- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07564856
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Al-Qalyubia Governorate
-
Banhā, Al-Qalyubia Governorate, Ägypten, 13511
- Obstetrics and Gynecology Outpatient Clinic, Benha University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pregnancy-Specific Climate Change Knowledge
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Climate-Related Health Beliefs
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Eman Atef Elsokary, PhD, Faculty of Nursing, Helwan University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HUNURSERC-2025-07-52-09
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .