Clinical Trials Directory

Trials / Completed

CompletedNCT07154862

Membrane Sweeping as an Induction Method and Maternal Experience: a Phenomenological Qualitative Study

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

Summary

This qualitative phenomenological study explores women's experiences with membrane sweeping, a common mechanical method of labor induction. Membrane sweeping is considered a low-cost and low-risk procedure recommended by several guidelines, including NICE, before proceeding to pharmacological or mechanical induction. Despite its widespread use, little evidence is available regarding how women perceive and experience this procedure. In this single-center, prospective observational study, women with low-risk singleton pregnancies between 40+0 and 41+2 weeks of gestation will be recruited at the "Oltretermine" outpatient clinic of Fondazione Policlinico Universitario Agostino Gemelli, Rome. After providing informed consent, participants who undergo membrane sweeping will be invited to take part in a semi-structured interview within 48-72 hours postpartum during hospital stay. The primary objective is to describe women's lived experiences of membrane sweeping at term. Secondary objectives include describing women's sociodemographic and obstetric characteristics and their overall birth experience. Data will be analyzed thematically to identify recurring concepts and themes. This study is independent, non-funded, and will enroll approximately 12-20 women, until data saturation is reached. All procedures comply with the Declaration of Helsinki, GDPR, and national privacy regulations.

Conditions

Timeline

Start date
2025-02-13
Primary completion
2025-05-14
Completion
2025-05-14
First posted
2025-09-04
Last updated
2025-09-10

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07154862. Inclusion in this directory is not an endorsement.