- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07915674
When Death Is Present at Birth: Women's Experiences During Pregnancy (GADP)
When Death Is Present at Birth: Women's Experiences During Pregnancy Following Perinatal Bereavement, Psychological Adjustment, and Attachment Issues
Current scientific literature confirms that pregnancy following perinatal bereavement is a period of significant psychological vulnerability. Quantitative research highlights a high prevalence of anxiety disorders, depressive symptoms, and post-traumatic stress among these mothers. However, there is a significant gap between somatic medical monitoring-which has become highly effective-and an understanding of these women's subjective experiences. Data regarding the restructuring of prenatal attachment and "psychic transparency" in this context of traumatic aftermath remain extremely scarce. The purpose of this research is therefore to fill this gap by exploring, through a phenomenological approach, how the bond with the unborn child is formed when death occurred during the previous birth.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The originality of this research resides in its paradigm shift. It changes the focus from pathology (trauma as a disorder) to the phenomenology of the bond (the experience of attachment). While the majority of available studies on perinatal bereavement are quantitative in nature and focused on measuring psychological distress, this study offers a rare and deeply qualitative exploration of the "pregnancy that follows." Its innovative nature stems from the use of Interpretive Phenomenological Analysis (IPA), a methodology that has yet to be widely applied to this specific topic in France. This approach allows for a nuanced understanding of the psychological shifts and the uniqueness of "psychic transparency" among these women, where traditional measurement scales fail to capture the complexity of their lived experience.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pontoise, Francia, 95303
- Hôpital NOVO
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Contatto:
- Aurelie BARIAN
- Numero di telefono: 01 30 75 57 76
- Email: aurelie.barian@ght-novo.fr
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Contatto:
- Emma DECHAUX
- Numero di telefono: 01 30 75 57 76
- Email: emma.dechaux@psycho-prat.fr
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Investigatore principale:
- Aurelie BARIAN
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Women aged 18 or older
- Medically confirmed ongoing pregnancy: at least 14 weeks of amenorrhea (SA), or at least 12 weeks of gestation,
- Receiving psychological counseling during the current pregnancy
- History of a perinatal loss as defined by the WHO (between 22 weeks of amenorrhea (SA) and the 7th day of life) during a previous pregnancy
- Ability to understand the information and sign an informed consent form
- Sufficient proficiency in French to participate in an interview
- Consent given for the audio recording of the interview
Exclusion Criteria:
- Serious obstetric complications in the current pregnancy (severe threat of preterm labor requiring hospitalization, preeclampsia, severe intrauterine growth restriction) or any maternal/fetal condition that is life-threatening in the short term.
- Severe or unstable psychiatric disorders (psychotic disorder) that may impair judgment or pose a risk of decompensation.
- A full-blown depressive episode or an ongoing suicidal crisis.
- A patient under guardianship, conservatorship, or judicial protection.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Pregnant woman
Pregnant woman with a history of perinatal loss |
The semi-structured interview (single visit) is conducted immediately after enrollment, either before or after a scheduled visit as part of routine prenatal care. Lasting approximately 45 minutes, it is securely recorded. The "data collection" focuses exclusively on verbal data gathered during a semi-structured clinical interview. This data is collected via a digital audio recording, which is necessary for the accurate transcription of the speech for phenomenological analysis (IPA). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Nature and quality of the prenatal attachment
Lasso di tempo: 8 months
|
The primary assessment criteria collected during the semi-structured interview involve analyzing the nature and quality of the prenatal attachment bond (psychic investment). The purpose is to evaluate whether the attachment bond is formed with flexibility or is hindered by fear, by exploring the balance between the imaginary child and the fantasized child. |
8 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Experience of medical examinations
Lasso di tempo: 8 months
|
Response from the semi-structured interview |
8 months
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Analysis of the place accorded to the deceased child
Lasso di tempo: 8 months
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Response from the semi-structured interview |
8 months
|
|
Feelings toward the medical profession
Lasso di tempo: 8 months
|
Response from the semi-structured interview |
8 months
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-A01510-51
- CHRD0726 (Altro identificatore: HOSPITAL NOVO)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .