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临床试验/NCT07154862
NCT07154862已完成不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Lived experience of membrane sweeping

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

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

结局指标

主要结局

Lived experience of membrane sweeping

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Preziosi Jessica

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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