Pregnancy ComplicationsNCT06488690
Early Warning Scores in Pregnant Woman
A study testing All patients who were pregnant and underwent cesarean section in people with Pregnancy Complications, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- All patients who were pregnant and underwent cesarean section
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Feb 2024
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who are pregnant and undergo cesarean section
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, Merkez, 32200
About this study
Official title: 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.
Read the 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).
- Conditions
- Pregnancy Complications
- Being tested
- All patients who were pregnant and underwent cesarean section
- Keywords
- Early Warning Scores, MEOWS, MEWC, MEWT, Pregnant Women, Maternal Morbidity
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients who were pregnant and underwent cesarean sectionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: All patients who were pregnant and underwent cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One year
Secondary outcomes (3)
APGAR score
APGAR scores at 1st and 5th minutes were calculated for postnatal babies.
Measured: One year
Aldrete score
The Modified Aldrete Recovery Score System was computed for mothers to assess postoperative recovery.
Measured: One year
Glasgow Coma Scale
The Glasgow Coma Scale (GCS) was used to evaluate the consciousness of pregnant women.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Pregnant woman
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onurcan BALIK, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488690
- Sponsor's protocol ID
- SuleymanDU-MD-OB-01
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Warning Scores: Preoperative Period in Pregnant Women
- ClinicalTrials.gov ID
- NCT06488690
- Acronym / sponsor ID
- SuleymanDU-MD-OB-01
- Conditions
- Pregnancy Complications
- Keywords
- Early Warning Scores, MEOWS, MEWC, MEWT, Pregnant Women, Maternal Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 5 Jul 2024 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnant woman
| Arm | Type | Receives |
|---|---|---|
| All patients who are pregnant and undergo cesarean section | Other | Other: All patients who were pregnant and underwent cesarean sectionWe included all patients who were pregnant and underwent cesarean section and calculated maternal early warning scores. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are pregnant and undergo cesarean section
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| All patients who were pregnant and underwent cesarean sectionOur 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. | Other | All patients who are pregnant and undergo cesarean section |
Primary outcome
MEOWS, MEWC and MEWT scores
Time frame: One year
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.
MEWC score
Time frame: One year
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.
MEWT score
Time frame: One year
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.
3 secondary outcomes
APGAR score
Time frame: One year
Aldrete score
Time frame: One year
Glasgow Coma Scale
Time frame: One year
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 5 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All patients who were pregnant and underwent cesarean section in people with Pregnancy Complications, run by Suleyman Demirel University 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 1 inclusion and 1 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 5 Jul 2024. 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?
MEOWS, MEWC and MEWT scores (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024.