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

Pregnancy Clinical Trial

— PREFER-PP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318547
• Other study ID #: PREFER-PP
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: Justine Hugon Rodin, MD
• Phone: 144123934
• Email: jhugon[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 31, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• standard-gamble technique
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 technique
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (7)

Alalaf 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. — View Citation

Bates 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. — View Citation

Blondon 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. — View Citation

Blondon 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. — View Citation

Mismetti 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. — View Citation

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. — View Citation

Sultan 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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).	Day 1
Secondary	Correlation of demographic factors with the risk threshold	This outcome corresponds tof this threshold within the time of interview (antenatal vs. postnatal), demographic factors.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1

External Links

•   Reducing the Risk of Venous Thromboembolism during Pregnancy and the Puerperium
•   Risks of Venous Thromboembolism After Cesarean Section