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临床试验/NCT05226208
NCT05226208已完成不适用

Predictors of Severe Labor Pain: Prospective Observational Study

Bogomolets National Medical University1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2020年12月1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
366
试验地点
1
主要终点
Prenatal anxiety level

研究概览

简要总结

Pain During Childbirth is a Complex and Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on the Intensity of Labour Pain and Many Indirect Factors. Complex Interrelated Effects on Labour Pain Are Limited by the Little Number of Studies Available. That is Why it is Necessary to Determine the Probable Factors That May Affect the Intensity of Pain.

详细描述

A prospective observational study was conducted in the period from December 2020 to May 2021 at the Kyiv City Maternity Hospital №5 (Kyiv, Ukraine). The study protocol was approved by the Bogomolets National Medical University Ethics Committee. The examined predictors were derived from mothers' self-report of overall childbirth. 366 women took part in research, 282 of participants rated their pain by ≤ 60 mm visual analog scale (VAS), while 84 patients reported their pain by ≥70 mm VAS. The aim of study was to investigate predictors of severe labour pain. In the postpartum period all patients filled questionnaires and underwent interviews from the 1st to the 3rd day after delivery. The following groups of risk factors were studied:

  1. Demographic indicators (age, level of working capacity 2 months before childbirth, attendance of maternity school).
  2. General level of health (woman's level of health before childbirth, daily physical activity before childbirth, bad habits - smoking during pregnancy).
  3. Presence of mental disorders before childbirth (level of anxiety 2 weeks before childbirth, widespread muscle pain with fatigue or problems with memory, sleep, and mood).
  4. The presence of chronic pain, chronic headache or chronic back pain, the presence of rheumatoid arthritis during pregnancy, the presence of increased intracranial pressure during pregnancy.
  5. Presence of chronic intestinal diseases (irritable bowel syndrome).
  6. The level of assistance during childbirth (constant support of the doula during childbirth, the woman's ability to control pain in childbirth).

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus.

排除标准

  • mothers over 45 years of age, inability to obtain the informed consent of the patient or his legal representative.

结局指标

主要结局

Prenatal anxiety level

时间窗: 6 months

Generalized Anxiety Disorder-2 scale is a tool, which confirms the diagnosis of generalized anxiety disorder. A positive Generalized Anxiety Disorder-2 scale result is a score of at least 3 points. It is considered to be negative outcome.

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

Anastasiia Romanenko, MD

Principal Investigator

Bogomolets National Medical University

研究点 (1)

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