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Cesarean Section"PARENTS"NCT07152743

The Experience of Fathers and Mothers in Relation to the Presence of the Father at the Birth in the Case of a Planned Caesarean Section: a Qualitative Phenomenological Study

An observational study of Cesarean Section and Parturition, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Pregnancy and childbirth represent a crucial transition for couples, involving significant psychological and emotional adaptation. The World Health Organization recommends that all women have the possibility to be accompanied by a support person of their choice during labor and birth. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cesarean Section, Parturition
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2025to Feb 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Couples (mother and father) experiencing an elective cesarean section at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Mothers must be ≥37 weeks gestation and have provided written informed consent. Fathers and mothers must be ≥18 years old and able to understand Italian.

Who may be able to join

  • Women who have undergone an elective cesarean section
  • Women who have provided written informed consent
  • Women with gestational age > 37 weeks + 0 days

Who cannot join

  • Fathers or mothers under 18 years of age
  • Fathers or mothers unable to read and understand the Italian language

About this study

Official title: L'Esperienza Del Padre e Della Madre in Relazione Alla Presenza Del Padre All'Evento Parto in Caso di Taglio Cesareo Programmato: Uno Studio Qualitativo Fenomenologico

Pregnancy and childbirth represent a crucial transition for couples, involving significant psychological and emotional adaptation. The World Health Organization recommends that all women have the possibility to be accompanied by a support person of their choice during labor and birth. The presence of a trusted companion can provide emotional reassurance, improve communication with health professionals, and support non-pharmacological pain management, often reducing the need for medical interventions.

Fathers who attend childbirth frequently describe their participation as a meaningful and positive experience, strengthening their relationship with both the mother and the newborn. However, in the case of elective cesarean section, the father's presence in the operating room is not always allowed, especially when there is a high risk of complications (such as major hemorrhage). This variability may influence how mothers and fathers experience the birth.

Read more

This qualitative, single-center, non-funded study aims to explore and describe the lived experiences of mothers and fathers regarding the presence or absence of the father during an elective cesarean section.

After informed consent, couples will be invited to participate in a semi-structured interview conducted 48-72 hours after birth, during postpartum hospitalization at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. The interview, lasting approximately 20-30 minutes, will be audio-recorded and anonymized. Participants may withdraw at any time without consequences for their care.

The primary objective is to describe the experience of both mothers and fathers in relation to whether the father was present or absent at the birth. Secondary objectives include:

describing demographic and obstetric characteristics of participating women,

exploring expectations and emotions of fathers who attended the cesarean birth and of their partners,

exploring the experiences of fathers who could not be present, and of their partners,

evaluating the perceived support provided by healthcare staff,

identifying unexpected needs or desires expressed by participants.

A purposive sample of approximately 30 couples will be recruited (15 where the father is present and 15 where he is absent). Recruitment will continue until data saturation is reached. Data will be analyzed using thematic analysis, following established qualitative research methods.

This study will provide new insights into how the presence or absence of the father during elective cesarean section shapes the birth experience for both parents. The results may support policies and practices aimed at improving emotional well-being, strengthening family bonds, and enhancing the quality of maternity care.

Keywords
Parent, Father, Cesarean Section

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To describe the lived experience of mothers and fathers in relation to the father's presence or absence during elective cesarean birth.

    Semi-structured interview conducted with mothers and fathers after childbirth

    Measured: 48-72 hours postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07152743
Sponsor's protocol ID
7528
Acronym
"PARENTS"
Status last verified
Apr 2025
First submitted
26 Aug 2025
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Section and Parturition, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe the lived experience of mothers and fathers in relation to the father's presence or absence during elective cesarean birth. (time frame: 48-72 hours postpartum). 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 10 Sep 2025.

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