Modified Delphi for Genomic Bereavement Care

NCT05655741 | Completed

• 1 other identifier: CG22/151813
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Anomaly; Bereavement; Genetic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Delphi Panel

Participants who meet the inclusion criteria ,who are willing to complete the 3 questionnaires within the study.

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Delphi Panel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• Genomic Medicine Services Alliance: collaborator

Study Sites (1)

Leeds Teaching Hospitals Trust

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Congenital Abnormalities; Genetic Diseases, Inborn

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Abigail Hyland, MBBS

  Leeds Teaching Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: December 19, 2022
• Study Start: October 28, 2022
• Primary Completion: March 17, 2023
• Study Completion: March 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)