Prematurity Education in High Risk Pregnancies
3. juni 2020 opdateret af: Rebecca Fish, University Hospitals Cleveland Medical Center
Early Education of Prematurity in High Risk Pregnancies-A Pilot Study
Prematurity is associated with significant morbidity and mortality.
Given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child.
Unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult.
This study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
76
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- UH Cleveland Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery.
- Premature delivery defined as <37 0/7 weeks gestation.
- Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at high risk for premature delivery.
- Pregnant women 16 years and older.
- Pregnancy with singleton or twin gestation.
- No major congenital malformation.
- Women who are English speaking.
Exclusion Criteria:
- Pregnant women <22 0/7 or >35 0/7 weeks gestational age.
- Pregnant women less than 16 years old.
- Multiple gestation greater than twins (triplets, quadruplets, etc).
- Known major congenital malformation.
- Women who are non-English speaking.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Early counseling of prematurity in high-risk pregnancies
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Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.
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Ingen indgriben: Standard counseling of prematurity in high-risk pregnancies
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Parental knowledge of prematurity.
Tidsramme: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
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Questionnaire to assess parental knowledge regarding basic concepts of prematurity, associated complications and factors that improve survival.
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Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
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Parental satisfaction with prematurity education.
Tidsramme: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
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Survey to assess usefulness of web-based educational tool and satisfaction with early education of prematurity.
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Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
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Parental anxiety.
Tidsramme: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
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Evaluation of parental anxiety associated with prematurity using validated six-item short-form of the Spielberger State-Trait Anxiety Inventory (STAI).
The State-Trait Anxiety Inventory (STAI) measures presence and severity of anxiety.
The inventory consists of two self-reporting subscales that evaluate the current state of anxiety (state anxiety subscale), as well as the propensity towards being anxious (trait anxiety subscale).
The range for total score is 20-80, with a higher score indicating greater anxiety.
The six-item version of the Spielberger State-Trait Anxiety Inventory (STAI: Y-6 item) is composed of three-questions from the original state anxiety subscale and three-questions from the original trait anxiety subscale.
This shortened six-item inventory is a reliable and valid instrument when compared to the full forty-question inventory.
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Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maternal compliance with maternal-fetal medicine provider follow up.
Tidsramme: Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.
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Frequency of no show and cancelled appointments during remainder of pregnancy.
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Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rebecca A Fish, MD, UH, Cleveland Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. november 2018
Primær færdiggørelse (Faktiske)
3. december 2019
Studieafslutning (Faktiske)
9. marts 2020
Datoer for studieregistrering
Først indsendt
1. november 2018
Først indsendt, der opfyldte QC-kriterier
7. december 2018
Først opslået (Faktiske)
11. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY20180789
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Præmaturitet
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Roberta BallardMallinckrodt; ONYAfsluttetBronkopulmonal dysplasi | Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction)Forenede Stater