High Risk Pregnancy and Maternal Near Miss CasesNCT06262568
Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases
An observational study of High Risk Pregnancy and Maternal Near Miss Cases, run by Sohag University at 1 site in Egypt.
Trial summary
The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- High Risk Pregnancy and Maternal Near Miss Cases
- What is being tested?
- assess the nurse knowledge and practices.
- How many people
- 71 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Jun 2024
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Adult
Study population: all nurses
Who may be able to join
- all nurses staff
Who cannot join
- nurses who refuse participation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
ghona Abd EL-Nasser, Professor, 01123067894, mahmoud.hazem@nursing.sohag.edu.eg
About this study
Official title: Effect of Instructional Guidelines on Maternity Nurses' Awareness Toward High Risk Pregnancy and Maternal Near Miss Cases
The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education.
Read the detailed description
Maternal morbidity is defined as ill-health in a woman during pregnancy, irrespective of pregnancy site or duration, which is caused or aggravated by the pregnancy or its management, but which is not caused by accident or incident. This concept ranges from mild to severe maternal morbidity (SMM). Maternal near-miss (MNM) and potentially life-threatening conditions (PLTCs) are included as SMM.(Mekonnen et al., 2021) . Maternal mortality is an indicator of many parameters of maternal health, such as women's status, access to care and quality of care in low resource settings.(Mohammed et al., 2020) Maternal near-miss precedes maternal mortality, and women are still alive indicating that the numbers of near-misses occur more often than maternal mortality.(Mekonnen et al., 2021) Maternal near miss case is defined as "a woman who nearly died but survived a complication that occurred during pregnancy, childbirth, or within 42 days of termination of pregnancy"(Ninama et al., 2022) High risk pregnancy is defined as one where pregnancy is complicated by factor or factors that adversely affects the outcome- maternal or perinatal or both. Women with high-risk pregnancies should receive care from a special team of health care providers to ensure the best possible outcomes. (Arjariya \& Tiwari, .2021) .High-risk pregnancy was classified based on the guidelines provided by Pradhan Mantri Surakshit Matritva Abhiyan (PMSMA) for identification of high-risk pregnancy by health-care workers. The parameters considered for diagnosis of high- risk pregnancy were also defined as per the guidelines provided by PMSMA. Antenatal women with the following conditions were categorized under high-risk pregnancy: a. Severe anemia with hemoglobin level 140/90 mmHg) b. Hypertensive disorder in pregnancy (blood pressure >140/90 mmHg) c. Previous history of lower segment cesarean section d. Bad obstetric history (history of obstructed labor) e. Low-lying placenta or placenta previa. .(Arjariya \& Tiwari.,2021)
- Being tested
- assess the nurse knowledge and practices.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assess the nurse knowledge and practices.Other
assess the nurse knowledge and practices.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training
Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Apr 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Pregnancy and Maternal Near Miss CasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hazem Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262568
- Sponsor's protocol ID
- Soh-Med-23-03-18MS
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instructional Guidelines on Maternity Nurses' Awareness Toward High Risk Pregnancy and Maternal Near Miss Cases
- ClinicalTrials.gov ID
- NCT06262568
- Acronym / sponsor ID
- Soh-Med-23-03-18MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Feb 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.
The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education.
Detailed description
Maternal morbidity is defined as ill-health in a woman during pregnancy, irrespective of pregnancy site or duration, which is caused or aggravated by the pregnancy or its management, but which is not caused by accident or incident. This concept ranges from mild to severe maternal morbidity (SMM). Maternal near-miss (MNM) and potentially life-threatening conditions (PLTCs) are included as SMM.(Mekonnen et al., 2021) . Maternal mortality is an indicator of many parameters of maternal health, such as women's status, access to care and quality of care in low resource settings.(Mohammed et al., 2020) Maternal near-miss precedes maternal mortality, and women are still alive indicating that the numbers of near-misses occur more often than maternal mortality.(Mekonnen et al., 2021) Maternal near miss case is defined as "a woman who nearly died but survived a complication that occurred during pregnancy, childbirth, or within 42 days of termination of pregnancy"(Ninama et al., 2022) High risk pregnancy is defined as one where pregnancy is complicated by factor or factors that adversely affects the outcome- maternal or perinatal or both. Women with high-risk pregnancies should receive care from a special team of health care providers to ensure the best possible outcomes. (Arjariya \& Tiwari, .2021) .High-risk pregnancy was classified based on the guidelines provided by Pradhan Mantri Surakshit Matritva Abhiyan (PMSMA) for identification of high-risk pregnancy by health-care workers. The parameters considered for diagnosis of high- risk pregnancy were also defined as per the guidelines provided by PMSMA. Antenatal women with the following conditions were categorized under high-risk pregnancy: a. Severe anemia with hemoglobin level 140/90 mmHg) b. Hypertensive disorder in pregnancy (blood pressure >140/90 mmHg) c. Previous history of lower segment cesarean section d. Bad obstetric history (history of obstructed labor) e. Low-lying placenta or placenta previa. .(Arjariya \& Tiwari.,2021)
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- all nurses
Key inclusion criteria (1 listed)
- all nurses staff
Key exclusion criteria (1 listed)
- nurses who refuse participation
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 |
|---|---|---|
| assess the nurse knowledge and practices.assess the nurse knowledge and practices. | Other | – |
Primary outcome
Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training
Time frame: 10 months
Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Pregnancy and Maternal Near Miss Cases, run by Sohag University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 16 Feb 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training (time frame: 10 months). 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 16 Feb 2024.