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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    52
  • sponsor
    Groupe Hospitalier Paris Saint Joseph
Updated on 15 July 2022
thromboembolism

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. 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.

Details
Condition Pregnancy
Treatment standard-gamble technique, time trade-off technique
Clinical Study IdentifierNCT05318547
SponsorGroupe Hospitalier Paris Saint Joseph
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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