ValidationNCT05678920
Validation of the Turkish Version of the Modified Early Obstetric Warning Systems (MEOWS) Charts
An observational study of Validation, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to study MEOWS on patients in the obstetrics clinic and to evaluate the performance of this scale as a screening tool and to contribute to its usability in Turkey by translating MEOWS into Turkish. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Validation
- What is being tested?
- patient-administered questionnaires
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Nov 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients whose pregnancy is older than 28 weeks and between 6 weeks postpartum
Who may be able to join
- Obstetric patients receiving inpatient treatment in obstetrics and gynecology clinics
- Patients whose pregnancy is older than 28 weeks and between 6 weeks postpartum
- Patients who agreed to participate in the study
Who cannot join
- Patients who did not agree to participate in the study
- Patients under the age of 18
- Outpatients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Research and Education Hospital
Samsun, 55090
About this study
It was aimed to study MEOWS on patients in the obstetrics clinic and to evaluate the performance of this scale as a screening tool and to contribute to its usability in Turkey by translating MEOWS into Turkish.
Read the detailed description
The Modified Early Obstetric Warning System (MEOWS) is a score-based or color-coded system used to detect changes in physiological parameters and enable earlier recognition and management of deteriorating patients.It was first validated by Sigh et al., then its validity and reliability were demonstrated in many countries, especially in countries with low socio-economic status.Early warning systems are not routinely used in obstetrics clinics in Turkey, and there is no Turkish version of MEOWS in the literature. In this study, it was aimed to study MEOWS on patients in obstetrics clinics and to evaluate the performance of this scale as a screening tool and to validate MEOWS by translating it into Turkish.
The study was carried out in 3 stages. The first stage is the translation of MEOWS into Turkish and its cultural adaptation, the second stage is the use of the study scale and the elimination of deficiencies by conducting a pilot study on 30 patients, and the third stage is the collection and evaluation of patient data until the specified sample size is reached.
- Conditions
- Validation
- Being tested
- patient-administered questionnaires
- Keywords
- validation, MEOWS, chart, Turkish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-administered questionnairesOther
patient-administered questionnaires (MEOWS): Obstetric early warning systems are recommended to provide timely recognition, treatment and early referral of critically ill or developing patients. The development of early warning systems from simple bedside observation charts arose from the knowledge that physiological disturbances precede critical illness. Thanks to these charts, the fact that the patient's findings are in the risky value ranges allows the clinician to evaluate the patient earlier and in detail. MEOWS is a simple screening tool for maternal morbidity.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant and postpartum patients | Pregnant patients older than 28th gestational week and patients up to postpartum 6th week who were hospitalized in the obstetrics department Receives: Other: patient-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Modified Early Obstetric Warning System
Demonstrating the reliability and validity of the Modified Early Obstetric Warning System chart in Turkish. MEOWS chart is contained within a booklet and is commenced on admission to hospital. The same booklet is used during subsequent admissions to hospital during the relevant pregnant and postnatal period. Specific maternal observations that are recorded on the MEOWS chart are diastolic blood pressure, severity of pain, antenatal discharge and/or postnatal lochia and proteinurea. Physiological parameters which deviate from the norm are allocated a score. The score increases as deviation from the norm escalates. The final score then falls into one of three categories: a low, medium, or high score. A low score is 1-4, a medium score is 5-6 and a high score is 7 or more. Any single score of 3 indicates an extreme variation from the normal, which is considered at least a medium score. The colour prompts are green for a low score, amber for medium and red for high scores.
Measured: Obstetric patients older than 28 weeks of gestation and between 6 weeks postpartum
Modified Early Obstetric Warning System Chart
Calculation of sensitivity, specificity, positive and negative predictive value of the chart
Measured: At the end of the study, assessed up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ValidationStudies 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Kefeli Celik, Samsun Education and Research Hospital
- Investigators
- HALE KEFELI CELIK, MD, Study director, Samsun Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678920
- Sponsor's protocol ID
- MEOWS
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study
Publications
Singh S, McGlennan A, England A, Simons R. A validation study of the CEMACH recommended modified early obstetric warning system (MEOWS). Anaesthesia. 2012 Jan;67(1):12-18. doi: 10.1111/j.1365-2044.2011.06896.x. Epub 2011 Nov 9.
PubMed 22066604Moore J, Thomson D, Pimentil I, Fekad B, Graham W. Introduction of a modified obstetric early warning system -(-MOEWS-)- at an Ethiopian referral hospital: a feasibility assessment. BMJ Open Qual. 2019 Mar 30;8(1):e000503. doi: 10.1136/bmjoq-2018-000503. eCollection 2019.
PubMed 31206042Tuyishime E, Ingabire H, Mvukiyehe JP, Durieux M, Twagirumugabe T. Implementing the Risk Identification (RI) and Modified Early Obstetric Warning Signs (MEOWS) tool in district hospitals in Rwanda: a cross-sectional study. BMC Pregnancy Childbirth. 2020 Sep 29;20(1):568. doi: 10.1186/s12884-020-03187-1.
PubMed 32993541Singh A, Guleria K, Vaid NB, Jain S. Evaluation of maternal early obstetric warning system (MEOWS chart) as a predictor of obstetric morbidity: a prospective observational study. Eur J Obstet Gynecol Reprod Biol. 2016 Dec;207:11-17. doi: 10.1016/j.ejogrb.2016.09.014. Epub 2016 Oct 8.
PubMed 27792988
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Turkish Version of the Modified Early Obstetric Warning Systems (MEOWS) Charts
- ClinicalTrials.gov ID
- NCT05678920
- Acronym / sponsor ID
- MEOWS
- Conditions
- Validation
- Keywords
- validation, MEOWS, chart, Turkish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 10 Jan 2023 (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.
It was aimed to study MEOWS on patients in the obstetrics clinic and to evaluate the performance of this scale as a screening tool and to contribute to its usability in Turkey by translating MEOWS into Turkish.
Detailed description
The Modified Early Obstetric Warning System (MEOWS) is a score-based or color-coded system used to detect changes in physiological parameters and enable earlier recognition and management of deteriorating patients.It was first validated by Sigh et al., then its validity and reliability were demonstrated in many countries, especially in countries with low socio-economic status.Early warning systems are not routinely used in obstetrics clinics in Turkey, and there is no Turkish version of MEOWS in the literature. In this study, it was aimed to study MEOWS on patients in obstetrics clinics and to evaluate the performance of this scale as a screening tool and to validate MEOWS by translating it into Turkish.
The study was carried out in 3 stages. The first stage is the translation of MEOWS into Turkish and its cultural adaptation, the second stage is the use of the study scale and the elimination of deficiencies by conducting a pilot study on 30 patients, and the third stage is the collection and evaluation of patient data until the specified sample size is reached.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant and postpartum patients | – | Other: patient-administered questionnairesPregnant patients older than 28th gestational week and patients up to postpartum 6th week who were hospitalized in the obstetrics department |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients whose pregnancy is older than 28 weeks and between 6 weeks postpartum
Key inclusion criteria (3 listed)
- Obstetric patients receiving inpatient treatment in obstetrics and gynecology clinics
- Patients whose pregnancy is older than 28 weeks and between 6 weeks postpartum
- Patients who agreed to participate in the study
Key exclusion criteria (3 listed)
- Patients who did not agree to participate in the study
- Patients under the age of 18
- Outpatients
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 |
|---|---|---|
| patient-administered questionnairespatient-administered questionnaires (MEOWS): Obstetric early warning systems are recommended to provide timely recognition, treatment and early referral of critically ill or developing patients. The development of early warning systems from simple bedside observation charts arose from the knowledge that physiological disturbances precede critical illness. Thanks to these charts, the fact that the patient's findings are in the risky value ranges allows the clinician to evaluate the patient earlier and in detail. MEOWS is a simple screening tool for maternal morbidity. | Other | Pregnant and postpartum patients |
Primary outcome
Validation of the Modified Early Obstetric Warning System
Time frame: Obstetric patients older than 28 weeks of gestation and between 6 weeks postpartum
Demonstrating the reliability and validity of the Modified Early Obstetric Warning System chart in Turkish. MEOWS chart is contained within a booklet and is commenced on admission to hospital. The same booklet is used during subsequent admissions to hospital during the relevant pregnant and postnatal period. Specific maternal observations that are recorded on the MEOWS chart are diastolic blood pressure, severity of pain, antenatal discharge and/or postnatal lochia and proteinurea. Physiological parameters which deviate from the norm are allocated a score. The score increases as deviation from the norm escalates. The final score then falls into one of three categories: a low, medium, or high score. A low score is 1-4, a medium score is 5-6 and a high score is 7 or more. Any single score of 3 indicates an extreme variation from the normal, which is considered at least a medium score. The colour prompts are green for a low score, amber for medium and red for high scores.
Modified Early Obstetric Warning System Chart
Time frame: At the end of the study, assessed up to 1 month.
Calculation of sensitivity, specificity, positive and negative predictive value of the chart
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 10 Jan 2023.
- Results publication: PubMed 22066604Singh S, McGlennan A, England A, Simons R. A validation study of the CEMACH recommended modified early obstetric warning system (MEOWS). Anaesthesia. 2012 Jan;67(1):12-18. doi: 10.1111/j.1365-2044.2011.06896.x. Epub 2011 Nov 9.
- Results publication: PubMed 31206042Moore J, Thomson D, Pimentil I, Fekad B, Graham W. Introduction of a modified obstetric early warning system -(-MOEWS-)- at an Ethiopian referral hospital: a feasibility assessment. BMJ Open Qual. 2019 Mar 30;8(1):e000503. doi: 10.1136/bmjoq-2018-000503. eCollection 2019.
- Results publication: PubMed 32993541Tuyishime E, Ingabire H, Mvukiyehe JP, Durieux M, Twagirumugabe T. Implementing the Risk Identification (RI) and Modified Early Obstetric Warning Signs (MEOWS) tool in district hospitals in Rwanda: a cross-sectional study. BMC Pregnancy Childbirth. 2020 Sep 29;20(1):568. doi: 10.1186/s12884-020-03187-1.
- Results publication: PubMed 27792988Singh A, Guleria K, Vaid NB, Jain S. Evaluation of maternal early obstetric warning system (MEOWS chart) as a predictor of obstetric morbidity: a prospective observational study. Eur J Obstet Gynecol Reprod Biol. 2016 Dec;207:11-17. doi: 10.1016/j.ejogrb.2016.09.014. Epub 2016 Oct 8.
- Individual participant dataSharing planned: No. Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study
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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.
HALE KEFELI CELIK, MD study director
Samsun Research and Education Hospital
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 Validation, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 10 Jan 2023. 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 Turkey (Türkiye). 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?
Validation of the Modified Early Obstetric Warning System (time frame: Obstetric patients older than 28 weeks of gestation and between 6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678920, which also lists 4 linked publications.
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 10 Jan 2023.