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

NCT07154862 | Completed

• 1 other identifier: 7350
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Membrane Stripping; Patient Experience; Labour, Induced; Phenomenology

Outcome Measures

Primary Outcomes (1)

• Lived experience of membrane sweeping

  Qualitative description of women's perceptions, feelings, and overall experience related to membrane sweeping at term. Data will be collected through semi-structured interviews and analyzed thematically.

  Within 48-72 hours after childbirth

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Nulliparous and multiparous women aged 18-40 years, with singleton cephalic pregnancies at 40+0 to 41+2 weeks of gestation, receiving care at the "Oltretermine" outpatient clinic of Fondazione Policlinico Universitario Agostino Gemelli, Rome. Participants must be able to read and understand Italian and provide written informed consent.

You may qualify if:

• Women aged \>18 and ≤40 years
• Women with singleton pregnancy
• Women with cephalic presentation
• Women able to read and understand the Italian language
• Women with gestational age between 40+0 and 41+2 weeks
• Signed informed consent provided by the participant

You may not qualify if:

• Women younger than 18 years or older than 40 years
• Women unable to read and understand the Italian language

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Scientific Direction

Roma, Italy

Location

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 27, 2025
• First Posted: September 4, 2025
• Study Start: February 13, 2025
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-02

Locations

IT (1)