Effective Communication in Perinatal Care (ComPARE)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Vbac

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • IRCCS Ospedale San Raffaele
      • Contact: Massimo Candiani, Professor; Phone Number: +39 02 2643 2653; Email: candiani.massimo@hsr.it
      • Contact: Mara Floris, PhD; Email: floris.mara@unisr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria

1. Singleton pregnancy.
2. Gestational age between 33 and 37 weeks at the time of the prenatal consultation.
3. Maternal age between 18 and 44 years, inclusive.
4. Ability to communicate in Italian and understand the study procedures.
5. History of at least one previous caesarean delivery.
6. Planned delivery at IRCCS Ospedale San Raffaele.
7. Provision of written informed consent for study participation and audio recording of the consultation.

Exclusion Criteria

1. Multiple pregnancy.
2. Obstetric emergencies or urgent clinical conditions requiring immediate medical intervention that would prevent the planned prenatal counselling consultation.
3. Inability to provide valid informed consent.
4. Refusal of audio recording of the consultation.
5. Clinical or logistical circumstances preventing participation in the interview following the consultation.

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: CROSS_SECTIONAL

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the prenatal consultation (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	On the day of the prenatal consultation (Day 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive mapping of the types of communicative misunderstandings observed across consultations	Descriptive mapping of the types of communicative misunderstandings observed across consultations.	During the prenatal consultation (Day 1)
Convergence or divergence between misunderstandings, perceived clarity and delivery decision	The degree of convergence or divergence between (a) the level and types of misunderstandings identified through TouCAN Codebook coding of consultations, (b) patients' perceived clarity and understanding as assessed via semi structured interviews and (c) the decision of the pregnant person to undergo a VBAC or a CS.	During the prenatal consultation (Day 1)

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Università Vita-Salute San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2026
• Primary Completion (Estimated): September 16, 2029
• Study Completion (Estimated): September 16, 2031

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: communication in perinatal care
• Other Study ID Numbers: ComPARE - CET 209-2026

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