NCT05678920

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

December 14, 2022

Last Update Submit

December 22, 2022

Conditions

Keywords

validationMEOWSchartTurkish

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Study Arms (1)

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

Other: patient-administered questionnaires

Interventions

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.

Pregnant and postpartum patients

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA study on obstetric patients hospitalized in obstetrics and gynecology clinics.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients whose pregnancy is older than 28 weeks and between 6 weeks postpartum

You may qualify if:

  • 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

You may not qualify if:

  • Patients who did not agree to participate in the study
  • Patients under the age of 18
  • Outpatients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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. eCollection 2019.

  • 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 Sep 29;20(1):568. doi: 10.1186/s12884-020-03187-1.

  • 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.2016.09.014. Epub 2016 Oct 8.

Study Officials

  • HALE KEFELI CELIK, MD

    Samsun Research and Education Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Principal Investigator

Study Record Dates

First Submitted

December 14, 2022

First Posted

January 10, 2023

Study Start

April 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

January 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study

Locations