Internet-based Study of Fertility and Early Pregnancy (PEEPS) (PEEPS)
26. oktober 2015 opdateret af: Courtney D.Lynch, PhD MPH
Prospective Evaluation of the Elements of Pregnancy Study
The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss.
Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out.
The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period.
We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant.
Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal use over time.
We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment.
The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
161
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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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University College of Medicine
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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
18 år til 44 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
We are looking for women ages 18-44 who are planning a pregnancy and have been trying to conceive for <3 months.
Women must have reliable daily access to the Internet.
The woman and her male partner may not have any known fertility problems.
Beskrivelse
Inclusion Criteria:
- Women
- Ages 18-44
- In a stable relationship
- Sexually active with a male partner
- Reliable daily access to the Internet
Exclusion Criteria:
- Woman or her partner has a known fertility problem
- Trying to conceive for three or more months.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Women who are trying to conceive
Women ages 18-44 without a history of fertility problems who are in a stable relationship with a male partner who have regular access to the Internet and have been trying to conceive <3 months.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number enrolled
Tidsramme: One year
|
One year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Completeness of data collection
Tidsramme: Following 9-21 months of data collection
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Percentage of the study that the participant completed: baseline questionnaire (Y/N); daily trying to conceive journals (%); weekly pregnancy journals (%); and delivery information (%).
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Following 9-21 months of data collection
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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
1. juli 2013
Primær færdiggørelse (Faktiske)
1. august 2015
Studieafslutning (Faktiske)
1. august 2015
Datoer for studieregistrering
Først indsendt
15. juli 2013
Først indsendt, der opfyldte QC-kriterier
17. juli 2013
Først opslået (Skøn)
22. juli 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. oktober 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. oktober 2015
Sidst verificeret
1. oktober 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012H0128
- 1R03HD073504-01 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .