Background
Methods
Design
Data sources and searches
Eligibility criteria
-
• Examined women’s values and preferences for LMWH vs. watchful waiting or alternative anticoagulant therapy.
-
• Examined choices patients make when presented with management options regarding antithrombotic therapy.
-
• Examined women’s experiences and beliefs of LMWH therapy in pregnancy.
Selection of studies and data extraction
Data synthesis and analysis
Appraisal of the evidence
Results
Study and population characteristics
Author, Year, Country [reference] | Objective | Population | Methods | GRADE (Risk of Bias) /CASP (unmet methodological quality criteria) | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Participants, n | Mean age (years) (SD /range) | Education (%) | Race (%) | Pregnancy period, Reason for VTE risk in pregnancy | Indication for the use of LMWH | Study design [Data Collection Methods] | Outcome presentation: Measurement instrument | |||
Anderson, 1993 [43] Canada | To determine the following: (1) whether women requiring subcutaneous heparin therapy during pregnancy preferred administering the drug through an indwelling Teflon catheter as opposed to receiving twice daily subcutaneous injections and (2) the efficacy and feasibility of administering heparin through an indwelling Teflon catheter | 12 | 28.6 | NR | NR | Period: Ante-partum Reason: Previous VTE event | Prevention/ Treatment | Cross-sectional [Questionnaire] | Non-utility: Researchers self-developed questionnaire | Moderate risk of bias |
Multicenter: Canada, USA, Brazil, Finland, Norway and Spain | To compare women's choices regarding thromboprophylaxis during pregnancy | 123 | 33.94 (6.2) | (1) Not complete high school: 13.8% (2) Completed high school: 18.7% (3) Some post-secondary or higher: 67.5% | NR | Period: Ante-partum Reason: Previous VTE event | Prevention | Cross-sectional [Value elicitation exercises and Direct choice exercise] | Utility: Direct techniques: VAS Non-utility: Direct choice exercise | Moderate risk of bias |
Guimicheva 2019 [40] UK | To explore women's views, experiences and adherence to postnatal thromboprophylaxis | 67 | 36.2 (4.4) | NR | Caucasian (73.1) African-Caribbean (23.9) Other (3.0) | Period: Post-partum Reason: Previous obstetric complications | Prevention | Cross-sectional [Questionnaire] | Non-utility: BMQ- questionnaire | Serious risk of bias |
Hordern, 2015 [42] UK | To assess reported patient compliance with a standard course of postnatal thromboprophylaxis in the form of low-molecular-weight heparin (LMWH) | 111 | NR | NR | NR | Period: Post-partum Reason: Multiple risk factors for VTE: Previous VTE event, unprecedented thrombophilia thrombosis, and previous obstetric complications | Prevention | Cross-sectional [Structured interview] | Non-utility: Researchers self-developed questionnaire | Serious risk of bias |
Martens, 2007 [45] Canada | To explore the unique experiences, challenges, and coping strategies of pregnant women diagnosed with thrombophilia and who are on daily heparin injections | 9 | 30 to 36 | NR | NR | Period: Ante-partum and post-partum Reason: Unprecedented thrombophilia thrombosis | Prevention | Qualitative [Semi-structured interview] | Qualitative: Analytical themes | 4 and 6a |
Patel 2012 [44] UK | To monitor women's adherence to enoxaparin when prescribed during pregnancy and the puerperium and to explore women's views and beliefs about the enoxaparin prescribed | 95 (quantitative) 30 (qualitative) | 33.03 years (range 18–46) | NR | Caucasian (56.8) African-Caribbean (31.6) Asian (4.2) Other (7.4) | Period: Ante-partum and post-partum Reason: Multiple risk factors for VTE: Previous VTE event, unprecedented thrombophilia thrombosis, and previous obstetric complications | Prevention/ Treatment | Multiple methodology [questionnaire with open-ended questions] | Non-utility: BMQ- questionnaire Qualitative: Open-ended questions | Moderate risk of bias |
Skeith 2021 [46] Canada | To understand how patients and physicians navigate the decision-making process for use of LMWH and/or ASA in pregnancy | 10 | NR | NR | NR | Period: Ante-partum and post-partum Reason: Unprecedented thrombophilia thrombosis and previous obstetric complications: at least 1 prior late pregnancy loss (> 10 weeks gestation) or 2 early pregnancy losses (< 10 weeks gestation) | Prevention | Qualitative [Semi-structured interview] | Qualitative: Analytical themes | 4 and 6a |
Women’s values and preferences
Quantitative outcomes
Qualitative findings
Mixed-methods results
Mixed-methods themes [ref] | Quantitative outcomes | Qualitative findings | Mixed-methods findings (Confirmation, Expansion, Discordance) | Certainty of the evidence | ||
---|---|---|---|---|---|---|
Pregnancy with LMWH prophylaxis [Bates | Utility Value: Mean VAS scale (0–100) [ref] | Certainty of evidence | Theme(s) [ref], representative quote | Certainty of evidence | ||
Very Low | Attitude towards the decision -making of using LMWH LMWH injections with “minimal side effects, and that, compared to the emotional pain with loss, a little bit of physical pain from a needle is small potatoes] |
Moderate | Confirmation Both datasets confirm the relief of having LMWH as an option far outweighed any temporary discomfort caused by the injections, and reduced anxiety towards the disease | Moderate | ||
Experience of using LMWH during pregnancy Although it wasn’t fun injecting myself it was part of the ritual. …It felt like I was doing something instead of just waiting there to see if I would miscarry. …It felt like I at least had a very, very, very small hand in helping] | Moderate | |||||
Willingness to take heparin | Non-utility: Proportion (%) of women willing to take heparin (instrument [ref]) | Certainty of evidence | Theme(s) [ref], representative quote | CERQUAL assessment | ||
-78.86 (direct choice) -94.5 (RSQb) [Hordern 2015 [42]] |
Very Low
Very Low | Attitude towards the decision -making of using LMWH [Skeith 2021 [46]; Martens 2007 [45]; Patel 2012 [44]] When you want to have a baby … nothing will stop you Definitely gives me piece of mind during pregnancy; without it I would feel very nervous about developing another DVT | Moderate | Expansion Women accepted uncertainty regarding the pregnancy outcome and were willing to take heparin as it was felt they were taking- action on the management of their condition. Most of the women from the qualitative data were using LMWH to prevent pregnancy loss, hence higher risk perception than when used to prevent DVT (as shown by the non-utility values; women at lower risk were less willing to take the medication). Risk perception is correlated with willing to take LMWH | Moderate | |
Non-utility: Median (%) of risk reduction of LMWH to be willing to take (instrument [ref]) | ||||||
3 (probability trade-off) |
Very Low | |||||
Beliefs towards medication | Non-utility: Mean (± a) Necessity- concerns differential (instrument [ref]) | Certainty of the evidence | Theme(s) [ref], representative quote | CERQUAL assessment | Moderate | |
+ (BMQ- Scale) |
Very Low | Concerns about medication I wanted a baby so bad, I was like I don’t care, I’ll do it… the chance of it harming me… |
Moderate | Confirmation Patients focused on safety issues. Women place a higher priority on the impact LMWH has on the unborn baby compared with any impact the medicine may have on them | ||
Non-utility Values: Reasons for not being adherent when using LMWH (% of women) (instrument [ref]) | Certainty of the evidence | Theme(s) [ref], representative quote | CERQUAL assessment | |||
-Bruising (25 (RSQb) [Hordern 2015 [42]] -Forgetting (16.6(RSQb [Hordern 2015 [42]] -Fear or dislike of needles (16.6(RSQb) [Hordern 2015 [42]] | Very Low | Concerns about medication So, then you’ re worried because labor it isn’ t always planned, right, and what if … I mean what if I went into labor at 33 [weeks] and I took [LMWH] yesterday or I took it today and I would worry that I would go into labor; what would ultimately happen, being on the medication and going into labor | Moderate | Expansion Other concerns provided by the qualitative data were regarding withholding injections before delivery and a scheduled labor | Moderate | |
Non-utility Values: Preference for route of administration (Instrument, % of women) ([ref]) | Certainty of the evidence | Theme(s) [ref], representative quote | CERQUAL assessment | |||
Teflon catheter (RSQb) = 83.3 [Anderson 1993] [43] |
Very Low | Experience of using LMWH during pregnancy If there was a way to get injections for enoxaparin via an epipen type device it would be much more tolerable | Moderate | Confirmation Women from both datasets agreed that they preferred devices that would facilitate administration of injections | Moderate | |
Preferred amount of information regarding LMWH | Non-utility Values: Adequate information regarding LMWH (Instrument, % of women) ([ref]) | Certainty of the evidence | Theme(s) [ref], representative quote | CERQUAL assessment | ||
Whether woman had received enough information regarding LMWH (RSQb) = 83.8 [Hordern 2015 [42]] | Very Low | Information needs to inform the decision I have no issues injecting if it is safeguarding mine and the baby’s health but I lack some faith in the safety/side-effects/ general effects of the medicine. Published information on Clexane seems to be contradictory | Low | Discordance While quantitative data showed that patients felt well-informed about their decision; in qualitative data the majority of women felt they had not received enough information to address their concerns. Women expressed feeling confused about how VTE could affect their baby, how it could compromise their own health and why it was particularly relevant during pregnancy | Low | |
Patient involvement in the decision-making I do not have a problem doing injections and was aware of the possibility of the injections before becoming pregnant. However, I think other women might benefit from more time and support around the use of Clexane in their pregnancy | ||||||
Patient involvement in the decision-making I felt pretty involved. I didn’t feel like pressured into taking [LMWH] if I did get pregnant. It was really up to me to say I want to take the injections or not… I felt involved in the decision | Moderate | Expansion Qualitative data informed that women felt involved in the decision-making; healthcare professionals are an important role in support the decision-making process | Moderate | |||
Would have liked more information or training before leaving hospital (RSQb) = 16.6 [Hordern 2015 [42]] | Very Low | Information needs to inform the decision No, I don’t remember being given any information and you are insecure about the whole subject, so you are not prepared to ask questions because you don’t know what to ask | Low | Discordance Datasets are in discordance in whether it was an informed decision-making process. Injection administration technique was an important need of information | Low |