Fetal AnomalyNCT05655741
Modified Delphi for Genomic Bereavement Care
An observational study of Fetal Anomaly and Bereavement, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fetal Anomaly, Bereavement, Genetic Disease
- What is being tested?
- Questionnaire
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Nil if inclusion criteria are met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Anomaly, Bereavement, Genetic Disease
- Being tested
- Questionnaire
- Medical subject headings
- Congenital Abnormalities, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Delphi Panel | Participants who meet the inclusion criteria ,who are willing to complete the 3 questionnaires within the study. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start28 Oct 2022
- Primary completion17 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Genomic Medicine Services Alliance
- Responsible party
- Sponsor
- Investigators
- Abigail Hyland, MBBS, Principal investigator, Leeds Teaching Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655741
- Sponsor's protocol ID
- CG22/151813
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Best Practice for Genomic Bereavement Care in Pregnancy Loss: A Modified Delphi Consensus Study.
- ClinicalTrials.gov ID
- NCT05655741
- Acronym / sponsor ID
- CG22/151813
- Conditions
- Fetal Anomaly, Bereavement, Genetic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Genomic Medicine Services Alliance
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delphi Panel | – | Other: QuestionnaireParticipants who meet the inclusion criteria ,who are willing to complete the 3 questionnaires within the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Nil if inclusion criteria are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireParticipants 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. | Other | Delphi Panel |
Primary outcome
Identify consensus for best practice for genomic bereavement care
Time frame: 26 weeks
Consensus will be achieved if >80% of participants agree or strongly agree with the statement using a 5 point likert scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Hyland, MBBS principal investigator
Leeds Teaching Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Anomaly and Bereavement, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify consensus for best practice for genomic bereavement care (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.