PregnancyComPARENCT07919145
Effective Communication in Perinatal Care
An observational study of Pregnancy and Vbac, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
ComPARE is a cross-sectional observational study investigating the effectiveness of communication during prenatal consultations concerning vaginal birth after caesarean (VBAC). It involves 50 pregnant people considering VBAC and 12 healthcare professionals from IRCCS Ospedale San Raffaele: 6 OB-GYNs and 6 midwives… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 16 Sep 2026to 16 Sep 2031
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will consist of approximately 50 pregnant participants with a history of previous caesarean delivery who are considering vaginal birth after caesarean (VBAC). Participants will be recruited among patients attending prenatal counselling consultations at IRCCS Ospedale San Raffaele, Milan, Italy. Eligible participants will be between 18 and 44 years of age, have a singleton pregnancy between 33 and 37 weeks of gestation, and be planning delivery at the study hospital. The study will examine communicative misunderstandings during prenatal counselling and patients' perceptions of the information exchanged.
Who may be able to join
- Singleton pregnancy.
- Gestational age between 33 and 37 weeks at the time of the prenatal consultation.
- Maternal age between 18 and 44 years, inclusive.
- Ability to communicate in Italian and understand the study procedures.
- History of at least one previous caesarean delivery.
- Planned delivery at IRCCS Ospedale San Raffaele.
- Provision of written informed consent for study participation and audio recording of the consultation.
Who cannot join
- Multiple pregnancy.
- Obstetric emergencies or urgent clinical conditions requiring immediate medical intervention that would prevent the planned prenatal counselling consultation.
- Inability to provide valid informed consent.
- Refusal of audio recording of the consultation.
- Clinical or logistical circumstances preventing participation in the interview following the consultation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Massimo Candiani, Professor, +39 02 2643 2653, candiani.massimo@hsr.it
Mara Floris, PhD, floris.mara@unisr.it
About this study
Official title: ComPARE: Effective COMmunication in Perinatal cARE Cross-sectional Study
ComPARE is a cross-sectional observational study investigating the effectiveness of communication during prenatal consultations concerning vaginal birth after caesarean (VBAC). It involves 50 pregnant people considering VBAC and 12 healthcare professionals from IRCCS Ospedale San Raffaele: 6 OB-GYNs and 6 midwives with expertise in VBAC. The main objective is to identify and analyse misunderstandings in doctor/midwife-patient communication, using the TouCAN Codebook, and to examine whether these misunderstandings are associated with patients' perceptions of communication quality. The study does not introduce any treatment or medical device: it analyses routine clinical consultations. The study period is 5 years, with 2 years of enrolment.
Read the detailed description
ComPARE (effective COMmunication in Perinatal cARE) is a cross-sectional observational study investigating the clarity, accessibility, and effectiveness of communication between healthcare professionals and pregnant individuals during prenatal consultations concerning vaginal birth after caesarean (VBAC).
Doctor-patient communication is an integral component of clinical care and is essential for establishing trust, supporting patient autonomy and shared decision-making, and promoting patient safety and quality of care. In clinical communication, misunderstandings may arise not only from the explicit content of what is said, but also from implicit assumptions, contextual cues, presuppositions, and non-literal meanings. The TouCAN Codebook (Textual misUnderstanding Codebook ANalysis) provides a structured linguistic framework for identifying markers of potentially problematic communication that may hinder mutual understanding. The present study applies this approach to perinatal care, with a specific focus on consultations concerning VBAC.
The study addresses the need for research specifically examining communication practices in VBAC counselling. These consultations involve the communication of complex and risk-sensitive information concerning pregnancy and birth and require information to be conveyed in a clear and accessible manner to support informed and autonomous decision-making.
The study population consists of 50 pregnant individuals considering VBAC and 12 healthcare professionals from IRCCS Ospedale San Raffaele, including 6 obstetricians and gynaecologists (OB-GYNs) and 6 midwives with expertise in VBAC. Eligible pregnant participants are Italian-speaking individuals aged 18-44 years with a singleton pregnancy between 33 and 37 weeks of gestation, a history of caesarean section in a previous pregnancy, and a scheduled VBAC counselling consultation at IRCCS Ospedale San Raffaele. Participants must provide written informed consent and plan to deliver at San Raffaele Hospital.
The study is non-interventional and does not involve medicinal products, medical devices, diagnostic procedures, or therapeutic interventions outside routine clinical practice. The clinical consultation is conducted according to standard care, and participation in the study does not influence the healthcare professional's clinical decisions or the diagnostic or therapeutic pathway.
The study procedures include three main components. First, the participant attends the scheduled outpatient prenatal consultation with an OB-GYN or midwife experienced in VBAC. The consultation is audio-recorded to allow subsequent linguistic analysis. Second, following the consultation, the participant takes part in the SSI-CLAR semi-structured interview, lasting approximately 30 minutes, which assesses the participant's perceived clarity of communication, tone, accessibility of language, and subjective understanding of the information received. The interview is also audio-recorded and subsequently analysed using thematic analysis. Third, after delivery, information is collected concerning the method of delivery, specifically whether the participant underwent VBAC or caesarean section and, in the case of caesarean section, the clinical indication.
The primary objective is to evaluate the clarity and effectiveness of communication between healthcare professionals (OB-GYNs and midwives) and pregnant individuals during prenatal consultations concerning VBAC. The primary endpoint is the level of misunderstanding in clinician-patient conversations, measured through systematic analysis of consultation transcripts using the TouCAN Codebook. Coded misunderstandings will be quantified as counts and, where appropriate, as rates per consultation. Inter-rater reliability will also be assessed.
A secondary objective is to assess whether there is a match or mismatch between patterns of misunderstanding identified in clinical conversations and patients' own perceptions of communication as reported in the post-consultation interviews. The secondary endpoint is the degree of convergence or divergence between the level and types of misunderstandings identified through TouCAN Codebook coding and patients' perceived clarity and understanding as assessed through the semi-structured interviews.
The study will also explore the association between communication characteristics, perceived clarity, and the participant's subsequent decision regarding VBAC or a new caesarean section. Quantitative analyses will include descriptive statistics and exploratory Spearman correlations. A linear mixed-effects model will be used to explore the relationship between communication characteristics and perceived clarity, accounting for clustering at the clinician level. A logistic regression model will explore the association between communication characteristics and delivery outcomes. These quantitative analyses are exploratory and hypothesis-generating and are not intended to establish causal or predictive relationships.
The qualitative analysis of consultation transcripts will focus on identifying and characterising linguistic markers of misunderstanding using the TouCAN Codebook. Interview data will be analysed through thematic analysis, following a six-phase approach involving independent coding and collaborative synthesis. The combination of linguistic analysis and participants' subjective accounts is intended to capture both observable features of communication and patients' own perceptions of clarity, understanding, and communication quality.
All study data are collected in connection with the routine prenatal consultation and the subsequent assessment of communication and understanding. Participant involvement lasts approximately two hours. No additional clinical risk or therapeutic intervention is introduced by the study.
The study has a total duration of five years, with participant enrolment lasting two years. The study is sponsored by IRCCS Ospedale San Raffaele and co-sponsored by Università Vita-Salute San Raffaele. The Principal Investigator is Prof. Massimo Candiani.
- Keywords
- communication in perinatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant people considering VBAC | Pregnant individuals aged 18 to 44 years with a singleton pregnancy between 33 and 37 weeks of gestation, a history of caesarean section in a previous pregnancy, and a scheduled VBAC counselling consultation at IRCCS Ospedale San Raffaele. Participants must be Italian speakers, provide written informed consent, and plan to deliver at San Raffaele Hospital. The study is observational and involves no experimental intervention. Participants undergo their scheduled routine VBAC consultation, which is audio recorded for linguistic analysis, followed by a semi structured interview assessing their perceived understanding and clarity of the information received. Information on the subsequent mode of delivery is also collected after delivery. A total of 50 pregnant participants are planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of misunderstanding in clinician-patient conversations
he primary endpoint is the level of misunderstanding in clinician-patient conversations, measured through systematic analysis of consultation transcripts using the TouCAN Codebook.
Measured: During the prenatal consultation (Day 1)
Secondary outcomes (1)
Convergence or divergence between consultation based misunderstanding and patients' perceived communication
The degree of convergence or divergence between (a) the level and types of misunderstandings identified through TouCAN Codebook coding of consultations and (b) patients' perceived clarity and understanding as assessed via semi structured interviews.
Measured: On the day of the prenatal consultation (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start16 Sep 2026
- Primary completion16 Sep 2029 (estimated)
- Study completion16 Sep 2031 (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.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Responsible party
- Principal investigator, Candiani Massimo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919145
- Sponsor's protocol ID
- ComPARE - CET 209-2026
- Acronym
- ComPARE
- Status last verified
- Nov 2026
- First submitted
- 16 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ComPARE: Effective COMmunication in Perinatal cARE Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07919145
- Acronym / sponsor ID
- ComPARE / ComPARE - CET 209-2026
- Keywords
- communication in perinatal care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 16 Sep 2029 (estimated)
- Study completion
- 16 Sep 2031 (estimated)
- First posted
- 5 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.
ComPARE is a cross-sectional observational study investigating the effectiveness of communication during prenatal consultations concerning vaginal birth after caesarean (VBAC). It involves 50 pregnant people considering VBAC and 12 healthcare professionals from IRCCS Ospedale San Raffaele: 6 OB-GYNs and 6 midwives with expertise in VBAC. The main objective is to identify and analyse misunderstandings in doctor/midwife-patient communication, using the TouCAN Codebook, and to examine whether these misunderstandings are associated with patients' perceptions of communication quality. The study does not introduce any treatment or medical device: it analyses routine clinical consultations. The study period is 5 years, with 2 years of enrolment.
Detailed description
ComPARE (effective COMmunication in Perinatal cARE) is a cross-sectional observational study investigating the clarity, accessibility, and effectiveness of communication between healthcare professionals and pregnant individuals during prenatal consultations concerning vaginal birth after caesarean (VBAC).
Doctor-patient communication is an integral component of clinical care and is essential for establishing trust, supporting patient autonomy and shared decision-making, and promoting patient safety and quality of care. In clinical communication, misunderstandings may arise not only from the explicit content of what is said, but also from implicit assumptions, contextual cues, presuppositions, and non-literal meanings. The TouCAN Codebook (Textual misUnderstanding Codebook ANalysis) provides a structured linguistic framework for identifying markers of potentially problematic communication that may hinder mutual understanding. The present study applies this approach to perinatal care, with a specific focus on consultations concerning VBAC.
The study addresses the need for research specifically examining communication practices in VBAC counselling. These consultations involve the communication of complex and risk-sensitive information concerning pregnancy and birth and require information to be conveyed in a clear and accessible manner to support informed and autonomous decision-making.
The study population consists of 50 pregnant individuals considering VBAC and 12 healthcare professionals from IRCCS Ospedale San Raffaele, including 6 obstetricians and gynaecologists (OB-GYNs) and 6 midwives with expertise in VBAC. Eligible pregnant participants are Italian-speaking individuals aged 18-44 years with a singleton pregnancy between 33 and 37 weeks of gestation, a history of caesarean section in a previous pregnancy, and a scheduled VBAC counselling consultation at IRCCS Ospedale San Raffaele. Participants must provide written informed consent and plan to deliver at San Raffaele Hospital.
The study is non-interventional and does not involve medicinal products, medical devices, diagnostic procedures, or therapeutic interventions outside routine clinical practice. The clinical consultation is conducted according to standard care, and participation in the study does not influence the healthcare professional's clinical decisions or the diagnostic or therapeutic pathway.
The study procedures include three main components. First, the participant attends the scheduled outpatient prenatal consultation with an OB-GYN or midwife experienced in VBAC. The consultation is audio-recorded to allow subsequent linguistic analysis. Second, following the consultation, the participant takes part in the SSI-CLAR semi-structured interview, lasting approximately 30 minutes, which assesses the participant's perceived clarity of communication, tone, accessibility of language, and subjective understanding of the information received. The interview is also audio-recorded and subsequently analysed using thematic analysis. Third, after delivery, information is collected concerning the method of delivery, specifically whether the participant underwent VBAC or caesarean section and, in the case of caesarean section, the clinical indication.
The primary objective is to evaluate the clarity and effectiveness of communication between healthcare professionals (OB-GYNs and midwives) and pregnant individuals during prenatal consultations concerning VBAC. The primary endpoint is the level of misunderstanding in clinician-patient conversations, measured through systematic analysis of consultation transcripts using the TouCAN Codebook. Coded misunderstandings will be quantified as counts and, where appropriate, as rates per consultation. Inter-rater reliability will also be assessed.
A secondary objective is to assess whether there is a match or mismatch between patterns of misunderstanding identified in clinical conversations and patients' own perceptions of communication as reported in the post-consultation interviews. The secondary endpoint is the degree of convergence or divergence between the level and types of misunderstandings identified through TouCAN Codebook coding and patients' perceived clarity and understanding as assessed through the semi-structured interviews.
The study will also explore the association between communication characteristics, perceived clarity, and the participant's subsequent decision regarding VBAC or a new caesarean section. Quantitative analyses will include descriptive statistics and exploratory Spearman correlations. A linear mixed-effects model will be used to explore the relationship between communication characteristics and perceived clarity, accounting for clustering at the clinician level. A logistic regression model will explore the association between communication characteristics and delivery outcomes. These quantitative analyses are exploratory and hypothesis-generating and are not intended to establish causal or predictive relationships.
The qualitative analysis of consultation transcripts will focus on identifying and characterising linguistic markers of misunderstanding using the TouCAN Codebook. Interview data will be analysed through thematic analysis, following a six-phase approach involving independent coding and collaborative synthesis. The combination of linguistic analysis and participants' subjective accounts is intended to capture both observable features of communication and patients' own perceptions of clarity, understanding, and communication quality.
All study data are collected in connection with the routine prenatal consultation and the subsequent assessment of communication and understanding. Participant involvement lasts approximately two hours. No additional clinical risk or therapeutic intervention is introduced by the study.
The study has a total duration of five years, with participant enrolment lasting two years. The study is sponsored by IRCCS Ospedale San Raffaele and co-sponsored by Università Vita-Salute San Raffaele. The Principal Investigator is Prof. Massimo Candiani.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant people considering VBAC | – | –Pregnant individuals aged 18 to 44 years with a singleton pregnancy between 33 and 37 weeks of gestation, a history of caesarean section in a previous pregnancy, and a scheduled VBAC counselling consultation at IRCCS Ospedale San Raffaele. Participants must be Italian speakers, provide written informed consent, and plan to deliver at San Raffaele Hospital. The study is observational and involves no experimental intervention. Participants undergo their scheduled routine VBAC consultation, which is audio recorded for linguistic analysis, followed by a semi structured interview assessing their perceived understanding and clarity of the information received. Information on the subsequent mode of delivery is also collected after delivery. A total of 50 pregnant participants are planned. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of approximately 50 pregnant participants with a history of previous caesarean delivery who are considering vaginal birth after caesarean (VBAC). Participants will be recruited among patients attending prenatal counselling consultations at IRCCS Ospedale San Raffaele, Milan, Italy. Eligible participants will be between 18 and 44 years of age, have a singleton pregnancy between 33 and 37 weeks of gestation, and be planning delivery at the study hospital. The study will examine communicative misunderstandings during prenatal counselling and patients' perceptions of the information exchanged.
Key inclusion criteria (7 listed)
- Singleton pregnancy.
- Gestational age between 33 and 37 weeks at the time of the prenatal consultation.
- Maternal age between 18 and 44 years, inclusive.
- Ability to communicate in Italian and understand the study procedures.
- History of at least one previous caesarean delivery.
Key exclusion criteria (5 listed)
- Multiple pregnancy.
- Obstetric emergencies or urgent clinical conditions requiring immediate medical intervention that would prevent the planned prenatal counselling consultation.
- Inability to provide valid informed consent.
- Refusal of audio recording of the consultation.
- Clinical or logistical circumstances preventing participation in the interview following the consultation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of misunderstanding in clinician-patient conversations
Time frame: During the prenatal consultation (Day 1)
he primary endpoint is the level of misunderstanding in clinician-patient conversations, measured through systematic analysis of consultation transcripts using the TouCAN Codebook.
1 secondary outcome
Convergence or divergence between consultation based misunderstanding and patients' perceived communication
Time frame: On the day of the prenatal consultation (Day 1)
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 5 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?
An observational study of Pregnancy and Vbac, 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 7 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: looking for participants now, as of the sponsor's last update on 5 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 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?
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?
Level of misunderstanding in clinician-patient conversations (time frame: During the prenatal consultation (Day 1)). 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 5 Nov 2026.