Clinical trial NCT05655741: Modified Delphi for Genomic Bereavement Care
Official title: Developing Best Practice for Genomic Bereavement Care in Pregnancy Loss: A Modified Delphi Consensus Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Anomaly
Bereavement
Genetic Disease
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Genomic Medicine Services Alliance
First posted: 2022-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be contacted via email with an advert for the study in order to declare an expression of interest. Relevant groups will include; BMFMS members, Fetal Genomics Group steering group for those with prenatal interests, BRIPPA members for pathologists with an interest in perinatal pathology, Laboratory leads for each GMSA, a bereavement midwife from each GMSA.

Brief summary: It is estimated that 1 in 4 pregnancies end in loss, be these early miscarriages, ectopic pregnancies, or later intrauterine losses for any reason. Genomics is a major part of pregnancy loss, and clinicians want to offer the best and most appropriate test available to women and their families, whilst ensuring that there is equity in the access to this testing, so that no family goes through a loss without the right support and information. Whilst there is limited information to inform professionals as to how to incorporate genomics into bereavement care there is a need to identify current expert consensus as to how this should be performed, in order to make recommendations for best practice.

Detailed description: There is a lack of guidance available as to how to care for women and families who suffer a pregnancy loss where fetal anomalies have been found and a genetic cause is suspected. As it is estimated that 1 in 4 pregnancies end in loss, these families make up a significant proportion of the population that maternity services care for and with no consensus in this area many families may have a poor experience.

As the field of genomics rapidly advances, it is important that patient care reflects the changes in practice and that the most appropriate tests and support are offered. All aspects of patient care will be reviewed including diagnosis, delivery, laboratory investigations, postnatal care and follow up in future pregnancies. The role of the genomics midwife will be explored and the role of the bereavement midwife will be further defined when it comes to support following pregnancy loss where there is likely an underlying genomic cause.

The aim of this modified delphi study is to understand what the current expert consensus is for genomic bereavement care. Using this, best practice guidance will be written that can be used within the NHS to better support families who suffer pregnancy loss during this pregnancy and in the future.

Eligibility criteria: Inclusion Criteria:

* Participants must belong to one of the relevant stakeholder groups; Maternal and fetal medicine consultants or obstetricians with a special interest in fetal medicine, Clinical geneticists with an interest in prenatal genomics, Perinatal pathologists Clinical scientists with an interest in genomics, Bereavement midwives.

Exclusion Criteria:

* Nil if inclusion criteria are met

Primary outcomes:
measure: Identify consensus for best practice for genomic bereavement care
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals Trust
Study officials:
affiliation: Leeds Teaching Hospitals Trust
name: Abigail Hyland, MBBS
role: PRINCIPAL_INVESTIGATOR
References: