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临床试验/NCT07124676
NCT07124676招募中不适用

Prospective Observational Study Comparing Two Classifications of Second-degree Perineal Tears in Spontaneous Vaginal Births, to Evaluate Their Correlation With Postpartum Clinical Outcomes.

University of Campania Luigi Vanvitelli2 个研究点 分布在 1 个国家目标入组 482 人开始时间: 2025年11月4日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
482
试验地点
2
主要终点
hemoglobin reduction

研究概览

简要总结

The goal of this observational study is to learn whether different classification systems for second-degree perineal tears can predict postpartum complications in women undergoing spontaneous vaginal childbirth. The main questions it aims to answer are:

Does the Scandinavian classification better predict postpartum complications such as hemoglobin drop, perineal pain, occult muscle injury, and sexual dysfunction? Does the De Simone classification better correlate with these same postpartum outcomes?

Researchers will compare the Scandinavian classification and the De Simone classification to see which system more accurately predicts clinically relevant postpartum complications.

Participants will:

Undergo standard clinical assessment after spontaneous vaginal delivery with a second-degree perineal tear Have their perineal tear classified using both the Scandinavian and De Simone systems Receive routine postpartum evaluation, including hemoglobin measurement, pain assessment (VAS), and perineal ultrasound Complete follow-up assessment of sexual function using the Female Sexual Function Index (FSFI)

详细描述

Second-degree perineal tears are heterogeneous injuries involving the perineal muscles without anal sphincter involvement, and their anatomical variability may influence postpartum outcomes. Current standard classifications do not provide detailed subclassification, limiting risk stratification.

This prospective, single-center observational study evaluates the prognostic performance of two detailed classification systems: the Scandinavian classification (based on the extent of the perineal body) and the De Simone classification (based on vaginal extension and muscle involvement).

Participants are consecutively enrolled following spontaneous vaginal delivery with second-degree tears. Classification is performed during routine postpartum examination by trained clinicians using both systems, with independent assessment to minimize misclassification.

Data are collected prospectively and managed in a secure electronic database with predefined validation and consistency checks. Source data verification is performed against clinical records, and variables are standardized through a predefined data dictionary.

The statistical approach includes multivariable modeling to assess the association between tear subtypes and clinical outcomes, adjusting for relevant confounders. Model performance will be evaluated using standard calibration and discrimination metrics, with predefined strategies for handling missing data.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female at birth
  • Age ≥ 18 years
  • Spontaneous vaginal delivery
  • Presence of a spontaneous second-degree perineal tear confirmed on -postpartum examination
  • Ability and willingness to provide informed consent

排除标准

  • Obstetric or medical conditions preventing spontaneous vaginal delivery
  • Inability to understand study procedures or complete follow-up assessments

研究组 & 干预措施

Women with spontaneous second-degree perineal tears

Participants are women who have a spontaneous vaginal birth and sustain a spontaneous second-degree perineal tear. Each tear is classified according to both the Scandinavian (Macedo et al., 2022) and De Simone systems during routine postpartum examination. No experimental intervention is performed; outcomes are collected through clinical records, postpartum examination, ultrasound, and validated questionnaires (FSFI).

结局指标

主要结局

hemoglobin reduction

时间窗: within 48 hours postpartum

significant hemoglobin reduction (\>2 g/dL from pre- to post-delivery)

moderate-to-severe perineal pain

时间窗: within 48 hours postpartum

Visual Analog Scale (VAS) ≥ 5; (VAS; range 0-10, where 0 = no pain and 10 = worst imaginable pain); moderate-to-severe pain defined as VAS ≥ 5

pathological Female Sexual Function Index (FSFI) total score

时间窗: within 48 hours after the delivery

FSFI total score modification after vaginal laceration Female Sexual Function Index (FSFI total score; range 2-36, where lower scores indicate worse sexual function and higher scores indicate better function), evaluated as change from baseline

次要结局

  • occult perineal or vaginal muscle lesions(within 7 days postpartum for ultrasound assessment; at 3 months postpartum for FSFI evaluation.)

研究者

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

Marco La Verde

Researcher

University of Campania Luigi Vanvitelli

研究点 (2)

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