NCT06771661

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 2, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

December 19, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

Pregnancy lossChild lossQualitative researchMixed-methodsExperienceNeedParentsPerinatal lossFetal deathMiscarriageStillbirth

Outcome Measures

Primary Outcomes (1)

  • Parent's experience

    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 Outcomes (1)

  • Parents' subjective needs

    During pregnancy and up to 7 days after birth

Study Arms (1)

Parents after intrauterine or perinatal child loss

Other: WorkshopsOther: Focus group interviewsOther: Narrative interviewsOther: Delphi approach

Interventions

The investigators will conduct workshops with parents to get closer to the main topic.

Parents after intrauterine or perinatal child loss

The investigators will conduct focus group interviews with parents on their needs before and during child loss.

Parents after intrauterine or perinatal 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.

Parents after 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.

Parents after intrauterine or perinatal child loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parents (mothers, fathers) will be recruited that lost their child during pregnancy or birth in hospitals, at home or birth houses.

You may qualify if:

  • German speaking
  • Living in Austria, Germany or Switzerland
  • Child loss during pregnancy or birth
  • Child loss within last 12 months
  • Legal capacity
  • Voluntary participation

You may not qualify if:

  • Loss of child after birth
  • Not speaking and understanding German
  • Not in a good mental condition to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences

Deggendorf, Bavaria, 94469, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

StillbirthFetal DeathAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Rester, Prof. Dr.

    Deggendorf Institute of Technology

    STUDY CHAIR

Central Study Contacts

Julian Siepmann, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research associate

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 13, 2025

Study Start

December 2, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations