Hypertensive Disorders of PregnancyEducaTHENCT05837962
Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy
A study testing Nursing intervention to improve knowledge and self-care behaviors in the face of HDP in people with Hypertensive Disorders of Pregnancy, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy
- What is being tested?
- Nursing intervention to improve knowledge and self-care behaviors in the face of HDP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- 10 Apr 2023to 28 Dec 2023
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women enrolled in the prenatal care program of a health institution
- Pregnant women aged 18 years or older
- Pregnant women with a gestational age equal to or less than 24 weeks determined by the date of the last period or obstetric ultrasound.
- Pregnant women residing in the urban area.
Who cannot join
- Pregnant women with chronic conditions such as heart disease, renal disease, or diabetes mellitus.
- Pregnant women with a history or diagnosis at entry or during the study of HDP according to the classification of the American College of Obstetricians and Gynecologists (ACOG)
- Pregnant women who are participating in other educational studies or workshops/programs with similar themes to this study.
- Pregnant women scoring less than 24 points on the Mini-mental status test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of the Nursing Intervention "EducaTHE" to Improve Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy in Pregnant Women.
Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. This is a randomized controlled pilot trial type study, with a control group that will receive the usual prenatal care and an intervention group that will additionally receive the nursing intervention to improve knowledge and self-care behaviors in the face of HDP. Each group will include 30 pregnant women, for a total of 60 users. The level of knowledge and self-care behaviors will be assessed before and after the intervention.
Read the detailed description
Introduction: the World Health Organization (WHO) indicates that HDP are the third leading cause of maternal death worldwide; and in Latin America and the Caribbean they are positioned as the first cause. The evidence has described that limited or non-existent knowledge and the lack of self-care behaviors by the pregnant woman in the face of HDP are important conditions in the incidence of this obstetric complication. In this sense, nursing must design and implement intervention strategies that have a positive impact on knowledge and self-care behaviors in the face of HDP.
Objective: to determine the feasibility and acceptability of the "EducaTHE" nursing intervention to improve knowledge and self-care behaviors in the face of hypertensive disorders of pregnancy in pregnant women.
Methods: randomized controlled pilot trial experimental study with pregnant women assigned to an intervention group and a control group. The sample will consist of a total of 40 pregnant women, 20 in each of the study groups.
The intervention group will receive the usual education of prenatal control. The control group, in addition to the usual prenatal control information, will receive an educational, behavioral and motivational intervention related to HDP and their self-care behaviors. The intervention will be carried out in 4 sessions, on a weekly basis, in a face-to-face and group. In both groups, knowledge and self-care behaviors will be measured before and 4 weeks after the end of the intervention.
Randomization: the assignment will be carried out through a simple randomization process, with an intervention/control ratio 1:1, by means of a sequence of random numbers generated by a statistical program. The assignment will be given by one of the researchers who will not perform the intervention, nor the initial or final evaluation.
Expected results: feasibility and acceptability of the study in the context of perinatal maternal care
- Conditions
- Hypertensive Disorders of Pregnancy
- Being tested
- Nursing intervention to improve knowledge and self-care behaviors in the face of HDP
- Keywords
- Knowledge,Self Care,Pregnancy,Nursing, Feasibility Studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing intervention to improve knowledge and self-care behaviors in the face of HDPBehavioural
The nursing professional will perform 1 session weekly, for 4 weeks, lasting 90 minutes each. The contents that make up each of the sessions are:
Session 1. Knowledge about the risk factors, signs and symptoms, maternal and fetal complications of HDP.
Session 2. Control over behaviour, positive attitude and family and social support: essential components for conducting self-care behaviour.
Session 3. Nutritional recommendations: eating healthy helps prevent or reduce the risk of developing HDP.
Recommendations to improve sleep, rest and physical exercise: key routines in my health to prevent or reduce the risk of developing HDP.
Session 4. Mental health promotion: managing my stress, anxiety and depression levels help prevent or decrease the risk of HDP
| Study group | Role | What they receive |
|---|---|---|
| Nursing intervention to improve knowledge and self-care behaviors in the face of HDP | Experimental | Behavioral: Educational, behavioral and motivational intervention developed by nurses aimed at improving the level of knowledge and self-care behaviors of pregnant women in the face of HDP. Receives: Behavioral: Nursing intervention to improve knowledge and self-care behaviors in the face of HDP |
| Usual management during prenatal care | No intervention | Behavioral: Nursing education about maternal care and usual education in maternity preparation course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: recruitment, attrition, follow-up
Recruitment For the analysis of this variable, the number of pregnant women enrolled in the prenatal control program of the health institution who meet the inclusion criteria of the study, and the number of pregnant women who agree to participate in the study, will be taken into account.
Attrition This variable will include the number of pregnant women who agreed to participate, and the number of participants who did not attend or did not complete the four sessions of the intervention.
Follow-up This variable will include the number of pregnant women who complete the four sessions of the intervention, and the number of participants who completed the study after the post-intervention measurements.
Measured: 6 months
Acceptability
A survey will be used to assess acceptability. The survey will be divided into three sessions, the first consisting of 13 items aimed at obtaining information related to the contents of the educational material, the activities and the form of delivery of the intervention, dose and interventionist. The second session consisted of 11 items that will evaluate the benefits and weaknesses of the intervention. The third contains 3 open questions related to the taste for the intervention, suggestions and recommendations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start10 Apr 2023
- Primary completion16 Aug 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edier Mauricio Arias Rojas, Universidad de Antioquia
- Investigators
- Edier Arias Rojas, Study director, Universidad de AntioquiaIliana Ulloa Sabogal, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837962
- Sponsor's protocol ID
- Acta No 234 CEI-FE
- Acronym
- EducaTHE
- Status last verified
- May 2024
- First submitted
- 2 Apr 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of the Nursing Intervention "EducaTHE" to Improve Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy in Pregnant Women.
- ClinicalTrials.gov ID
- NCT05837962
- Acronym / sponsor ID
- EducaTHE / Acta No 234 CEI-FE
- Conditions
- Hypertensive Disorders of Pregnancy
- Keywords
- Knowledge,Self Care,Pregnancy,Nursing, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 1 May 2023 (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.
Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. This is a randomized controlled pilot trial type study, with a control group that will receive the usual prenatal care and an intervention group that will additionally receive the nursing intervention to improve knowledge and self-care behaviors in the face of HDP. Each group will include 30 pregnant women, for a total of 60 users. The level of knowledge and self-care behaviors will be assessed before and after the intervention.
Detailed description
Introduction: the World Health Organization (WHO) indicates that HDP are the third leading cause of maternal death worldwide; and in Latin America and the Caribbean they are positioned as the first cause. The evidence has described that limited or non-existent knowledge and the lack of self-care behaviors by the pregnant woman in the face of HDP are important conditions in the incidence of this obstetric complication. In this sense, nursing must design and implement intervention strategies that have a positive impact on knowledge and self-care behaviors in the face of HDP.
Objective: to determine the feasibility and acceptability of the "EducaTHE" nursing intervention to improve knowledge and self-care behaviors in the face of hypertensive disorders of pregnancy in pregnant women.
Methods: randomized controlled pilot trial experimental study with pregnant women assigned to an intervention group and a control group. The sample will consist of a total of 40 pregnant women, 20 in each of the study groups.
The intervention group will receive the usual education of prenatal control. The control group, in addition to the usual prenatal control information, will receive an educational, behavioral and motivational intervention related to HDP and their self-care behaviors. The intervention will be carried out in 4 sessions, on a weekly basis, in a face-to-face and group. In both groups, knowledge and self-care behaviors will be measured before and 4 weeks after the end of the intervention.
Randomization: the assignment will be carried out through a simple randomization process, with an intervention/control ratio 1:1, by means of a sequence of random numbers generated by a statistical program. The assignment will be given by one of the researchers who will not perform the intervention, nor the initial or final evaluation.
Expected results: feasibility and acceptability of the study in the context of perinatal maternal care
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing intervention to improve knowledge and self-care behaviors in the face of HDP | Experimental | Behavioral: Nursing intervention to improve knowledge and self-care behaviors in the face of HDPBehavioral: Educational, behavioral and motivational intervention developed by nurses aimed at improving the level of knowledge and self-care behaviors of pregnant women in the face of HDP. |
| Usual management during prenatal care | No intervention | –Behavioral: Nursing education about maternal care and usual education in maternity preparation course |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women enrolled in the prenatal care program of a health institution
- Pregnant women aged 18 years or older
- Pregnant women with a gestational age equal to or less than 24 weeks determined by the date of the last period or obstetric ultrasound.
- Pregnant women residing in the urban area.
Key exclusion criteria (4 listed)
- Pregnant women with chronic conditions such as heart disease, renal disease, or diabetes mellitus.
- Pregnant women with a history or diagnosis at entry or during the study of HDP according to the classification of the American College of Obstetricians and Gynecologists (ACOG)
- Pregnant women who are participating in other educational studies or workshops/programs with similar themes to this study.
- Pregnant women scoring less than 24 points on the Mini-mental status test.
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 |
|---|---|---|
| Nursing intervention to improve knowledge and self-care behaviors in the face of HDPThe nursing professional will perform 1 session weekly, for 4 weeks, lasting 90 minutes each. The contents that make up each of the sessions are: Session 1. Knowledge about the risk factors, signs and symptoms, maternal and fetal complications of HDP. Session 2. Control over behaviour, positive attitude and family and social support: essential components for conducting self-care behaviour. Session 3. Nutritional recommendations: eating healthy helps prevent or reduce the risk of developing HDP. Recommendations to improve sleep, rest and physical exercise: key routines in my health to prevent or reduce the risk of developing HDP. Session 4. Mental health promotion: managing my stress, anxiety and depression levels help prevent or decrease the risk of HDP | Behavioural | Nursing intervention to improve knowledge and self-care behaviors in the face of HDP |
Primary outcome
Feasibility: recruitment, attrition, follow-up
Time frame: 6 months
Recruitment For the analysis of this variable, the number of pregnant women enrolled in the prenatal control program of the health institution who meet the inclusion criteria of the study, and the number of pregnant women who agree to participate in the study, will be taken into account. Attrition This variable will include the number of pregnant women who agreed to participate, and the number of participants who did not attend or did not complete the four sessions of the intervention. Follow-up This variable will include the number of pregnant women who complete the four sessions of the intervention, and the number of participants who completed the study after the post-intervention measurements.
Acceptability
Time frame: 6 months
A survey will be used to assess acceptability. The survey will be divided into three sessions, the first consisting of 13 items aimed at obtaining information related to the contents of the educational material, the activities and the form of delivery of the intervention, dose and interventionist. The second session consisted of 11 items that will evaluate the benefits and weaknesses of the intervention. The third contains 3 open questions related to the taste for the intervention, suggestions and recommendations
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 16 May 2024.
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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.
Edier Arias Rojas study director
Universidad de Antioquia
Iliana Ulloa Sabogal principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing intervention to improve knowledge and self-care behaviors in the face of HDP in people with Hypertensive Disorders of Pregnancy, run by Universidad de Antioquia at 1 site in Colombia.
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 4 inclusion and 4 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 16 May 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 Colombia. 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?
Feasibility: recruitment, attrition, follow-up (time frame: 6 months). The study lists 2 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 16 May 2024.