PreeclampsiaNCT07564856
Climate-Safe Pregnancy Intervention for Women With Preeclclampsia
A study testing Climate-Related Nursing Intervention and Routine Antenatal Care in people with Preeclampsia and Pregnancy Complications, run by Benha University at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of a climate-related nursing intervention in improving pregnancy-specific climate change knowledge, health beliefs, and protective behaviors among pregnant women diagnosed with preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Pregnancy Complications, Climate Change and Maternal Health
- What is being tested?
- Climate-Related Nursing Intervention and Routine Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 29 Dec 2025
- 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 diagnosed with mild or moderate preeclampsia
- Gestational age between 20 and 34 weeks
- Age between 18 and 45 years
- Singleton pregnancy
- Able to read and communicate effectively
- Willing to participate and provide informed consent
Who cannot join
- Severe preeclampsia requiring immediate hospitalization
- Presence of chronic medical disorders such as renal disease, cardiac disease, or autoimmune disorders
- Multiple pregnancy
- Diagnosed psychiatric illness or cognitive impairment affecting participation
- Participation in another structured educational intervention during the study period
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics and Gynecology Outpatient Clinic, Benha University Hospital
Banhā, Al-Qalyubia Governorate, 13511
About this study
Official title: A Climate-Related Nursing Intervention to Improve Knowledge, Health Beliefs, and Protective Behaviors in Women With Preeclampsia: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of a climate-related nursing intervention in improving pregnancy-specific climate change knowledge, health beliefs, and protective behaviors among pregnant women diagnosed with preeclampsia. Climate change, particularly extreme heat exposure and air pollution, increases maternal and fetal health risks and may worsen hypertensive disorders of pregnancy such as preeclampsia. Despite growing evidence linking climate-related exposures to adverse pregnancy outcomes, there is limited intervention research addressing climate adaptation in high-risk pregnant women.
A total of 104 pregnant women with preeclampsia receiving antenatal care at Benha University Hospitals, Egypt, were randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group received routine antenatal care plus a structured nursing educational program entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia," while the control group received routine antenatal care alone.
Read more
The intervention included an individualized core educational session, structured educational materials, and a booster follow-up session. Outcomes were assessed at baseline, post-intervention, and follow-up using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS), the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), and the Climate Change Health Protection Behaviors Scale (CCHPB).
The study aims to provide evidence for theory-based nursing interventions that support maternal adaptation to climate-related health risks and improve antenatal care outcomes for women with preeclampsia.
Read the detailed description
This study is a two-arm, parallel-group randomized controlled trial conducted to evaluate the effectiveness of a structured climate-related nursing intervention for pregnant women diagnosed with preeclampsia. The study was conducted at the antenatal outpatient clinic of Benha University Hospitals, Egypt, between July and December 2025. Preeclampsia is a major hypertensive disorder of pregnancy associated with significant maternal and fetal morbidity. Climate-related exposures such as extreme heat, dehydration, air pollution, and environmental stressors may further increase maternal vulnerability and worsen pregnancy outcomes. Despite growing evidence linking climate change to adverse obstetric outcomes, there is limited intervention research addressing climate adaptation among women with preeclampsia, particularly in low- and middle-income countries.
A total of 104 eligible pregnant women diagnosed with preeclampsia were recruited and randomly allocated in a 1:1 ratio into intervention and control groups using computer-generated block randomization with sealed opaque envelope allocation concealment. The intervention group received routine antenatal care in addition to a structured nursing intervention entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia." The intervention included an individualized 45-minute core educational session covering climate-related maternal risks, protective behaviors, problem-solving strategies, and self-efficacy enhancement, followed by structured educational materials and a booster reinforcement session delivered after 10 days.
The control group received routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up. The primary outcome was pregnancy-specific climate change knowledge measured using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS). Secondary outcomes included climate-related health beliefs measured using the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), and climate change health protection behaviors measured using the Climate Change Health Protection Behaviors Scale (CCHPB).
Outcome measures were assessed at baseline, post-intervention, and four-week follow-up. The study aimed to generate evidence for theory-based nursing interventions that improve maternal adaptation to climate-related health risks and strengthen antenatal care outcomes for women with preeclampsia.
- Being tested
- Climate-Related Nursing Intervention, Routine Antenatal Care
- Keywords
- Preeclampsia, Climate Change, Pregnancy-Specific Climate Change Awareness, Health Belief Model, Nursing Intervention, Maternal Health, Protective Behaviors, Randomized Controlled Trial, High-Risk Pregnancy, Antenatal Care
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Climate-Related Nursing InterventionBehavioural
A structured educational nursing intervention designed to improve pregnancy-specific climate change knowledge, health beliefs, and protective behaviors among women with preeclampsia. The intervention includes a 45-minute individualized educational session, educational materials, a personalized climate-safe pregnancy plan, and a booster reinforcement session delivered after 10 days.
Routine Antenatal CareOther
Standard antenatal care for women with preeclampsia including clinical monitoring, blood pressure assessment, medication management, laboratory investigations as indicated, and routine counseling regarding warning signs, medication adherence, and scheduled follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive routine antenatal care plus a structured climate-related nursing intervention entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia," including an individualized educational session, structured educational materials, and a booster follow-up session. Receives: Behavioral: Climate-Related Nursing Intervention |
| Control Group | Active comparator | Participants receive routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up. Receives: Other: Routine Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-Specific Climate Change Knowledge
Pregnancy-specific climate change knowledge measured using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS), a 21-item validated instrument assessing general climate change awareness, maternal health awareness, and fetal health awareness. Higher scores indicate greater awareness and knowledge regarding climate-related maternal and fetal risks.
Measured: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
Secondary outcomes (2)
Climate-Related Health Beliefs
Climate-related health beliefs measured using the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), a 25-item scale assessing perceived susceptibility, perceived severity, perceived benefits, perceived barriers, and self-efficacy related to climate-related pregnancy risks. Higher scores indicate more favorable health beliefs.
Measured: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
Climate Change Health Protection Behaviors
Climate change health protection behaviors measured using the Climate Change Health Protection Behaviors Scale (CCHPB), a 28-item instrument assessing behaviors related to obtaining climate-related health information, protective actions during climate-related events, post-event protective behaviors, and climate change mitigation practices. Higher scores indicate better health protection behaviors.
Measured: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jul 2025
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group using computer-generated block randomization. The intervention group received routine antenatal care plus a structured climate-related nursing intervention, while the control group received routine antenatal care alone. Outcomes were assessed at baseline, post-intervention, and four-week follow-up.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University
- Responsible party
- Principal investigator, Eman Atef Elsokary, Benha University
- Investigators
- Eman Atef Elsokary, PhD, Principal investigator, Faculty of Nursing, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564856
- Sponsor's protocol ID
- HUNURSERC-2025-07-52-09
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is currently undecided. Data availability will be considered after study completion, publication of the primary results, and institutional approval, while ensuring participant confidentiality and compliance with ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Climate-Related Nursing Intervention to Improve Knowledge, Health Beliefs, and Protective Behaviors in Women With Preeclampsia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07564856
- Acronym / sponsor ID
- HUNURSERC-2025-07-52-09
- Keywords
- Preeclampsia, Climate Change, Pregnancy-Specific Climate Change Awareness, Health Belief Model, Nursing Intervention, Maternal Health, Protective Behaviors, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Helwan University
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 4 May 2026 (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.
This randomized controlled trial aims to evaluate the effectiveness of a climate-related nursing intervention in improving pregnancy-specific climate change knowledge, health beliefs, and protective behaviors among pregnant women diagnosed with preeclampsia. Climate change, particularly extreme heat exposure and air pollution, increases maternal and fetal health risks and may worsen hypertensive disorders of pregnancy such as preeclampsia. Despite growing evidence linking climate-related exposures to adverse pregnancy outcomes, there is limited intervention research addressing climate adaptation in high-risk pregnant women.
A total of 104 pregnant women with preeclampsia receiving antenatal care at Benha University Hospitals, Egypt, were randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group received routine antenatal care plus a structured nursing educational program entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia," while the control group received routine antenatal care alone.
The intervention included an individualized core educational session, structured educational materials, and a booster follow-up session. Outcomes were assessed at baseline, post-intervention, and follow-up using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS), the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), and the Climate Change Health Protection Behaviors Scale (CCHPB).
The study aims to provide evidence for theory-based nursing interventions that support maternal adaptation to climate-related health risks and improve antenatal care outcomes for women with preeclampsia.
Detailed description
This study is a two-arm, parallel-group randomized controlled trial conducted to evaluate the effectiveness of a structured climate-related nursing intervention for pregnant women diagnosed with preeclampsia. The study was conducted at the antenatal outpatient clinic of Benha University Hospitals, Egypt, between July and December 2025. Preeclampsia is a major hypertensive disorder of pregnancy associated with significant maternal and fetal morbidity. Climate-related exposures such as extreme heat, dehydration, air pollution, and environmental stressors may further increase maternal vulnerability and worsen pregnancy outcomes. Despite growing evidence linking climate change to adverse obstetric outcomes, there is limited intervention research addressing climate adaptation among women with preeclampsia, particularly in low- and middle-income countries.
A total of 104 eligible pregnant women diagnosed with preeclampsia were recruited and randomly allocated in a 1:1 ratio into intervention and control groups using computer-generated block randomization with sealed opaque envelope allocation concealment. The intervention group received routine antenatal care in addition to a structured nursing intervention entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia." The intervention included an individualized 45-minute core educational session covering climate-related maternal risks, protective behaviors, problem-solving strategies, and self-efficacy enhancement, followed by structured educational materials and a booster reinforcement session delivered after 10 days.
The control group received routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up. The primary outcome was pregnancy-specific climate change knowledge measured using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS). Secondary outcomes included climate-related health beliefs measured using the Health Belief Model-Based Climate Change and Preeclampsia Scale (HBM-CCP), and climate change health protection behaviors measured using the Climate Change Health Protection Behaviors Scale (CCHPB).
Outcome measures were assessed at baseline, post-intervention, and four-week follow-up. The study aimed to generate evidence for theory-based nursing interventions that improve maternal adaptation to climate-related health risks and strengthen antenatal care outcomes for women with preeclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group using computer-generated block randomization. The intervention group received routine antenatal care plus a structured climate-related nursing intervention, while the control group received routine antenatal care alone. Outcomes were assessed at baseline, post-intervention, and four-week follow-up.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Climate-Related Nursing InterventionParticipants receive routine antenatal care plus a structured climate-related nursing intervention entitled "Climate-Safe Pregnancy: Adaptation and Self-Protection Guidelines for Women with Preeclampsia," including an individualized educational session, structured educational materials, and a booster follow-up session. |
| Control Group | Active comparator | Other: Routine Antenatal CareParticipants receive routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women diagnosed with mild or moderate preeclampsia
- Gestational age between 20 and 34 weeks
- Age between 18 and 45 years
- Singleton pregnancy
- Able to read and communicate effectively
Key exclusion criteria (5 listed)
- Severe preeclampsia requiring immediate hospitalization
- Presence of chronic medical disorders such as renal disease, cardiac disease, or autoimmune disorders
- Multiple pregnancy
- Diagnosed psychiatric illness or cognitive impairment affecting participation
- Participation in another structured educational intervention during the study period
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 |
|---|---|---|
| Climate-Related Nursing InterventionA structured educational nursing intervention designed to improve pregnancy-specific climate change knowledge, health beliefs, and protective behaviors among women with preeclampsia. The intervention includes a 45-minute individualized educational session, educational materials, a personalized climate-safe pregnancy plan, and a booster reinforcement session delivered after 10 days. | Behavioural | Intervention |
| Routine Antenatal CareStandard antenatal care for women with preeclampsia including clinical monitoring, blood pressure assessment, medication management, laboratory investigations as indicated, and routine counseling regarding warning signs, medication adherence, and scheduled follow-up visits. | Other | Control Group |
Primary outcome
Pregnancy-Specific Climate Change Knowledge
Time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
Pregnancy-specific climate change knowledge measured using the Pregnancy-Specific Climate Change Awareness Scale (PSCCAS), a 21-item validated instrument assessing general climate change awareness, maternal health awareness, and fetal health awareness. Higher scores indicate greater awareness and knowledge regarding climate-related maternal and fetal risks.
2 secondary outcomes
Climate-Related Health Beliefs
Time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
Climate Change Health Protection Behaviors
Time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
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 4 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is currently undecided. Data availability will be considered after study completion, publication of the primary results, and institutional approval, while ensuring participant confidentiality and compliance with ethical and regulatory requirements.
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Eman Atef Elsokary, PhD principal investigator
Faculty of Nursing, Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Climate-Related Nursing Intervention and Routine Antenatal Care in people with Preeclampsia and Pregnancy Complications, run by Benha 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 6 inclusion and 5 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 4 May 2026. 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?
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?
Pregnancy-Specific Climate Change Knowledge (time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up). 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 4 May 2026.