- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771661
Parents' Experience of Child Loss During Pregnancy or Birth
Parents' Experience of Child Loss During Pregnancy or Birth - an Explorative, Sequential Mixed-methods Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fritz Sterr, M.Sc.
- Phone Number: +49-991-3615-8344
- Email: fritz.sterr@th-deg.de
Study Contact Backup
- Name: Julian Siepmann, M.Sc.
- Phone Number: +49-991-3615-8368
- Email: julian.siepmann@th-deg.de
Study Locations
-
-
Bavaria
-
Deggendorf, Bavaria, Germany, 94469
- Recruiting
- Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
-
Contact:
- Fritz Sterr, M.Sc.
- Phone Number: +49-991-3615-8344
- Email: fritz.sterr@th-deg.de
-
Contact:
- Julian Siepmann, M.Sc.
- Phone Number: +49-991-3615-8368
- Email: julian.siepmann@th-deg.de
-
Contact:
- Fritz Sterr, M.Sc.
-
Contact:
- Julian Siepmann, M.Sc.
-
Contact:
- Lydia Bauernfeind, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- German speaking
- Living in Austria, Germany or Switzerland
- Child loss during pregnancy or birth
- Child loss within last 12 months
- Legal capacity
- Voluntary participation
Exclusion Criteria:
- Loss of child after birth
- Not speaking and understanding German
- Not in a good mental condition to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parents after intrauterine or perinatal child loss
|
The investigators will conduct workshops with parents to get closer to the main topic.
The investigators will conduct focus group interviews with parents on their needs before and during child loss.
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.
The investigators will carry out a Delphi approach with parents to translate and confirm or revise the findings into treatment recommendations for healthcare professionals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During pregnancy and up to 7 days after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parents' subjective needs
Time Frame: During pregnancy and up to 7 days after birth
|
In qualitative interviews, the subjective needs that parents developed before and during their intrauterine or perinatal child loss will be investigated.
|
During pregnancy and up to 7 days after birth
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Christian Rester, Prof. Dr., Deggendorf Institute of Technology
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEHBa-202409-V-237-R2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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