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Completed

NCT Number: NCT05226208

Labour Pain is a Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on Indirect Factors

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bogomolets National Medical University

Kiev, Ukraine

About this study

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:

  • Demographic indicators (age, level of working capacity 2 months before childbirth, attendance of maternity school).
  • General level of health (woman's level of health before childbirth, daily physical activity before childbirth, bad habits - smoking during pregnancy).
  • 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).
  • 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.
  • Presence of chronic intestinal diseases (irritable bowel syndrome).
  • The level of assistance during childbirth (constant support of the doula during childbirth, the woman's ability to control pain in childbirth).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Visual Analogue Scale (VAS)

Diagnostic Test

In the postpartum period all patients filled VAS and underwent interviews from the 1st to the 3rd day after delivery.

General anxiety scale (GAD-2) and survey

Diagnostic Test

In the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery.

Primary outcomes

  1. Prenatal anxiety level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Registry information

Official study title

Predictors of Severe Labor Pain: Prospective Observational Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2022
Registry last updated
Mar 2, 2022

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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