- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04385238
Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Millions of women will give birth during the pandemic of Coronavirus Disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The consequences of COVID-19 for pregnant women and their offspring are unknown. This lack of information leads to anxiety among pregnant women, women who are considering getting pregnant, and their families. It is therefore important to assess the wellbeing and mental health of women during the COVID-19 pandemic.
The international nature of the online survey will allow the evaluation of how living during the COVID-19 pandemic affects pregnant and recently pregnant women at a global level, including the evaluation of potential cultural and geographic differences.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90045
- Pregistry
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Pregnant women or women who have been pregnant within the last 6 months
- Able to give electronic informed consent
Exclusion Criteria:
- <18 years of age
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Gravid kvinde
Gravide kvinder, der er 18 år eller ældre.
|
Da dette er en online undersøgelse om sundhed og velvære, er der ingen intervention.
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Post-partum women
Women who gave birth within the last 6 months who are 18 years of age or older.
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Da dette er en online undersøgelse om sundhed og velvære, er der ingen intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Symptoms of Post-traumatic Stress Disorder
Tidsramme: Anytime during pregnancy or within 6 months after given birth.
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Post-traumatic Stress Disorder (PTSD) Symptoms will be assessed by the Impact of Events Scale-6.
This scale includes a total of six items: two items from each of the three subscales of the measure, namely intrusion, hyperarousal and avoidance.
Participants will be asked to report their PTSD symptoms in the past 7 days on a Likert Scale ranging from 0 (not at all) to 4 (extremely).
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Anytime during pregnancy or within 6 months after given birth.
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Number of Participants With Symptoms of Anxiety and Depression
Tidsramme: Anytime during pregnancy or within 6 months after given birth.
|
Symptoms of anxiety and depression will be measured by the Patient Health Questionnaire-4 (PHQ-4) which combines two ultrabrief screeners: the PHQ-2 and the Generalised Anxiety Disorder Scale.
Participants will be asked to report their symptoms of depression and anxiety in the past 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day) for a maximum score of 12.
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Anytime during pregnancy or within 6 months after given birth.
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karestan Koenen, PhD, Department of Epidemiology, Harvard T.H. Chan School of Public Health
- Studieleder: Sonia Hernandez-Diaz, MD, DrPh, Department of Epidemiology, Harvard T.H. Chan School of Public Health
- Studieleder: Diego Wyszynski, MD, MHS, PhD, Pregistry
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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