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

Pain, Labor Clinical Trial

Official title:

Predictors of Severe Labor Pain: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226208
• Other study ID #: 0002-9033-149X
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: February 2022
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: May 28, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain
• Pain, Labor

Intervention

Diagnostic Test:
• Visual analogue scale (VAS)
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
In the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery.

Locations

Country	Name	City	State
Ukraine	Bogomolets National Medical University	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prenatal anxiety level	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.	6 months

External Links

•   World Health Organization (WHO). Intrapartum care for a positive childbirth experience: a practical guide. Accessed 7 February 2018.