Perinatal DepressionNCT06473935
Maternal Well-being in the Perinatal Period
An observational study of Perinatal Depression and Anxiety, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Depression, Anxiety, Loneliness
- What is being tested?
- Questionnaires and focus groups
- How many people
- 134 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Child, Adult, Older adult
Study population: We plan to recruit a sample of at least 134 patients. This sample size allows us to meet the recommendations obtained from conducting the power analysis. The sample size calculation was performed using G*Power software (version 3.1.9.6, Faul et al., 2007).
Who may be able to join
- Age 18 years or older
- Adequate understanding of the Italian language
- Willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
- Women experiencing their first pregnancy
- Women in the last trimester of gestation (28th-35th week of gestation) who will be followed for 18 months after childbirth
Who cannot join
- Age under 18 years old
- Women who are not able to understand the Italian language
- Absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
- Women who are not experiencing their first pregnancy
- Women who are not in the last trimester of gestation (28th-35th week of gestation)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, 20132
Valentina Di Mattei, Professor
About this study
Official title: Maternal Well-being in the Perinatal Period: a Prospective Observational Study
The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.
Read the detailed description
The primary goal of this observational study si to investigate the mental health status of women experiencing their first pregnancy, with particular attention to manifestations of anxiety and depression, feelings of loneliness, and the quality of defense mechanisms employed, during the last trimester of gestation (28th-35th week of gestation) and over the course of the 18 months following the child's birth.
Furthermore, the study aims to conduct an in-depth analysis of the variables associated with the psychological adaptation of women during the perinatal period, with particular reference to the following exploratory objectives:
- To explore the association between the investigated psychological dimensions and the quality of the bond with the child in the prenatal and postnatal periods.
- To identify any significant differences in the variables of interest between women who conceived naturally and those who underwent assisted reproductive technology (ART).
- To detect, through qualitative methods (semi-structured interviews and focus groups), the unmet needs of women during the perinatal period, as well as their preferences and expectations regarding the nature of desirable support interventions during this period. This would enable the construction and provision of an intervention model that closely aligns with the specific needs of this patient population.
The collected data will allow for the identification of individuals at higher risk of psychological distress and adaptation problems during the perinatal period, as well as potential impairment in the quality of the attachment bond with the child.
- Conditions
- Perinatal Depression, Anxiety, Loneliness, Mother-Child Relations
- Being tested
- Questionnaires and focus groups
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and focus groupsOther
Participation in the research involves completing a test battery composed of self-administered questionnaires, all validated in the Italian language.
Additionally, qualitative data will be collected through semi-structured interviews (conducted in person or online, based on individual preferences) and focus groups, both lasting between 90 and 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Women during pregnancy and postpartum | Women during the last trimester of gestation (28th-35th week of gestation) and during the 18 months following the child's birth Receives: Other: Questionnaires and focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Levels of perinatal depression and of pregnancy-related anxiety
Measured: June 1, 2024 - December 31, 2025
Anxiety
Levels of state and trait anxiety
Measured: June 1, 2024 - December 31, 2025
Loneliness
Feelings of loneliness during and after pregnancy
Measured: June 1, 2024 - December 31, 2025
Defense mechanisms
Nature of defense mechanisms during and after pregnancy
Measured: June 1, 2024 - December 31, 2025
Secondary outcomes (3)
Attachment bond
Quality of prenatal of attachment bond and in the postpartum period
Measured: June 1, 2024 - December 31, 2025
Women subjective experience
Subjective experience of pregnancy and postpartum
Measured: June 1, 2024 - December 31, 2025
Unmet needs of women
Unmet needs of women during the perinatal period
Measured: June 1, 2024 - December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jun 2024
- Primary completion15 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Di Mattei, IRCCS San Raffaele
- Investigators
- Valentina Di Mattei, Professor, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473935
- Sponsor's protocol ID
- Benessere Materno23
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Well-being in the Perinatal Period: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06473935
- Acronym / sponsor ID
- Benessere Materno23
- Conditions
- Perinatal Depression, Anxiety, Loneliness, Mother-Child Relations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.
Detailed description
The primary goal of this observational study si to investigate the mental health status of women experiencing their first pregnancy, with particular attention to manifestations of anxiety and depression, feelings of loneliness, and the quality of defense mechanisms employed, during the last trimester of gestation (28th-35th week of gestation) and over the course of the 18 months following the child's birth.
Furthermore, the study aims to conduct an in-depth analysis of the variables associated with the psychological adaptation of women during the perinatal period, with particular reference to the following exploratory objectives:
- To explore the association between the investigated psychological dimensions and the quality of the bond with the child in the prenatal and postnatal periods.
- To identify any significant differences in the variables of interest between women who conceived naturally and those who underwent assisted reproductive technology (ART).
- To detect, through qualitative methods (semi-structured interviews and focus groups), the unmet needs of women during the perinatal period, as well as their preferences and expectations regarding the nature of desirable support interventions during this period. This would enable the construction and provision of an intervention model that closely aligns with the specific needs of this patient population.
The collected data will allow for the identification of individuals at higher risk of psychological distress and adaptation problems during the perinatal period, as well as potential impairment in the quality of the attachment bond with the child.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women during pregnancy and postpartum | – | Other: Questionnaires and focus groupsWomen during the last trimester of gestation (28th-35th week of gestation) and during the 18 months following the child's birth |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- We plan to recruit a sample of at least 134 patients. This sample size allows us to meet the recommendations obtained from conducting the power analysis. The sample size calculation was performed using G*Power software (version 3.1.9.6, Faul et al., 2007).
Key inclusion criteria (5 listed)
- Age 18 years or older
- Adequate understanding of the Italian language
- Willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
- Women experiencing their first pregnancy
- Women in the last trimester of gestation (28th-35th week of gestation) who will be followed for 18 months after childbirth
Key exclusion criteria (5 listed)
- Age under 18 years old
- Women who are not able to understand the Italian language
- Absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
- Women who are not experiencing their first pregnancy
- Women who are not in the last trimester of gestation (28th-35th week of gestation)
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 |
|---|---|---|
| Questionnaires and focus groupsParticipation in the research involves completing a test battery composed of self-administered questionnaires, all validated in the Italian language. Additionally, qualitative data will be collected through semi-structured interviews (conducted in person or online, based on individual preferences) and focus groups, both lasting between 90 and 120 minutes. | Other | Women during pregnancy and postpartum |
Primary outcome
Depression
Time frame: June 1, 2024 - December 31, 2025
Levels of perinatal depression and of pregnancy-related anxiety
Anxiety
Time frame: June 1, 2024 - December 31, 2025
Levels of state and trait anxiety
Loneliness
Time frame: June 1, 2024 - December 31, 2025
Feelings of loneliness during and after pregnancy
Defense mechanisms
Time frame: June 1, 2024 - December 31, 2025
Nature of defense mechanisms during and after pregnancy
3 secondary outcomes
Attachment bond
Time frame: June 1, 2024 - December 31, 2025
Women subjective experience
Time frame: June 1, 2024 - December 31, 2025
Unmet needs of women
Time frame: June 1, 2024 - December 31, 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
Related trials for Perinatal Depression
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
Improving Perinatal Mental Health Through a Collaborative, Community Health Worker and Social Worker Intervention
Perinatal Anxiety, Perinatal Depression
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. This study is not recruiting at the moment.
Valentina Di Mattei, Professor principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Depression and Anxiety, run by IRCCS San Raffaele at 1 site in Italy.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Di Mattei, Professor (0226435829, dimattei.valentina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: June 1, 2024 - December 31, 2025). The study lists 4 primary outcomes in all. 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 25 Jun 2024.