Pain, LaborNCT05226208
Labour Pain is a Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on Indirect Factors
An observational study of Pain, Labor, run by Bogomolets National Medical University at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Labor
- What is being tested?
- Visual analogue scale (VAS) and General anxiety scale (GAD-2) and survey
- How many people
- 366 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Dec 2020to 28 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus
Who may be able to join
- mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus.
Who cannot join
- mothers over 45 years of age, inability to obtain the informed consent of the patient or his legal representative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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).
- Conditions
- Pain, Labor
- Being tested
- Visual analogue scale (VAS), General anxiety scale (GAD-2) and survey
- Keywords
- labor pain, antenatal education, support by doula
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 surveyDiagnostic test
In the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Women with not severe labour pain | Group 1 included 282 patients (pain level ≥7 mm according to the VAS). Receives: Diagnostic Test: Visual analogue scale (VAS); Diagnostic Test: General anxiety scale (GAD-2) and survey | |
| Women with severe labour pain | Group 2 included 84 patients (pain level ≤ 6 mm using the VAS). Receives: Diagnostic Test: Visual analogue scale (VAS); Diagnostic Test: General anxiety scale (GAD-2) and survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Dec 2020
- Primary completion1 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasiia Romanenko, MD, Bogomolets National Medical University
- Investigators
- Iurii Kuchyn, PhD, Study director, Bogomolets National Medical UniversityDmytro Govsieiev, PhD, Study director, Bogomolets National Medical UniversityKateryna Bielka, PhD, Study chair, Bogomolets National Medical UniversityAnastasiia Romanenko, MD, Principal investigator, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226208
- Sponsor's protocol ID
- 0002-9033-149X
- Status last verified
- Feb 2022
- First submitted
- 20 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Severe Labor Pain: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05226208
- Acronym / sponsor ID
- 0002-9033-149X
- Conditions
- Pain, Labor
- Keywords
- labor pain, antenatal education, support by doula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with not severe labour pain | – | Diagnostic Test: Visual analogue scale (VAS), Diagnostic Test: General anxiety scale (GAD-2) and surveyGroup 1 included 282 patients (pain level ≥7 mm according to the VAS). |
| Women with severe labour pain | – | Diagnostic Test: Visual analogue scale (VAS), Diagnostic Test: General anxiety scale (GAD-2) and surveyGroup 2 included 84 patients (pain level ≤ 6 mm using the VAS). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus
Key inclusion criteria (1 listed)
- mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus.
Key exclusion criteria (1 listed)
- mothers over 45 years of age, inability to obtain the informed consent of the patient or his legal representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Women with not severe labour pain, Women with severe labour pain |
| General anxiety scale (GAD-2) and surveyIn the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery. | Diagnostic test | Women with not severe labour pain, Women with severe labour pain |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- World Health Organization (WHO). Intrapartum care for a positive childbirth experience: a practical guide. Accessed 7 February 2018.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iurii Kuchyn, PhD study director
Bogomolets National Medical University
Dmytro Govsieiev, PhD study director
Bogomolets National Medical University
Kateryna Bielka, PhD study chair
Bogomolets National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Labor, run by Bogomolets National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal anxiety level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.