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

NCT ID: NCT07154862

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-13

Study Completion Date

2025-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Membrane Stripping Patient Experience Labour, Induced Phenomenology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Women younger than 18 years or older than 40 years
* Women unable to read and understand the Italian language
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Preziosi Jessica

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Scientific Direction

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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7350

Identifier Type: -

Identifier Source: org_study_id

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