CClinicalTrials.gg
CompletedNCT07564856Updated May 4, 2026

Climate-Safe Pregnancy Intervention for Women With Preeclclampsia

An interventional study of Climate-Related Nursing Intervention and Routine Antenatal Care in Preeclampsia, Pregnancy Complications and Climate Change and Maternal Health, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Benha University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

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.

02

Conditions studied

  • Preeclampsia
  • Pregnancy Complications
  • Climate Change and Maternal Health

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
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 104 is close to the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Pregnant women diagnosed with mild or moderate preeclampsia
  2. Gestational age between 20 and 34 weeks
  3. Age between 18 and 45 years
  4. Singleton pregnancy
  5. Able to read and communicate effectively
  6. Willing to participate and provide informed consent

Exclusion criteria

Exclusion Criteria:

  1. Severe preeclampsia requiring immediate hospitalization
  2. Presence of chronic medical disorders such as renal disease, cardiac disease, or autoimmune disorders
  3. Multiple pregnancy
  4. Diagnosed psychiatric illness or cognitive impairment affecting participation
  5. Participation in another structured educational intervention during the study period
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    Intervention

    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.

    Behavioral: Climate-Related Nursing Intervention

  • Active comparator
    Control Group

    Participants receive routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up.

    Other: Routine Antenatal Care

Interventions

  • BehavioralClimate-Related Nursing Intervention

    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.

  • OtherRoutine Antenatal Care

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up

Secondary outcomes

  1. 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.

    Time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up

  2. 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.

    Time frame: Baseline, 2 weeks post-intervention, and 4 weeks follow-up

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Study locations

1 site
  • Obstetrics and Gynecology Outpatient Clinic, Benha University Hospital
    Banhā, Al-Qalyubia Governorate 13511, Egypt
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07564856
Lead sponsor
Benha University
Collaborators
Helwan University
Responsible party
Eman Atef Elsokary (Assistant professor of Maternal and Newborn Health Nursing, Benha University) — Principal investigator
First posted
May 4, 2026
Start date
Jul 1, 2025
Primary completion
Dec 29, 2025
Completion
Dec 29, 2025
Last update
May 4, 2026

Study contacts

Eman Atef Elsokary, PhD
principal investigator · Faculty of Nursing, Helwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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