The Effects of Extreme Prematurity on Parenting
NCT07918365, Not yet recruiting, Centre Hospitalier Universitaire de Besancon
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Effects of Extreme Prematurity on Parenting | ClinicalTrials.gov |
| NCT number | NCT07918365 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre Hospitalier Universitaire de Besancon | ClinicalTrials.gov |
| Conditions | Depression Disorder, Post Traumatic Stress Disorder PTSD | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Childbirth related post-traumatic stress disorder | November 2026 to May 2027 | The City Birth Trauma Scale (City BiTS) is a self-report questionnaire assessing childbirth-related post-traumatic stress symptoms according to DSM-5 criteria. It explores traumatic exposure, re-experiencing, avoidance, negative cognitions and mood, hyperarousal, symptom duration, distress, and functional impairment. Its 20 symptom items are scored from 0 to 3, yielding a total symptom score ranging from 0 to 60, with higher scores indicating greater symptom severity. In this study, the French versions for mothers and partners will be administered following very preterm birth. Total symptom scores will be analysed as a continuous measure. The questionnaire does not independently establish a clinical diagnosis of post-traumatic stress disorder. | ClinicalTrials.gov |
| Secondary | Postnatal Depression | November 2026 to May 2027 | The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire assessing depressive symptoms over the past seven days. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 30, with higher scores indicating greater symptom severity. It includes an item assessing thoughts of self-harm. In this study, the French version will be administered to mothers and fathers following very preterm birth to assess parental depressive symptoms. Total scores will be analysed as a continuous measure. The EPDS is a screening instrument and does not establish a clinical diagnosis of depression. | ClinicalTrials.gov |
| Other | Parental psychological functioning assessed using the Rorschach test | November 2026 to May 2027 | The Rorschach test is a projective psychological assessment comprising 10 standardized inkblot cards. Participants describe what each inkblot might represent, followed by an inquiry to clarify their responses. Responses are coded and interpreted according to the French School (Paris School) approach, considering perceptual features, response content, and qualitative aspects of the protocol. In this study, it will be used to explore parental psychological functioning, with particular attention to emotional processing, defensive processes, and psychic boundaries in the context of very preterm birth. Findings will contribute to an exploratory assessment of psychological containment, protection, and differentiation. No single overall score or diagnostic cutoff will be used. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)