Fetal DeathSPANNCT03795857
Antenatal Palliative Care
An observational study of Fetal Death and Fetal Anomaly, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fetal Death, Fetal Anomaly
- What is being tested?
- Semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Jan 2019to 11 Apr 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will focus on couples who have been diagnosed with lethal fetal pathology and who have chosen to continue the pregnancy for a birth in palliative care. The death of the child may have occurred in utero or after birth.
Who may be able to join
- The woman must be between the ages of 18 and 50 and the adult,
- Participants must have received the information and not have objected to participating in the study,
- the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),
- The choice to continue the pregnancy should have been clearly expressed,
- The birth of the child should not be older than 24 months.
- The child's death must be more than 6 months old (or not have occurred)
Who cannot join
- Non-mastery of the French language,
- Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),
- Severe psychiatric or neurological disorders inducing significant cognitive impairment.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon
Bron, 69677
Service de gynécologie obstétrique - Hôpital de la Croix Rousse
Lyon, 69004
Service de gynécologie-obstétrique - Centre hospitalier Lyon sud
Pierre-Bénite, 69495
About this study
Official title: Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.
In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.
The aim of the study is to describe parents' experience for a better understanding and a better care.
- Conditions
- Fetal Death, Fetal Anomaly
- Being tested
- Semi-structured interviews
- Medical subject headings
- Fetal Death, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsBehavioural
The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis
The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.
Measured: About 1 hour and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start14 Jan 2019
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DeathStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795857
- Sponsor's protocol ID
- 69HCL18_0371
- Acronym
- SPAN
- Status last verified
- Aug 2019
- First submitted
- 2 Jan 2019
- Last updated
- 29 Aug 2019
- 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 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.
- ClinicalTrials.gov ID
- NCT03795857
- Acronym / sponsor ID
- SPAN / 69HCL18_0371
- Conditions
- Fetal Death, Fetal Anomaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 8 Jan 2019 (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.
In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.
The aim of the study is to describe parents' experience for a better understanding and a better care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on couples who have been diagnosed with lethal fetal pathology and who have chosen to continue the pregnancy for a birth in palliative care. The death of the child may have occurred in utero or after birth.
Key inclusion criteria (6 listed)
- The woman must be between the ages of 18 and 50 and the adult,
- Participants must have received the information and not have objected to participating in the study,
- the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),
- The choice to continue the pregnancy should have been clearly expressed,
- The birth of the child should not be older than 24 months.
Key exclusion criteria (3 listed)
- Non-mastery of the French language,
- Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),
- Severe psychiatric or neurological disorders inducing significant cognitive impairment.
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 |
|---|---|---|
| Semi-structured interviewsThe purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment. | Behavioural | – |
Primary outcome
Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis
Time frame: About 1 hour and 30 minutes
The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.
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 29 Aug 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Death and Fetal Anomaly, run by Hospices Civils de Lyon at 3 sites in France.
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 6 inclusion and 3 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 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis (time frame: About 1 hour and 30 minutes). 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 29 Aug 2019.