PregnancyGADPNCT07915674
When Death Is Present at Birth: Women's Experiences During Pregnancy
A study testing Semi-structured interview in people with Pregnancy, run by Hôpital NOVO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Semi-structured interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital NOVO
Pontoise, 95303
Aurelie BARIAN, 01 30 75 57 76, aurelie.barian@ght-novo.fr
Emma DECHAUX, 01 30 75 57 76, emma.dechaux@psycho-prat.fr
About this study
Official title: 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.
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.
- Conditions
- Pregnancy
- Being tested
- Semi-structured interview
- Keywords
- Perinatal death, Legal and symbolic recognition, Expected child
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Pregnant woman | Other | Pregnant woman with a history of perinatal loss Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (3)
Experience of medical examinations
Response from the semi-structured interview
Measured: 8 months
Analysis of the place accorded to the deceased child
Response from the semi-structured interview
Measured: 8 months
Feelings toward the medical profession
Response from the semi-structured interview
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915674
- Sponsor's protocol ID
- 2026-A01510-51
- Other IDs
- CHRD0726
- Acronym
- GADP
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Death Is Present at Birth: Women's Experiences During Pregnancy Following Perinatal Bereavement, Psychological Adjustment, and Attachment Issues
- ClinicalTrials.gov ID
- NCT07915674
- Acronym / sponsor ID
- GADP / 2026-A01510-51
- Conditions
- Pregnancy
- Keywords
- Perinatal death, Legal and symbolic recognition, Expected child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant woman | Other | Other: Semi-structured interviewPregnant woman with a history of perinatal loss |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Semi-structured interviewThe 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). | Other | Pregnant woman |
Primary outcome
Nature and quality of the prenatal attachment
Time frame: 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.
3 secondary outcomes
Experience of medical examinations
Time frame: 8 months
Analysis of the place accorded to the deceased child
Time frame: 8 months
Feelings toward the medical profession
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview in people with Pregnancy, run by Hôpital NOVO at 1 site in France.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and quality of the prenatal attachment (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.