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Climate-Safe Pregnancy Intervention for Women With Preeclclampsia

2026년 4월 27일 업데이트: Eman Atef Elsokary, Benha University

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

104

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.
활성 비교기: Control Group
Participants receive routine antenatal care only, including standard monitoring, medication management, and routine counseling regarding preeclampsia and antenatal follow-up.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pregnancy-Specific Climate Change Knowledge
기간: 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.
Baseline, 2 weeks post-intervention, and 4 weeks follow-up

2차 결과 측정

결과 측정
측정값 설명
기간
Climate-Related Health Beliefs
기간: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
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
기간: Baseline, 2 weeks post-intervention, and 4 weeks follow-up
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Eman Atef Elsokary, PhD, Faculty of Nursing, Helwan University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 1일

기본 완료 (실제)

2025년 12월 29일

연구 완료 (실제)

2025년 12월 29일

연구 등록 날짜

최초 제출

2026년 4월 27일

QC 기준을 충족하는 최초 제출

2026년 4월 27일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 27일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • HUNURSERC-2025-07-52-09

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .