# Prevalence of psychiatric disorders during pregnancy-a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol

Lucie Knabe, Camille Tanaka, Sarah Tebeka, Samantha Neilson, Clothilde Cauvin, Nicolas Mercier, Daphné Cayron, Morane Savelli, Philippe Deruelle, Florent Fuchs, et al.

► To cite this version:

Lucie Knabe, Camille Tanaka, Sarah Tebeka, Samantha Neilson, Clothilde Cauvin, et al. Prevalence of psychiatric disorders during pregnancy-a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol. BMJ Open, 2025, 15 (2), pp.e091923. 10.1136/bmjopen-2024-091923. hal-04978711

HAL Id: hal-04978711

https://hal.science/hal-04978711v1

Submitted on 5 Mar 2025

HAL is a multi-disciplinary open access
archive for the deposit and dissemination of sci-
entific research documents, whether they are pub-
lished or not. The documents may come from
teaching and research institutions in France or
abroad, or from public or private research centers.

L'archive ouverte pluridisciplinaire HAL, est
destinée au dépôt et à la diffusion de documents
scientifiques de niveau recherche, publiés ou non,
émanant des établissements d'enseignement et de
recherche français ou étrangers, des laboratoires
publics ou privés.

<figure><img src="image_1.png" /></figure>

Distributed under a Creative Commons Attribution 4.0 International License
# BMJ Open Prevalence of psychiatric disorders during pregnancy—a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol

Lucie Knabe<sup>1</sup>, Camille Tanaka,<sup>1</sup> Sarah Tebeka,<sup>2,3</sup> Samantha Neilson,<sup>4</sup> Clothilde Cauvin,<sup>1</sup> Nicolas Mercier,<sup>1</sup> Daphné Cayron,<sup>1</sup> Morane Savelli,<sup>5</sup> Philippe Deruelle,<sup>6</sup> Florent Fuchs,<sup>6,7,8</sup> Joana Pissarra,<sup>9</sup> Nicolas Molinari,<sup>10</sup> Raoul Belzeaux<sup>1,11</sup>

**To cite:** Knabe L, Tanaka C, Tebeka S, et al. Prevalence of psychiatric disorders during pregnancy—a feasibility study at second trimester ultrasound in the general population (GROUP study): study protocol. *BMJ Open* 2025;15:e091923. doi:10.1136/bmjopen-2024-091923

► Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-091923).

Received 01 August 2024
Accepted 22 January 2025

## ABSTRACT

**Introduction** During the perinatal period, women have an increased risk for psychiatric disorders, which are highly prevalent in this context. In addition, there are significant delays in diagnosing these conditions, worsening their prognosis and increasing their societal burden. Studies describing psychiatric disorders in the perinatal period often focus on specific disorders; only postpartum depression and, to a lesser extent, anxiety disorders are studied. There are also very few evaluations conducted by clinicians based on a semistructured interview, relying on the diagnostic criteria of international nosography.

**Methods and analysis** This multicentric prospective study will recruit 140 adult pregnant women based on randomly selected second trimester (T2) ultrasound consultations. The primary outcome is the prevalence of any psychiatric disorder assessed with a standardised psychiatric assessment, the Mini-International Neuropsychiatric Interview (M.I.N.I.). Within 10 days after the T2 ultrasound appointment, we will conduct the M.I.N.I., collect demographic data, evaluate suicidal behaviour with the Columbia-Suicide Severity Rating Scale, describe negative life events from the past year using the Paykel questionnaire and evaluation of social deprivation (Evaluation of the Deprivation and Inequalities of Health in Healthcare Centres score). Participants will also complete self-administered psychiatric questionnaires that screen for specific pathologies. We will build a biological sample collection. At two months post partum, we will repeat the questionnaires, adding an assessment of mother-child bonding. Patients can choose between in-person or telemedicine visits on both occasions.

**Ethics and dissemination** All participants will be required to provide written informed consent. The study has received ethical approval from the French National Committee ('Comité de Protection des Personnes Ouest VI') (approval number: 23.03919.000236). Results will be disseminated through peer-reviewed journal publications and at scientific conferences and meetings.

**Trial registration number** NCT06297252.

## STRENGTHS AND LIMITATIONS OF THIS STUDY

⇒ Uses a standardised diagnostic interview for diagnosing main psychiatric disorders, including suicide behaviours, ensuring validated and reproducible results.

⇒ Recruitment and analysis of 140 patients (number of subjects needed) in two distinct hospitals will allow for conclusions on the prevalence of psychiatric disorders.

⇒ Potential selection bias as women experiencing psychiatric symptoms may be more likely to participate in the study.

⇒ Establishes an innovative biobank.

## INTRODUCTION

Young women, particularly those between the ages of 15 and 25 years, are at a heightened risk for psychiatric disorders, which often first manifest during this period. These disorders are primarily identified in primary care and are typically managed by general practitioners, with psychiatrists intervening in severe or treatment-resistant cases. These psychiatric disorders represent a significant source of disability and healthcare costs and frequently coexist with several other psychiatric, addictive or non-psychiatric disorders,¹ potentially increasing suicidal behaviour.² Diagnosis delays are common, extending over several years, significantly worsening outcomes and escalating societal costs.³ Notably, the annual prevalence of psychiatric disorders among women is estimated to be at least 20%, including major depressive episodes (14%), bipolar disorder (3%), anxiety disorders (13%) and post-traumatic stress disorder (PTSD) (2%), some disorders

<figure><img src="image_2.png" /></figure>

Check for updates

© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.

For numbered affiliations see end of article.

**Correspondence to**
Dr Lucie Knabe;
l-knabe@chu-montpellier.fr
a

being associated with one one another.⁴ The perinatal
period—spanning pregnancy and the *postpartum* phase
up to 1 year after childbirth—marks a time of increased
psychiatric vulnerability. During this period, women are
at a higher risk of developing or exacerbating psychiatric
disorders. Accordingly, there is an increased risk of admis-
sion to a psychiatric hospital after childbirth.⁵,⁶ According
to a recent review of anxiety disorders, certain symptoms
specific to pregnancy have been identified as risk factors
for this pathology,⁷ including gestational vomiting and
sleep disorders. Perinatal depression is a common compli-
cation,⁸⁻¹⁰ with 16.7% of French women exhibiting symp-
toms of a major depressive episode 2 months post partum,
according to the latest National Perinatal Survey.¹¹ This is
very similar to the rates observed in other international
studies.¹² Also, 3% of women experience PTSD during
pregnancy, and 4% of women experience it during *post
partum*.¹³ Moreover, though rare, postpartum psychosis
also occurs.¹⁴ Lastly, death by suicide is the leading cause
of maternal mortality in several countries¹⁵: suicide is
responsible for around 20% of *postpartum* deaths.¹⁶

Disorders or symptoms that emerge during pregnancy often worsen in the *postpartum* period, significantly risking decompensation or recurrence.¹⁷⁻¹⁹ Also, untreated mental illness in pregnant women increases the risk of high-risk behaviours such as exposure to sexually transmitted diseases, smoking, alcohol and other substance use disorders, as well as inadequate prenatal care.²⁰ These disorders have an impact not only on the patient's quality of life but also on early interactions with the newborn.²¹ As a matter of fact, psychiatric disorders during the perinatal period may have a significant impact on fetal and infant development. The mother sets not only an intrauterine and postpartum environment, which can contribute to the child's psychopathology, but also typically plays a crucial role in shaping his emotional, social and cognitive development.²¹

Despite the intensive multidisciplinary monitoring
during the perinatal period, including consultations with
general practitioners, gynaecologists or midwives, and
comprehensive screening throughout pregnancy and
postpartum, psychiatric disorders remain largely underdi-
agnosed and undertreated.²² Clinical diagnosis in routine
practice lacks sensitivity in comparison with standardised
assessments,²³ ²⁴ such as the Mini-International Neuro-
psychiatric Interview (M.I.N.I.),²⁵ which is administered
by a psychiatric professional and provides a structured,
reproducible diagnostic approach, though it is more
time-consuming and costly.

Surprisingly, few studies have thoroughly investigated
the prevalence of all psychiatric disorders in a prospective
way during pregnancy using standardised and reliable
clinical assessments. Most research focused narrowly on
depression, neglecting the complex interplay of comorbid
conditions, including the relationship between PTSD and
depression, as well as undiagnosed bipolar disorders. One
significant American study²⁶ has used a validated semi-
structured questionnaire to assess all psychiatric disorders

among approximately 36000 pregnant women. In this
study, the prevalence of at least one psychiatric disorder
in the preceding year ranged from 33.7% among preg-
nant women with no obstetric complication to 40.1%
among those with obstetric complications. Also, Jacquelin
et al²⁷ used cross-sectional data from the National Epide-
miologic Survey on Alcohol and Related Conditions-III
to determine the prevalence of psychiatric disorders in
women with obstetric complications. The presence of
obstetric complications was associated with a significantly
higher prevalence of mood disorders and anxiety disor-
ders during the perinatal period compared with women
without obstetric complications.

The main strength of our study, compared with earlier
ones, is its innovative character. Two of these earlier
studies are quite similar but have major differences—
some of which may be considered weaknesses—that we
shall try not to reproduce. The first, published in 2003, is
a Swedish multicentric observational study. It was under-
taken to determine the prevalence of psychiatric disorders
during the second trimester (T2) of pregnancy.²⁸ To illus-
trate just how unsupported the literature is, the authors
described their work as a ‘probably unique study’. A vali-
dated semistructured questionnaire to assess psychiatric
disorders was completed by 1734 pregnant women who
had taken part in routine ultrasound screening. Psychi-
tric disorders were present in 14.1% of women. Major
depression was present in 3.3%, and anxiety disorders
in 6.6%. Only 5.5% received treatment. The second, a
Brazilian study conducted in 2013, was also observational.
It involved 239 women who benefited from M.I.N.I.
during their first-trimester ultrasound,²⁹ focusing on risk
factors associated with suicide. They demonstrated that
generalised anxiety disorder, major depressive disorder
and multiparity were associated with suicidal risk in the
first trimester of pregnancy.

These two studies provide us with epidemiological
data from geographical areas, and therefore, healthcare
systems differ from those in France. Our study, on the
other hand, will enable us to describe the landscape of
perinatal psychiatry, first locally and then nationally.

Another major strength of our protocol is that it
involves repeating the questionnaires at 2 months *post
partum*. Indeed, it is interesting to study the dynamics
of symptoms to identify elements that may be associated
with the development of pathology after pregnancy. For
example, Evans *et al*³⁰ noted an increase in depression
scores between the 18th and 32nd week of pregnancy, but
it is not clear whether this same phenomenon applies to
other psychiatric disorders.

The originality of our project also lies in the establish-
ment of a biological collection, which will serve as a foun-
dational resource for numerous future research projects.
These projects will focus on identifying novel biomarkers
not only in psychiatry and obstetrics but also across various
other disciplines. Emerging biomarkers offer hope for
enhancing diagnostic precision,³¹ ³² though their efficacy
requires further validation through replicated studies.
Thus, the aim of this study is to determine the prev-
alence of at least one diagnosed psychiatric disorder
(among all Diagnostic and Statistical Manual of Mental
Disorders-5 (DSM-5) diagnoses), whether in remission or
active, during pregnancy at the time of the T2 ultrasound.
We will evaluate the occurrence of psychiatric disorders
and the feasibility and acceptability of studying such
disorders in a general population of adult women with
ongoing pregnancies.

METHODS AND ANALYSIS

Study design and setting

This is an observational, prospective, multicentric study.
The study will be conducted in the gynaecology-obstetrics
departments of the Montpellier University Hospital and
Beziers Hospital. Briefly, these are the two main public
maternities in our region, performing over 3500 and
1000 births per year, respectively.

This study aims to include all pregnant women, regard-
less of comorbidities and other characteristics. Never-
theless, baseline characteristics will be used to classify
participants during analyses.

The choice to perform the first visit during the T2
ultrasound appointment was carefully considered. First,
this time period allows the detection of complications
arising during pregnancy: a first-trimester ultrasound
evaluation may not be able to identify disorders that
worsen or appear during pregnancy. Also, patient care
management is already welldefined in the T2 (women
have selected their obstetrics specialist, follow-up and
birth clinic).

A 2-month *postpartum* follow-up visit (V2) will allow for
assessing the evolution and consequences of the diagnoses
identified during the initial assessment. Previous studies
and national surveys screened for postpartum depres-
sion 2 months after delivery.33–36 Lastly, the 2-month V2
will also allow early detection of postpartum psychiatric

<figure><img src="image_3.png" /><figcaption>**Figure 1** Study flowchart detailing recruitment, inclusion/exclusion criteria and visits. GA, gestational age; T2, second trimester; V0, screening visit; V1, inclusion visit, V2, follow-up visit; V3, postpartum visit.</figcaption></figure>
<figure><img src="image_4.png" /></figure>

disorders, avoiding delays in treatment and, therefore, improving prognosis.

## Study population and eligibility criteria

Figure 1 shows the flowchart diagram of the study. Participants will be pregnant women undergoing a T2 ultrasound, regardless of known clinical history and normal or pathological pregnancy). Participants must meet the following inclusion criteria: female sex, legal adult, pregnant and scheduled for a T2 ultrasound and able to read and communicate in French (figure 1). Patients will not be included if they meet any of the following exclusion criteria: inability to understand French, illiteracy, minors at the time of the T2 ultrasound, under guardianship or curatorship, deprived of liberty, lacking social security coverage, refusal to consent after receiving information or currently participating in another research project with an ongoing exclusion period (figure 1). Participation is voluntary and participants can withdraw from the study at any time.

## Patient and Public Involvement

Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research.

## Recruitment and study timeline

The participant timeline is presented in figure 2. After recruitment, participants will undergo two visits within a 6-month follow-up period, including the final visit.

A total of 1250 volunteers will be approached to enrol approximately 140 participants. To limit sampling bias, the recruitment will involve a random selection of days for T2 ultrasound at the maternity units of Montpellier University Hospital and Beziers Hospital. On the randomly selected days, initial contact will be made between 28 and 21 days before the T2 ultrasound appointment, by email or post, with a brief presentation of the study. Patients will also be informed that a psychiatrist will contact them to present the study in greater detail and answer any questions they may have.

## Screening visit (V0)

A screening visit (V0) will be offered to all women scheduled for a T2 ultrasound on random preselected days. If they consent to participate, they will receive detailed study information. A V0 will be scheduled no later than 15 days before their ultrasound consultation. A psychiatrist will contact patients by telephone to introduce himself/herself and describe the study. The psychiatrist will answer

<figure><img src="image_5.png" /><figcaption>**Figure 2** Participant timeline and patient path. ¹Collected data: medical and socio-demographic characteristics, Evaluation of the Deprivation and Inequalities of Health in Healthcare Centres and Columbia-Suicide Severity Rating Scale questionnaire and Paykel inventory. ²Self-questionnaires: Edinburgh Postnatal Depression Scale, Mood Disorder Questionnaire, DSM-5 post-traumatic stress disorder checklist, Eating Disorder Examination Questionnaire, Medication Adherence Report Scale and Beliefs about Medicines Questionnaire. D, day; DSM-5, Diagnostic and Statistical Manual of Mental Disorders- 5; MIBS, Mother-to-Infant Bonding Scale; M.I.N.I., Mini-International Neuropsychiatric Interview; PAI, Personality Assessment Inventory and T2, second trimester; PP, postpartum; V0, screening visit; V1, inclusion visit, V2, follow-up visit; V3, postpartum visit.</figcaption></figure>
any questions participants may have and suggest considering taking part in the protocol. Following this call, the study information note will be sent to the participants. If they wish to have more information, or if they have agreed to the call by a psychiatrist, a few days after this initial contact, a clinical research associate will call patients back to provide more details about the study, particularly to enlighten them on practical aspects of their participation.

### Consent (inclusion visit (V1))

An inclusion visit (V1) will be scheduled on the day of their T2 ultrasound appointment. A psychiatrist will explain the study, answer any questions and ask the patient to sign a consent form (online supplemental file 1) if she wishes to participate. If, at this time, the patient expresses the wish not to participate in this research or not to be contacted about this project, solicitations will cease.

### Biological sample collection

If participants provide specific consent for the contribution to the biobank, a blood test will be conducted during the V1. The collection will include a 2.5 mL Paxgene tube for whole-blood RNA, a 6mL dry tube for serum and a 6mL EDTA tube for native DNA (retained for 5 years). These samples will be anonymised and sent to the Biological Resource Centre at Montpellier University Hospital.

### Follow-up visit (V2)

Follow-up visit (V2) will be scheduled at the hospital or via teleconsultation (videoconference or telephone) on the same day or within 10 days of the T2 ultrasound, based on the patient's preference, which will be noted. This session will primarily focus on completing the M.I.N.I. diagnostic interview with trained psychiatrists. To achieve a high inter-rater reliability, assuring a high degree of agreement, fewer than five examiners will be involved. They will also collect additional data such as medical and obstetrical history, expected pregnancy term and family medical history (standardised questionnaires and Electronic Case Report Form (e-CRF) (online supplemental file 2)). Given the epidemiological significance of suicide in the perinatal period, suicidal behaviour will be evaluated using the Columbia-Suicide Severity Rating Scale (CSSR-S).³⁷ The last 12 months' negative life events will be assessed using the Paykel questionnaire. Given its impact on psychological well-being, multiple dimensions of individual deprivation (eg, 'home-owning', 'financial difficulties' and 'sports activities') will be assessed using the Evaluation of the Deprivation and Inequalities of Health in Healthcare Centres (EPICES) questionnaire. Participants are required to complete self-administered questionnaires online on the same day or within 10 days: the Edinburgh Postnatal Depression Scale (EPDS)²⁴ for depression, the Mood Disorder Questionnaire (MDQ)³⁸ for bipolar disorder, the DSM-5 PTSD Checklist (PCL-5)³⁹ and the Eating Disorder Examination Questionnaire (EDEQ).⁴⁰ Additionally, the Beliefs about Medicines

Questionnaire (BMQ)⁴¹ and the Medication Adherence Report Scale (MARS)⁴² assess medication beliefs and adherence, respectively. The Personality Assessment Inventory (PAI)⁴³ evaluates mother-child bonding as the questionnaire is about the relationship between mother and unborn child.

Studies suggest that teleconsultation does not affect the quality of results compared with face-to-face interviews, supporting their equivalence.⁴⁴⁻⁴⁶

### Psychiatric medical history

Known psychiatric diagnoses will also be collected from the attending physician and the maternity records. Diagnoses explicitly recorded (eg, 'generalised anxiety disorder') and those inferred (eg, 'anxious patient') will be distinguished. This approach will highlight the discrepancies between unknown and newly established diagnoses, as identified using the M.I.N.I.

### Postpartum visit (V3)

The postpartum visit (V3) will occur in person or via teleconsultation around 2 months post partum (±2 weeks), aligned with the patient's preference and the expected delivery date, which may be reassessed by reviewing the patient's medical file at that time. During this visit, medical, obstetrical and paediatric information will be collected, a new M.I.N.I. assessment will be conducted and the initial self-questionnaires will be administered again, with the addition of the Mother-to-Infant Bonding Scale (MIBS)⁴⁷ to assess mother-child bonding, without the PAI.

### Outcomes and measures

The primary outcome is the presence of at least one psychiatric disorder of any kind (assessed by the M.I.N.I. questionnaire), in remission or not, during pregnancy at the T2 ultrasound.

Secondary outcomes at the two assessment stages (V2 and V3) include:

* The presence of each psychiatric disorder individually, including a history of suicidal behaviour disorder assessed with the CSSR-S. CSSR-S results will be interpreted according to each subsection's scores. If a positive score for questions 3 and 5 is observed, or if suicidal behaviour is confirmed, patients need immediate clinical intervention. If suicidal risk is present, the patient will need further evaluation and potential intervention. These interventions will be managed by our perinatal psychiatry team.

* The presence of postnatal depression assessed by the EPDS. The threshold for postpartum depression diagnosis will be an EPDS total score of over 13.

* The presence of bipolar disorders determined by the MDQ. The threshold for a bipolar disorder diagnosis will be at least 7 positive responses (out of 13 questions).

* The presence of PTSD determined by the PCL-5. Participants with a PCL-5 total score of at least 31 will be diagnosed with PTSD.
* The presence of eating disorders evaluated with the EDEQ. The cut-off to determine the presence of an eating disorder will be an EDEQ score of at least 4 (out of 6).

* The presence of diagnoses unknown to the obstetric team and/or not documented in the obstetric record.

* The presence of diagnoses unknown to the patient.

* The presence of diagnoses unknown to the attending physician.

* The presence of postpartum diagnoses.

* Medication compliance evaluated with the MARS. A MARS score of at least 6 (in 10) will indicate poor compliance.

* Beliefs about treatment assessed with the BMQ. The different BMQ subscores (all ranging from 1 to 5) will be used independently to interpret the participants' beliefs.

* Mother-child bond assessed by the MIBS and PAI. A disturbance in the mother-child bond will be detected if an MIBS total score is at least 2. PAI standardised scores ranging from 60 to 69 or 70 and above will indicate moderate or severe clinical disturbances, respectively.

* The sensitivity, specificity and positive and negative predictive values of the self-questionnaires (EPDS, MDQ, PCL-5 and EDEQ) compared with the gold standard (M.I.N.I.).

## Sample size

This study aims to estimate the prevalence of psychiatric disorders, anticipated to be around 20%. To achieve a precision of ±8% at 95% CI, 97 evaluable participants would be needed. Considering a potential 30% dropout rate, the target will be to enrol 140 participants.

## Data collection

During the visits V1 and V2, data will be collected based on the participants' declarations:

* Administrative and socio-demographic details such as marital status, residence, educational level, employment status and social security coverage, along with an evaluation of social deprivation (EPICES score).

* Medical history, including somatic, gynaecological and psychiatric conditions, associated treatments and substance use.

* Psychiatric family history among first-degree relatives.

* Current pregnancy data, including dates, gestational term, characteristics, follow-up and any obstetric complications.

* Clinical care characterisation, such as early prenatal interviews and support from perinatal professionals.

* Assessment of suicidal ideation and behaviour using the CSSR-S.

* Review of significant life events from the past 12 months using the Paykel inventory.

* Self-questionnaires cited above.

The data collected during visit V3 will be the following:

* Delivery and postpartum information.

* Newborn metrics such as weight, height, aspect (colouration), pulse, grimace (when excited), activity (tonus) and respiration score, previous hospitalisations and diagnoses.

* Data concerning the mother-child bond.

* Information on breastfeeding and feeding methods.

* Experiences related to care and childbirth.

* Self-questionnaires cited above.

## Data management

Data will be collected and recorded on e-CRF (online supplemental file 2) by trained local research coordinators or physicians. A REDCap-based electronic case report form will be used to gather and deposit patient data. For confidentiality purposes, participants will be identified with a unique identifier number, the name and family name initials, sex and age. If needed, source data will be made available for inspection purposes by the principal investigator.

Collected data should be: (1) correctly recorded in the e-CRF (online supplemental file 2) at the moment of collection; (2) pseudonymised and (3) validated by the principal investigator's electronic signature. All documents will be kept for the duration of the study in a secured physical location and a secured REDCap server until perennial archiving.

## Data analysis plan

The baseline features of the overall population and of each group will be described. Categorical variables will be reported as frequencies and percentages and continuous variables as either means with SD or medians with IQR.

The primary outcome and most secondary outcomes will be assessed with the M.I.N.I. questionnaire. Suicidal behaviour disorders will be evaluated with the CSSR-S questionnaire. The remaining secondary outcomes will be assessed using the scores of the self-questionnaires EPDS, MDQ, PCL-5, EDEQ, MARS and BMQ.

Participants' socio-demographic characteristics will be described using frequencies and percentages for qualitative variables or mean and SD or median and IQR, according to their distribution.

For the primary endpoint analysis, the prevalence of any psychiatric disorder during pregnancy will be described using frequencies, percentages and 95% CIs. For secondary endpoint analysis, specific disorders will be detailed similarly. The analysis will include subgroup evaluations based on known psychiatric histories. The diagnostic performance of self-administered questionnaires (EPDS, MDQ, PCL-5 and EDEQ) in identifying depression, mood disorders, PTSD and eating disorders, respectively, will be compared against the M.I.N.I. subdomains, with sensitivity, specificity and positive and negative predictive values computed along with 95% CIs.

Clustering methods will be applied to create homogeneous subgroups of participants based on comorbidities. No interim analysis is planned; preliminary data analysis will occur post-V2 completion, with comprehensive
analysis following the final V3. All analyses will be conducted by the medical statistical department of the Montpellier University Hospital using statistical software (SAS, V.9.4, SAS Institute and R, V.4.4.0).

## ETHICS AND DISSEMINATION

The project is part of the 'AOT TREMPLIN' initiative funded by the Montpellier University Hospital.

This research involving humans will be conducted in compliance with French 'Loi no 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine' (Loi Jardé), 'Loi No 78-17 du 6 janvier 1978 modifiée relative à l'Informatique, aux fichiers et aux Libertés'. This study will be conducted in accordance with Good Clinical Practice, as defined by the International Conference on Harmonisation. The study project has been approved by the ethics committee 'Comité de Protection des Personnes Ouest VI 23.03919.000236'. The study is conducted in accordance with the Declaration of Helsinki and was prospectively registered at ClinicalTrials.gov (NCT06297252) on 7 March 2024.

The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

### Author affiliations

**Contributors** LK, CT, ST, NMo and RB contributed to the conception and design of the study. LK and RB were involved in writing the manuscript. DC is the Clinical Research Associate. SN is the REDCap administrator. JP is the medical writer. ST and RB revised the manuscript by providing critical domain expertise. LK, CT, ST, SN, CC, NMe, MS, PD, FF, JP, NMo and RB contributed to the revision of the manuscript and approved the final version. RB is responsible for the overall content as guarantor.

**Funding** This work was supported by AOT TREMPLIN "RECHMPL23_0189", Montpellier University Hospital.

**Competing interests** None declared.

**Patient and public involvement** Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

**Patient consent for publication** Consent obtained directly from patient(s).

**Provenance and peer review** Not commissioned; externally peer reviewed.

**Supplemental material** This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those

of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

**Open access** This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

## ORCID iD

Lucie Knabe http://orcid.org/0000-0003-4560-4273

## REFERENCES

1. Icick R, Melle I, Etain B, et al. Preventive Medication Patterns in Bipolar Disorder and Their Relationship With Comorbid Substance Use Disorders in a Cross-National Observational Study. *Front Psychiatry* 2022;13:813256.

2. Lovero KL, Dos Santos PF, Come AX, et al. Suicide in Global Mental Health. *Curr Psychiatry Rep* 2023;25:255-62.

3. Christensen MK, Lim CCW, Saha S, et al. The cost of mental disorders: a systematic review. *Epidemiol Psychiatr Sci* 2020;29:e161.

4. Steel Z, Marnane C, Iranpour C, et al. The global prevalence of common mental disorders: a systematic review and meta-analysis 1980-2013. *Int J Epidemiol* 2014;43:476-93.

5. Bijma HH, Aaldriks AA, Knijff EM, et al. Acute psychiatric illness and drug addiction during pregnancy and the puerperium. *Handb Clin Neurol* 2020;172:125-44.

6. Kendell RE, Chalmers JC, Platz C. Epidemiology of Puerperal Psychoses. *Br J Psychiatry* 1987;150:662-73.

7. Furtado M, Chow CHT, Owais S, et al. Risk factors of new onset anxiety and anxiety exacerbation in the perinatal period: A systematic review and meta-analysis. *J Affect Disord* 2018;238:626-35.

8. França UL, McManus ML. Frequency, trends, and antecedents of severe maternal depression after three million U.S. births. *PLoS One* 2018;13:e0192854.

9. Fond G, Lancon C, Auquier P, et al. Prévalence de la dépression majeure en France en population générale et en populations spécifiques de 2000 à 2018 : une revue systématique de la littérature. *La Presse Médicale* 2019;48:365-75.

10. Gavin NI, Gaynes BN, Lohr KN, et al. Perinatal depression: a systematic review of prevalence and incidence. *Obstet Gynecol* 2005;106:1071-83.

11. Le Ray C, Lelong N, Cinelli H, et al. Results of the 2021 French National Perinatal Survey and trends in perinatal health in metropolitan France since 1995. *J Gynecol Obstet Hum Reprod* 2022;51:S2468-7847(22)00191-X.

12. Woody CA, Ferrari AJ, Siskind DJ, et al. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. *J Affect Disord* 2017;219:86-92.

13. Cook N, Ayers S, Horsch A. Maternal posttraumatic stress disorder during the perinatal period and child outcomes: A systematic review. *J Affect Disord* 2018;225:18-31.

14. Michalczyk J, Miłosz A, Soroka E. Postpartum Psychosis: A Review of Risk Factors, Clinical Picture, Management, Prevention, and Psychosocial Determinants. *Med Sci Monit* 2023;29:e942520.

15. Saucedo M, Deneux-Tharaux C. Mortalité maternelle en France, 2016-2018, fréquence, causes et profil des femmes. *Gynécologie Obstétrique Fertilité & Sénologie* 2024;52:185-200.

16. Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. *Arch Womens Ment Health* 2005;8:77-87.

17. Wallwiener S, Goetz M, Lanfer A, et al. Epidemiology of mental disorders during pregnancy and link to birth outcome: a large-scale retrospective observational database study including 38,000 pregnancies. *Arch Gynecol Obstet* 2019;299:755-63.

18. Viguera AC, Tondo L, Koukopoulos AE, et al. Episodes of mood disorders in 2,252 pregnancies and postpartum periods. *Am J Psychiatry* 2011;168:1179-85.

19. Biaggi A, Conroy S, Pawlby S, et al. Identifying the women at risk of antenatal anxiety and depression: A systematic review. *J Affect Disord* 2016;191:62-77.

<footnote n="1">¹Department of Psychiatry and Addictology, University Hospital Center, Montpellier, France</footnote>

<footnote n="2">²Université Paris Cité, INSERM UMR1266, Institute of Psychiatry and neurosciences, Team 1, Paris, France</footnote>

<footnote n="3">³Department of Psychiatry, AP-HP, Louis Mourier Hospital, Colombes, France</footnote>

<footnote n="4">⁴INT-UMR 7289, CNRS Aix-Marseille University, Marseille, France</footnote>

<footnote n="5">⁵Clinical Research Unit, CH Beziers, Beziers, France</footnote>

<footnote n="6">⁶Department of Obstetrics and Gynecology, University Hospital Center, Montpellier, France</footnote>

<footnote n="7">⁷INSERM, Center for research in Epidemiology and Population Health, U1018, Reproduction and Child Development, Villejuif, France</footnote>

<footnote n="8">⁸Desbrest Institute of Epidemiology and Public Health (IDESP), INSERM, Montpellier, France</footnote>

<footnote n="9">⁹Clinical Research and Epidemiology Unit, University Hospital Center, Montpellier, France</footnote>

<footnote n="10">¹⁰IDESP, INSERM, PreMEDical INRIA, University Hospital Center, Montpellier, France</footnote>

<footnote n="11">¹¹IGF, CNRS, INSERM, Montpellier, France</footnote>
20 Abdelhafez MA, Ahmed KM, Ahmed NM, et al. Psychiatric illness and pregnancy: A literature review. *Heliyon* 2023;9:e20958.

21 Leight KL, Fitelson EM, Weston CA, et al. Childbirth and mental disorders. *Int Rev Psychiatry* 2010;22:453-71.

22 Faisal-Cury A, Rodrigues DMO, Matijasevich A. Are pregnant women at higher risk of depression underdiagnosis? *J Affect Disord* 2021;283:192-7.

23 Negeri ZF, Levis B, Sun Y, et al. Accuracy of the Patient Health Questionnaire-9 for screening to detect major depression: updated systematic review and individual participant data meta-analysis. *BMJ* 2021;375:n2183.

24 Levis B, Negeri Z, Sun Y, et al. Accuracy of the Edinburgh Postnatal Depression Scale (EPDS) for screening to detect major depression among pregnant and postpartum women: systematic review and meta-analysis of individual participant data. *BMJ* 2020;371:m4022.

25 Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. *J Clin Psychiatry* 1998;59 Suppl 20:22-33;

26 Sommer JL, Shamblaw A, Mota N, et al. Mental disorders during the perinatal period: Results from a nationally representative study. *Gen Hosp Psychiatry* 2021;73:71-7.

27 Jacquelin M, Dubertret C, Ngameni EG, et al. Prevalence of Psychiatric Disorders in Women With Obstetric Complications: Results From the National Epidemiologic Survey on Alcohol and Related Conditions-III. *J Clin Psychiatry* 2024;85:231-1569.

28 Andersson L, Sundström-Poromaa I, Bixo M, et al. Point prevalence of psychiatric disorders during the second trimester of pregnancy: a population-based study. *Am J Obstet Gynecol* 2003;189:148-54.

29 Farias DR, Pinto T de JP, Teofilo MMA, et al. Prevalence of psychiatric disorders in the first trimester of pregnancy and factors associated with current suicide risk. *Psychiatry Res* 2013;210:962-8.

30 Evans J, Heron J, Francomb H, et al. Cohort study of depressed mood during pregnancy and after childbirth. *BMJ* 2001;323:257-60.

31 Belzeaux R, Gorgievski V, Fiori LM, et al. GPR56/ADGRG1 is associated with response to antidepressant treatment. *Nat Commun* 2020;11:1635.

32 Tebeka S, Gloaguen E, Mullaert J, et al. Genome-wide association study of early-onset and late-onset postpartum depression: the IGEDEPP prospective study. *Eur Psychiatry* 2024;67:1-36.

33 Tebeka S, Le Strat Y, De Premorel Higgons A, et al. Prevalence and incidence of postpartum depression and environmental factors: The IGEDEPP cohort. *J Psychiatr Res* 2021;138:366-74.

34 Nonacs R, Cohen LS. Postpartum mood disorders: diagnosis and treatment guidelines. *J Clin Psychiatry* 1998;59 Suppl 2:34-40.

35 Sit DKY, Wisner KL. Identification of postpartum depression. *Clin Obstet Gynecol* 2009;52:456-68.

36 Munk-Olsen T, Laursen TM, Mendelson T, et al. Risks and predictors of readmission for a mental disorder during the postpartum period. *Arch Gen Psychiatry* 2009;66:189-95.

37 Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. *Am J Psychiatry* 2011;168:1266-77.

38 Hirschfeld RMA, Williams JBW, Spitzer RL, et al. Development and Validation of a Screening Instrument for Bipolar Spectrum Disorder: The Mood Disorder Questionnaire. *AJP* 2000;157:1873-5.

39 U.S. Department of Veterans Affairs. National Center for PTSD, Available: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp#obtain

40 Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? *Int J Eat Disord* 1994;16:363-70.

41 Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. *Psychol Health* 1999;14:1-24.

42 Horne R, Weinman J. Self-regulation and Self-management in Asthma: Exploring The Role of Illness Perceptions and Treatment Beliefs in Explaining Non-adherence to Preventer Medication. *Psychol Health* 2002;17:17-32.

43 Jurgens MA, Levy-Rueff M, Goffinet F, et al. Étude des propriétés psychométriques d'une échelle d'attachement prénatal. Version française de la Prenatal Attachment Inventory (PAI, Müller, 1993). *L'Encéphale* 2010;36:219-25.

44 Kobak KA. A comparison of face-to-face and videoconference administration of the Hamilton Depression Rating Scale. *J Telemed Telecare* 2004;10:231-5.

45 Yung HY, Yeung WT, Law CW. The reliability of symptom assessment by telepsychiatry compared with face to face psychiatric interviews. *Psychiatry Res* 2022;316:S0165-1781(22)00323-7.

46 Shore JH, Savin D, Orton H, et al. Diagnostic Reliability of Telepsychiatry in American Indian Veterans. *Am J Psychiatry* 2007;164:115.

47 Bienfait M, Haquet A, Maury M, et al. Traduction française de l'autoquestionnaire MIBS (Mother to Infant Bonding Scale) et validation comme évaluation du lien mère-nouveau-né en maternité. *Devenir* 2017;29:233-53.