Stillbirth and Fetal DeathNCT06771661
Parents' Experience of Child Loss During Pregnancy or Birth
An observational study of Stillbirth and Fetal Death and Miscarriages, run by Fritz Sterr at 1 site in Germany.
Trial summary
The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stillbirth and Fetal Death, Miscarriages, Experience
- What is being tested?
- Workshops, Focus group interviews and Narrative interviews
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2024to 1 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Parents (mothers, fathers) will be recruited that lost their child during pregnancy or birth in hospitals, at home or birth houses.
Who may be able to join
- German speaking
- Living in Austria, Germany or Switzerland
- Child loss during pregnancy or birth
- Child loss within last 12 months
- Legal capacity
- Voluntary participation
Who cannot join
- Loss of child after birth
- Not speaking and understanding German
- Not in a good mental condition to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
Deggendorf, Bavaria, 94469
About this study
Official title: Parents' Experience of Child Loss During Pregnancy or Birth - an Explorative, Sequential Mixed-methods Study
The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss.
Read the detailed description
The entire study is following a participatory approach and including parents after stillbirth in the research team. Along a co-creative design, the investigators planned a multistep-explorative mixed-methods study.
In detail, three key steps will be conducted. First, workshops and focus groups will be carried out to identify central needs of affected parents. Afterwards, one investigator will interview the parents narratively to gain an in-depth understanding of their experiencs. Finally, these findings will be summarized and translated into treatment recommendations for healthcare professionals.
- Conditions
- Stillbirth and Fetal Death, Miscarriages, Experience
- Being tested
- Workshops, Focus group interviews, Narrative interviews, Delphi approach
- Keywords
- Pregnancy loss, Child loss, Qualitative research, Mixed-methods, Experience, Need, Parents, Perinatal loss, Fetal death, Miscarriage, Stillbirth
- Medical subject headings
- Stillbirth, Fetal Death, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkshopsOther
The investigators will conduct workshops with parents to get closer to the main topic.
Focus group interviewsOther
The investigators will conduct focus group interviews with parents on their needs before and during child loss.
Narrative interviewsOther
The investigators will conduct narrative interviews with parents to gain an in-depth understanding of their lived experience before and during the intrauterine or perinatal child loss.
Delphi approachOther
The investigators will carry out a Delphi approach with parents to translate and confirm or revise the findings into treatment recommendations for healthcare professionals.
| Study group | Role | What they receive |
|---|---|---|
| Parents after intrauterine or perinatal child loss | Not described Receives: Other: Workshops; Other: Focus group interviews; Other: Narrative interviews; Other: Delphi approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent's experience
The investigators are interested in parents' in-depth and lived experience before and during their intrauterine or perinatal child loss.
Measured: During pregnancy and up to 7 days after birth
Secondary outcomes (1)
Parents' subjective needs
In qualitative interviews, the subjective needs that parents developed before and during their intrauterine or perinatal child loss will be investigated.
Measured: During pregnancy and up to 7 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start2 Dec 2024
- Primary completion17 Jul 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stillbirth and Fetal DeathStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fritz Sterr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fritz Sterr, Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
- Investigators
- Christian Rester, Prof. Dr., Study chair, Deggendorf Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771661
- Sponsor's protocol ID
- GEHBa-202409-V-237-R2
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data to be collected is particularly sensitive and is stored securely and deleted after the study. Individual pseudonymised excerpts are made public in the publications.
Publications
Sterr F, Siepmann J, Nuber-Fischer D, Rester C, Gensheimer K, Bauernfeind L. Parents' experience of child loss during pregnancy or birth: protocol for an explorative, sequential and participative mixed-methods study. Res Involv Engagem. 2025 Dec 5;11(1):139. doi: 10.1186/s40900-025-00819-8.
PubMed 41350907Siepmann J, Bauernfeind L, Nuber-Fischer D, Rester C, Gensheimer K, Sterr F. Needs of parents during their intrauterine or perinatal child loss - a qualitative multi-method study. BMC Public Health. 2026 May 12;26(1):1526. doi: 10.1186/s12889-026-27687-5.
PubMed 42121131
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Experience of Child Loss During Pregnancy or Birth - an Explorative, Sequential Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06771661
- Acronym / sponsor ID
- GEHBa-202409-V-237-R2
- Conditions
- Stillbirth and Fetal Death, Miscarriages, Experience
- Keywords
- Pregnancy loss, Child loss, Qualitative research, Mixed-methods, Experience, Need, Parents, Perinatal loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fritz SterrUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 13 Jan 2025 (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.
The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss.
Detailed description
The entire study is following a participatory approach and including parents after stillbirth in the research team. Along a co-creative design, the investigators planned a multistep-explorative mixed-methods study.
In detail, three key steps will be conducted. First, workshops and focus groups will be carried out to identify central needs of affected parents. Afterwards, one investigator will interview the parents narratively to gain an in-depth understanding of their experiencs. Finally, these findings will be summarized and translated into treatment recommendations for healthcare professionals.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents after intrauterine or perinatal child loss | – | Other: Workshops, Other: Focus group interviews, Other: Narrative interviews, Other: Delphi approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents (mothers, fathers) will be recruited that lost their child during pregnancy or birth in hospitals, at home or birth houses.
Key inclusion criteria (6 listed)
- German speaking
- Living in Austria, Germany or Switzerland
- Child loss during pregnancy or birth
- Child loss within last 12 months
- Legal capacity
Key exclusion criteria (3 listed)
- Loss of child after birth
- Not speaking and understanding German
- Not in a good mental condition to participate
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 |
|---|---|---|
| WorkshopsThe investigators will conduct workshops with parents to get closer to the main topic. | Other | Parents after intrauterine or perinatal child loss |
| Focus group interviewsThe investigators will conduct focus group interviews with parents on their needs before and during child loss. | Other | Parents after intrauterine or perinatal child loss |
| Narrative interviewsThe investigators will conduct narrative interviews with parents to gain an in-depth understanding of their lived experience before and during the intrauterine or perinatal child loss. | Other | Parents after intrauterine or perinatal child loss |
| Delphi approachThe investigators will carry out a Delphi approach with parents to translate and confirm or revise the findings into treatment recommendations for healthcare professionals. | Other | Parents after intrauterine or perinatal child loss |
Primary outcome
Parent's experience
Time frame: During pregnancy and up to 7 days after birth
The investigators are interested in parents' in-depth and lived experience before and during their intrauterine or perinatal child loss.
1 secondary outcome
Parents' subjective needs
Time frame: During pregnancy and up to 7 days after birth
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 31 Aug 2026.
- Background: PubMed 41350907Sterr F, Siepmann J, Nuber-Fischer D, Rester C, Gensheimer K, Bauernfeind L. Parents' experience of child loss during pregnancy or birth: protocol for an explorative, sequential and participative mixed-methods study. Res Involv Engagem. 2025 Dec 5;11(1):139. doi: 10.1186/s40900-025-00819-8.
- Results publication: PubMed 42121131Siepmann J, Bauernfeind L, Nuber-Fischer D, Rester C, Gensheimer K, Sterr F. Needs of parents during their intrauterine or perinatal child loss - a qualitative multi-method study. BMC Public Health. 2026 May 12;26(1):1526. doi: 10.1186/s12889-026-27687-5.
- Landing Page of the StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data to be collected is particularly sensitive and is stored securely and deleted after the study. Individual pseudonymised excerpts are made public in the publications.
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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.
Christian Rester, Prof. Dr. study chair
Deggendorf Institute of Technology
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 Stillbirth and Fetal Death and Miscarriages, run by Fritz Sterr at 1 site in Germany.
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 31 Aug 2026. 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 Germany. 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?
Parent's experience (time frame: During pregnancy and up to 7 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06771661, which also lists 2 linked publications.
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 31 Aug 2026.