Modified Delphi for Genomic Bereavement Care

Developing Best Practice for Genomic Bereavement Care in Pregnancy Loss: A Modified Delphi Consensus Study.

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.

Study Overview

• Status: Completed
• Conditions: Genetic Disease; Bereavement; Fetal Anomaly
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Delphi Panel; Participants who meet the inclusion criteria ,who are willing to complete the 3 questionnaires within the study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: Genomic Medicine Services Alliance
• Investigators: Principal Investigator: Abigail Hyland, MBBS, Leeds Teaching Hospitals Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Genetic Diseases, Inborn
• Other Study ID Numbers: CG22/151813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No