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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05655741
Other study ID # CG22/151813
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 28, 2022
Est. completion date March 31, 2023

Study information

Verified date April 2023
Source The Leeds Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 31, 2023
Est. primary completion date March 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Other:
Questionnaire
Participants will be asked to complete a series of 3 questionnaires that will be used to gain insight into the current expert consensus for Genomic Bereavement care for Pregnancy Loss. The 2nd and 3rd Questionnaire will be modified from the first to try to generate consensus, depending on the answers from the previous round.

Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals Trust Leeds

Sponsors (2)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust Genomic Medicine Services Alliance

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify consensus for best practice for genomic bereavement care Consensus will be achieved if >80% of participants agree or strongly agree with the statement using a 5 point likert scale. 26 weeks
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