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

October 29, 2026 updated by: Hôpital NOVO

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 informed consent form
  6. Sufficient proficiency in French to participate in an interview
  7. Consent given for the audio recording of the interview

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Pregnant woman

Pregnant woman with a history of perinatal loss
Other: Semi-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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Experience of medical examinations
Time Frame: 8 months

Response from the semi-structured interview
8 months
Analysis of the place accorded to the deceased child
Time Frame: 8 months

Response from the semi-structured interview
8 months
Feelings toward the medical profession
Time Frame: 8 months

Response from the semi-structured interview
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital NOVO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-A01510-51
  • CHRD0726 (Other Identifier: HOSPITAL NOVO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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