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OpenTrials
Completed

NCT Number: NCT07154862

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Scientific Direction

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lived experience of membrane sweeping

    Time frame: Within 48-72 hours after childbirth

    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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: Sweep

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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