NCT07152743

Brief 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. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 10, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

August 26, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

ParentFatherCesarean Section

Outcome Measures

Primary Outcomes (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

    48-72 hours postpartum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

September 10, 2025

Record last verified: 2025-04