ClinicalTrials.gg
Not yet recruitingNCT07915674GADPUpdated Nov 4, 2026

When Death Is Present at Birth: Women's Experiences During Pregnancy

An interventional study of Semi-structured interview in Pregnancy, sponsored by Hôpital NOVO. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Hôpital NOVO · Not applicable, Interventional, and Other

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pregnancy

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Keywords

  • Perinatal death
  • Legal and symbolic recognition
  • Expected child
03

In context

Perinatal Death

120 studies on the registry are indexed under Perinatal Death; 25 are open to participants now.

This study's planned enrollment of 10 is below the median of 427 across 84 interventional studies indexed under Perinatal Death.

Browse Perinatal Death studies →

Lead sponsor

Hôpital NOVO is the lead sponsor of 70 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women aged 18 or older
  2. Medically confirmed ongoing pregnancy: at least 14 weeks of amenorrhea (SA), or at least 12 weeks of gestation,
  3. Receiving psychological counseling during the current pregnancy
  4. 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
  5. Ability to understand the information and sign an form
  6. Sufficient proficiency in French to participate in an interview
  7. Consent given for the audio recording of the interview

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Severe or unstable psychiatric disorders (psychotic disorder) that may impair judgment or pose a risk of decompensation.
  3. A full-blown depressive episode or an ongoing suicidal crisis.
  4. A patient under guardianship, conservatorship, or judicial protection.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    Pregnant woman

    Pregnant woman with a history of perinatal loss

    Other: Semi-structured interview

Interventions

  • OtherSemi-structured interview

    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).

06

What researchers measure

Primary outcomes

  1. Nature and quality of the prenatal attachment

    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.

    Time frame: 8 months

Secondary outcomes

  1. Experience of medical examinations

    Response from the semi-structured interview

    Time frame: 8 months

  2. Analysis of the place accorded to the deceased child

    Response from the semi-structured interview

    Time frame: 8 months

  3. Feelings toward the medical profession

    Response from the semi-structured interview

    Time frame: 8 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07915674
Lead sponsor
Hôpital NOVO
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Jun 2, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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