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

February 23, 2022 updated by: Anastasiia Romanenko, MD, Bogomolets National Medical University

Predictors of Severe Labor Pain: Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

366

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kiev, Ukraine
        • Bogomolets National Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with not severe labour pain
Group 1 included 282 patients (pain level ≥7 mm according to the VAS).
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.
Diagnostic test: 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.
Women with severe labour pain
Group 2 included 84 patients (pain level ≤ 6 mm using the VAS).
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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bogomolets National Medical University

Investigators

  • Study Director: Dmytro Govsieiev, PhD, Bogomolets National Medical University
  • Study Chair: Kateryna Bielka, PhD, Bogomolets National Medical University
  • Principal Investigator: Anastasiia Romanenko, MD, Bogomolets National Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 28, 2021

Study Registration Dates

First Submitted

November 20, 2021

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002-9033-149X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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