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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05678920
Other study ID # MEOWS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date November 1, 2022

Study information

Verified date December 2022
Source Samsun Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date November 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients who did not agree to participate in the study - Patients under the age of 18 - Outpatients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
patient-administered questionnaires
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.

Locations

Country Name City State
Turkey Samsun Research and Education Hospital Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Moore 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. — View Citation

Singh 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. — View Citation

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. Erratum In: Anaesthesia. 20 — View Citation

Tuyishime 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 S — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Obstetric patients older than 28 weeks of gestation and between 6 weeks postpartum
Primary Modified Early Obstetric Warning System Chart Calculation of sensitivity, specificity, positive and negative predictive value of the chart At the end of the study, assessed up to 1 month.
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