Clinical trial NCT05226208: Labour Pain is a Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on Indirect Factors
Official title: Predictors of Severe Labor Pain: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Labor
Keywords: labor pain
antenatal education
support by doula
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 366
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Prenatal anxiety level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: Bogomolets National Medical University
Study officials:
affiliation: Bogomolets National Medical University
name: Iurii Kuchyn, PhD
role: STUDY_DIRECTOR
affiliation: Bogomolets National Medical University
name: Dmytro Govsieiev, PhD
role: STUDY_DIRECTOR
affiliation: Bogomolets National Medical University
name: Kateryna Bielka, PhD
role: STUDY_CHAIR
affiliation: Bogomolets National Medical University
name: Anastasiia Romanenko, MD
role: PRINCIPAL_INVESTIGATOR
References: