTE), which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE), increases during pregnancy and most strikingly in the postpartum period (6 weeks after delivery). Extensive research efforts have led to the identification of many risk factors for VTE events. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- standard-gamble technique and time trade-off technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2022to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years
- Ongoing pregnancy or in the early postpartum period (within 7 days of delivery)
- Participants may be with or without prior VTE or major bleeding, and with or without previous/current use of postpartum TPX.
- Fluency in French
- Women are able and willing to give free, informed and written consent
Who cannot join
- Fetal or neonatal death, in order not to bother women during their mourning.
- Women under tutorship or curatorship
- Women deprived of liberty
- Women under court protection There will be no further exclusion criteria, to maximize the external validity of the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Justine P Hugon-Rodin, MD, 0144123934 ext. +33, jhugon@ghpsj.fr
About this study
The risk of venous thromboembolism (VTE), which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE), increases during pregnancy and most strikingly in the postpartum period (6 weeks after delivery). Extensive research efforts have led to the identification of many risk factors for VTE events. Examples of such factors include maternal characteristics (personal history of VTE, thrombophilia, obesity, race) and obstetrical characteristics (methods of delivery, pre-term delivery, growth retardation). These allow care providers to risk stratify women at the time of delivery into low, moderate and high-risk women, based on experts' opinion. Further, a risk score, which was recently developed and validated on English and Swedish populations, estimates the risk of postpartum VTE in individuals.
Thromboprophylaxis (TPX) focuses on the use of short-term low-molecular-weight heparin (LMWH). LMWH is believed to reduce the risk of VTE by 50-70%, but the evidence is indirect, with a lack of large-scale randomized trial in the setting of the postpartum period. Further, LMWH is both inconvenient (subcutaneous injections) and possibly associated with haemorrhagic side effects. Alternative drugs do not exist, because direct oral anticoagulants (DOAC) and aspirin are not studied in this setting and because DOAC are contra-indicated in pregnancy and breastfeeding.
Read more
Given the unclear balance of benefits and risks, current guidelines vary greatly in the proportion of women with recommended TPX. Gassmann et al. have recently demonstrated, among a cohort of parturients at the Geneva University Hospitals: a recommendation of postpartum TPX in 40.1% of women, with an estimated mean risk of postpartum VTE of 0.12%, according to the 2015 UK guidelines (RCOG), and a recommendation of postpartum TPX in 8.7% of women, with an estimated mean risk of postpartum VTE of 0.20%, according to the 2018 US guidance (ACOG).These low risks of VTE to trigger a recommendation of TPX use contrast with that of experts' opinions, which advocate for a threshold of VTE risk of 1-3% to recommend the use of TPX. Currently, all women delivering by C-section in Geneva receive TPX regardless of their VTE risk.
This dramatic discrepancy of TPX guidance between guidelines, and between guidelines and individual experts, highlights the uncertainty in this setting. Womens' preferences would be critically important here, to guide a rationale and desired use of TPX. Quite surprisingly, such preferences have never been elicited, in spite of the very large number of births every year (5 and 4 million in Europe and the US, respectively).
To inform prescription patterns of postpartum TPX, investigators propose to conduct this prospective study to elicit values and preferences of pregnant and postpartum women.
- Conditions
- Pregnancy
- Being tested
- standard-gamble technique, time trade-off technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard-gamble techniqueOther
Participants will be asked to imagine a scenario in which they are experiencing one of the 4 described conditions in the long-term. They will declare their preference between (a) keeping this long-term condition as is, or using a painless hypothetical cure that is associated with some risk of death, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision whether to take the treatment or not. The utility will be calculated as 1 - the obtained risk of death of the point of equipoise. Health states will be evaluted in different orders across participants.
The elicitation of health state utilites by the standard-gamble technique is further clarified.
time trade-off techniqueOther
Participants will be asked to declare their preference between 50 years of life with the symptoms of 1 of the conditions, or 50-X years without these symptoms, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision on the preference of the 2 choices. The utility will be calculated as the 50-x/50 obtained at this point of equipoise. Health states will be evaluted in different orders across participants.
| Study group | Role | What they receive |
|---|---|---|
| standard-gamble technique | Experimental | Participants will be asked to imagine a scenario in which they are experiencing one of the 4 described conditions in the long-term. They will declare their preference between (a) keeping this long-term condition as is, or using a painless hypothetical cure that is associated with some risk of death, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision whether to take the treatment or not. The utility will be calculated as 1 - the obtained risk of death of the point of equipoise. Health states will be evaluted in different orders across participants.
The elicitation of health state utilites by the standard-gamble technique is further clarified. Receives: Other: standard-gamble technique |
| time trade-off technique | Experimental | Participants will be asked to declare their preference between 50 years of life with the symptoms of 1 of the conditions, or 50-X years without these symptoms, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision on the preference of the 2 choices. The utility will be calculated as the 50-x/50 obtained at this point of equipoise. Health states will be evaluted in different orders across participants. Receives: Other: time trade-off technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of the Threshold of Risk for Postpartum Venous Thromboembolism
This outcome corresponds to the threshold of risk of postpartum Venous thromboembolism at which women prefer the use of short-term postpartum TPX with LMWH over no treatment.
Measured: Day 1
Secondary outcomes (4)
Correlation of the time of interview (antenatal vs. postnatal) with the risk threshold
This outcome corresponds to the determinants of this threshold within the time of interview (antenatal vs. postnatal).
Measured: Day 1
Correlation of demographic factors with the risk threshold
This outcome corresponds tof this threshold within the time of interview (antenatal vs. postnatal), demographic factors.
Measured: Day 1
Correlation of medical factors with the risk threshold
This outcome corresponds to tDeterminants of this threshold within the time of interview (antenatal vs. postnatal) medical factors.
Measured: Day 1
Correlation of obstetric factors with the risk threshold
This outcome corresponds to the Determinants of this threshold within the time of interview (antenatal vs. postnatal), obstetrical factors.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start13 May 2022
- Primary completion12 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine P Hugon Rodin, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318547
- Sponsor's protocol ID
- PREFER-PP
- Acronym
- PREFER-PP
- Status last verified
- Aug 2023
- First submitted
- 30 Dec 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.
PubMed 18248600Blondon M, Quon BS, Harrington LB, Bounameaux H, Smith NL. Association between newborn birth weight and the risk of postpartum maternal venous thromboembolism: a population-based case-control study. Circulation. 2015 Apr 28;131(17):1471-6; discussion 1476. doi: 10.1161/CIRCULATIONAHA.114.012749. Epub 2015 Mar 5.
PubMed 25745022Blondon M, Harrington LB, Boehlen F, Robert-Ebadi H, Righini M, Smith NL. Pre-pregnancy BMI, delivery BMI, gestational weight gain and the risk of postpartum venous thrombosis. Thromb Res. 2016 Sep;145:151-6. doi: 10.1016/j.thromres.2016.06.026. Epub 2016 Jun 24.
PubMed 27421192Sultan AA, West J, Grainge MJ, Riley RD, Tata LJ, Stephansson O, Fleming KM, Nelson-Piercy C, Ludvigsson JF. Development and validation of risk prediction model for venous thromboembolism in postpartum women: multinational cohort study. BMJ. 2016 Dec 5;355:i6253. doi: 10.1136/bmj.i6253.
PubMed 27919934Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.
PubMed 11442521Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.
PubMed 25884460Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.
PubMed 30482767
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 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
- ClinicalTrials.gov ID
- NCT05318547
- Acronym / sponsor ID
- PREFER-PP / PREFER-PP
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 12 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Apr 2022 (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 risk of venous thromboembolism (VTE), which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE), increases during pregnancy and most strikingly in the postpartum period (6 weeks after delivery). Extensive research efforts have led to the identification of many risk factors for VTE events. Examples of such factors include maternal characteristics (personal history of VTE, thrombophilia, obesity, race) and obstetrical characteristics (methods of delivery, pre-term delivery, growth retardation). These allow care providers to risk stratify women at the time of delivery into low, moderate and high-risk women, based on experts' opinion. Further, a risk score, which was recently developed and validated on English and Swedish populations, estimates the risk of postpartum VTE in individuals.
Thromboprophylaxis (TPX) focuses on the use of short-term low-molecular-weight heparin (LMWH). LMWH is believed to reduce the risk of VTE by 50-70%, but the evidence is indirect, with a lack of large-scale randomized trial in the setting of the postpartum period. Further, LMWH is both inconvenient (subcutaneous injections) and possibly associated with haemorrhagic side effects. Alternative drugs do not exist, because direct oral anticoagulants (DOAC) and aspirin are not studied in this setting and because DOAC are contra-indicated in pregnancy and breastfeeding.
Given the unclear balance of benefits and risks, current guidelines vary greatly in the proportion of women with recommended TPX. Gassmann et al. have recently demonstrated, among a cohort of parturients at the Geneva University Hospitals: a recommendation of postpartum TPX in 40.1% of women, with an estimated mean risk of postpartum VTE of 0.12%, according to the 2015 UK guidelines (RCOG), and a recommendation of postpartum TPX in 8.7% of women, with an estimated mean risk of postpartum VTE of 0.20%, according to the 2018 US guidance (ACOG).These low risks of VTE to trigger a recommendation of TPX use contrast with that of experts' opinions, which advocate for a threshold of VTE risk of 1-3% to recommend the use of TPX. Currently, all women delivering by C-section in Geneva receive TPX regardless of their VTE risk.
This dramatic discrepancy of TPX guidance between guidelines, and between guidelines and individual experts, highlights the uncertainty in this setting. Womens' preferences would be critically important here, to guide a rationale and desired use of TPX. Quite surprisingly, such preferences have never been elicited, in spite of the very large number of births every year (5 and 4 million in Europe and the US, respectively).
To inform prescription patterns of postpartum TPX, investigators propose to conduct this prospective study to elicit values and preferences of pregnant and postpartum women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard-gamble technique | Experimental | Other: standard-gamble techniqueParticipants will be asked to imagine a scenario in which they are experiencing one of the 4 described conditions in the long-term. They will declare their preference between (a) keeping this long-term condition as is, or using a painless hypothetical cure that is associated with some risk of death, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision whether to take the treatment or not. The utility will be calculated as 1 - the obtained risk of death of the point of equipoise. Health states will be evaluted in different orders across participants. The elicitation of health state utilites by the standard-gamble technique is further clarified. |
| time trade-off technique | Experimental | Other: time trade-off techniqueParticipants will be asked to declare their preference between 50 years of life with the symptoms of 1 of the conditions, or 50-X years without these symptoms, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision on the preference of the 2 choices. The utility will be calculated as the 50-x/50 obtained at this point of equipoise. Health states will be evaluted in different orders across participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged ≥18 years
- Ongoing pregnancy or in the early postpartum period (within 7 days of delivery)
- Participants may be with or without prior VTE or major bleeding, and with or without previous/current use of postpartum TPX.
- Fluency in French
- Women are able and willing to give free, informed and written consent
Key exclusion criteria (4 listed)
- Fetal or neonatal death, in order not to bother women during their mourning.
- Women under tutorship or curatorship
- Women deprived of liberty
- Women under court protection There will be no further exclusion criteria, to maximize the external validity of the study.
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 |
|---|---|---|
| standard-gamble techniqueParticipants will be asked to imagine a scenario in which they are experiencing one of the 4 described conditions in the long-term. They will declare their preference between (a) keeping this long-term condition as is, or using a painless hypothetical cure that is associated with some risk of death, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision whether to take the treatment or not. The utility will be calculated as 1 - the obtained risk of death of the point of equipoise. Health states will be evaluted in different orders across participants. The elicitation of health state utilites by the standard-gamble technique is further clarified. | Other | standard-gamble technique |
| time trade-off techniqueParticipants will be asked to declare their preference between 50 years of life with the symptoms of 1 of the conditions, or 50-X years without these symptoms, with the help of a visual aid on a laptop or tablet. A ping-pong technique will be applied until the point of equipoise is reached, when there is indecision on the preference of the 2 choices. The utility will be calculated as the 50-x/50 obtained at this point of equipoise. Health states will be evaluted in different orders across participants. | Other | time trade-off technique |
Primary outcome
Definition of the Threshold of Risk for Postpartum Venous Thromboembolism
Time frame: Day 1
This outcome corresponds to the threshold of risk of postpartum Venous thromboembolism at which women prefer the use of short-term postpartum TPX with LMWH over no treatment.
4 secondary outcomes
Correlation of the time of interview (antenatal vs. postnatal) with the risk threshold
Time frame: Day 1
Correlation of demographic factors with the risk threshold
Time frame: Day 1
Correlation of medical factors with the risk threshold
Time frame: Day 1
Correlation of obstetric factors with the risk threshold
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 18248600Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.
- Background: PubMed 25745022Blondon M, Quon BS, Harrington LB, Bounameaux H, Smith NL. Association between newborn birth weight and the risk of postpartum maternal venous thromboembolism: a population-based case-control study. Circulation. 2015 Apr 28;131(17):1471-6; discussion 1476. doi: 10.1161/CIRCULATIONAHA.114.012749. Epub 2015 Mar 5.
- Background: PubMed 27421192Blondon M, Harrington LB, Boehlen F, Robert-Ebadi H, Righini M, Smith NL. Pre-pregnancy BMI, delivery BMI, gestational weight gain and the risk of postpartum venous thrombosis. Thromb Res. 2016 Sep;145:151-6. doi: 10.1016/j.thromres.2016.06.026. Epub 2016 Jun 24.
- Background: PubMed 27919934Sultan AA, West J, Grainge MJ, Riley RD, Tata LJ, Stephansson O, Fleming KM, Nelson-Piercy C, Ludvigsson JF. Development and validation of risk prediction model for venous thromboembolism in postpartum women: multinational cohort study. BMJ. 2016 Dec 5;355:i6253. doi: 10.1136/bmj.i6253.
- Background: PubMed 11442521Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.
- Background: PubMed 25884460Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.
- Background: PubMed 30482767Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.
- Risks of Venous Thromboembolism After Cesarean SectionLink provided by the sponsor.
- Reducing the Risk of Venous Thromboembolism during Pregnancy and the PuerperiumLink provided by the sponsor.
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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.
Justine P Hugon Rodin, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard-gamble technique and time trade-off technique in people with Pregnancy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justine Hugon Rodin, MD (144123934 ext. +33, jhugon@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definition of the Threshold of Risk for Postpartum Venous Thromboembolism (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318547, which also lists 7 linked publications.
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 9 Aug 2023.