Early Warning Scores in Pregnant Woman

Effectiveness of Early Warning Scores: Preoperative Period in Pregnant Women

Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications
• Intervention / Treatment: Other: All patients who were pregnant and underwent cesarean section

Detailed Description

Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

This prospective study included 304 patients undergoing cesarean section at Suleyman Demirel University between April 2022 and April 2023. Physiological parameters were assessed in all 304 pregnant women before the operation. Maternal early warning scores, including modified early obstetric warning score (MEOWS), maternal early warning score (MEWC), and maternal early warning triggers (MEWT), were calculated for each patient. Patients triggering the system were classified as Group 1 (risky patients), while those not triggering the system were classified as Group 2 (risk-free patients).

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Isparta, Merkez, Turkey, 32200
      • Suleyman Demirel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients who are pregnant and undergo cesarean section

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All patients who are pregnant and undergo cesarean section; We included all patients who were pregnant and underwent cesarean section and calculated maternal early warning scores.	Other: All patients who were pregnant and underwent cesarean section; Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEOWS, MEWC and MEWT scores	The presence of a "trigger" for MEOWS in all systems, defined as either a single severely abnormal parameter (falling in the "red" zone) or two slightly abnormal parameters (falling in the "yellow" zone), was categorized as the risky group. Absence or mildness of the trigger was considered as the risk-free group.	One year
MEWC score	In the case of MEWC, the presence of only one abnormal parameter designated the risk group, while the absence of a trigger indicated the risk-free group.	One year
MEWT score	For MEWT, the presence of a "trigger" defined as either a single severely abnormal parameter (falling in the "red" zone) or two mildly abnormal parameters (falling in the "yellow" zone) was categorized as the risky group, with the absence or mildness of the trigger considered as the risk-free group.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR score	APGAR scores at 1st and 5th minutes were calculated for postnatal babies.	One year
Aldrete score	The Modified Aldrete Recovery Score System was computed for mothers to assess postoperative recovery.	One year
Glasgow Coma Scale	The Glasgow Coma Scale (GCS) was used to evaluate the consciousness of pregnant women.	One year

Collaborators and Investigators

• Sponsor: Suleyman Demirel University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pregnant Women; Maternal Morbidity; Early Warning Scores; MEOWS; MEWC; MEWT
• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications
• Other Study ID Numbers: SuleymanDU-MD-OB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No