NCT06488690

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

June 27, 2024

Last Update Submit

July 3, 2024

Conditions

Keywords

Early Warning ScoresMEOWSMEWCMEWTPregnant WomenMaternal Morbidity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • APGAR score

    One year

  • Aldrete score

    One year

  • Glasgow Coma Scale

    One year

Study Arms (1)

All patients who are pregnant and undergo cesarean section

OTHER

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

Interventions

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.

All patients who are pregnant and undergo cesarean section

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Woman
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who are pregnant and undergo cesarean section

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, Merkez, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Pregnant woman
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

February 1, 2024

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations