Climate-Safe Pregnancy Intervention for Women With Preeclclampsia

NCT07564856 | Completed

• 1 other identifier: HUNURSERC-2025-07-52-09
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  Baseline, 2 weeks post-intervention, and 4 weeks follow-up

Secondary Outcomes (2)

• Climate-Related Health Beliefs

  Baseline, 2 weeks post-intervention, and 4 weeks follow-up

• Climate Change Health Protection Behaviors

  Baseline, 2 weeks post-intervention, and 4 weeks follow-up

Study Arms (2)

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.

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.

Other: Routine Antenatal Care

Interventions

Climate-Related Nursing Intervention BEHAVIORAL

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.

Intervention

Routine Antenatal Care OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead
• Helwan University: collaborator

Study Sites (1)

Obstetrics and Gynecology Outpatient Clinic, Benha University Hospital

Banhā, Al-Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eman Atef Elsokary, PhD

  Faculty of Nursing, Helwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial. Due to the nature of the educational nursing intervention, blinding of participants, care providers, and investigators was not feasible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Maternal and Newborn Health Nursing

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: July 1, 2025
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

EG (1)