Climate-Safe Pregnancy Intervention for Women With Preeclclampsia

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.

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Preeclampsia; Climate Change and Maternal Health
• Intervention / Treatment: Behavioral: Climate-Related Nursing Intervention; Other: Routine Antenatal Care

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks post-intervention, and 4 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 2 weeks post-intervention, and 4 weeks follow-up

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: Helwan University
• Investigators: Principal Investigator: Eman Atef Elsokary, PhD, Faculty of Nursing, Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): December 29, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Preeclampsia; Health Belief Model; Antenatal Care; Maternal Health; Climate Change; High-Risk Pregnancy; Nursing Intervention; Pregnancy-Specific Climate Change Awareness; Protective Behaviors
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: HUNURSERC-2025-07-52-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No