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Survey of Women's Choice of Delivery Before Consulting With Her Obstetrician

24. maj 2017 opdateret af: University of California, Davis

Understanding a Woman's Choice of Mode of Delivery Before Initial Consult With Her Obstetrician After Having One Prior Cesarean Section

We are surveying women who have had a previous cesarean section at the time of entry into prenatal care for their next pregnancy about their thoughts related to a trial of labor after cesarean (TOLAC) or repeat c-section.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a survey for women who have had a previous cesarean section, also known as a c-section, with their last pregnancy. The study is looking at what factors and people may influence the decisions women make about their birthing plan after they have had a previous c-section. If they qualify, women will be asked to complete a brief survey at their initial Ob/Gyn appointment before they see their Ob doctor. In order to qualify, women must:

  • Be pregnant
  • Have not seen an obstetrician for this pregnancy
  • Be at least 18 years old
  • Be able to read English
  • Have had a prior pregnancy delivered by c-section
  • Only had one prior c-section
  • The c-section must have been the last pregnancy before this one

Questions that will be asked include:

  • Demographic information (examples: age, race/ethnicity)
  • Pregnancy information
  • Delivery questions
  • Factors that may influence her birthing plan

Participants will also be asked if the study staff can follow up after her delivery to see what kind of delivery she had (vaginal or c-section).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

8

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95817
        • University of California, Davis Department of Obstetrics and Gynecology

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will be selected from the new obstetrics patients in the University of California, Davis Department of Obstetrics and Gynecology department clinics.

Beskrivelse

Inclusion Criteria:

  • Pregnant Women
  • 18 years old or older
  • Prior pregnancy with cesarean delivery
  • No prior obstetric physician care during current pregnancy

Exclusion Criteria:

  • More than one prior cesarean
  • Women who cannot read English

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Women with a prior cesarean section
Survey of women who had a cesarean section with their last pregnancy and no other prior cesarean section deliveries
Andet: Undersøgelse
Undersøgelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant Opinions of mode of delivery as compared to actual mode of delivery
Tidsramme: Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)
Mode of delivery
Mode of delivery will be assessed after delivery, average 40 weeks gestational age (7-9 months after enrollment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Factors that influence participant's opinion of mode of delivery
Tidsramme: Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.
Participants will be asked what influences their opinions of mode of delivery, such as significant other, clinicians, family, friends, or others. They will also be asked how much these factors may influence their decisions (high influence, some influence, no influence).
Collected at time of study enrollment, typically 4-12 weeks into the subject's pregnancy.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trust of information they receive
Tidsramme: Collected at study enrollment, typically 4-12 weeks into the subject's pregnancy.
Participants will be asked if they trust the information that they receive from influencing factors, such as significant others, clinicians, family, friends, or other.
Collected at study enrollment, typically 4-12 weeks into the subject's pregnancy.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Davis

Efterforskere

  • Ledende efterforsker: Maricela Rangel-Garcia, University of California, Davis
  • Studieleder: Mitchell Creinin, MD, University of California, Davis

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. september 2013

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

27. september 2013

Først indsendt, der opfyldte QC-kriterier

9. december 2013

Først opslået (Skøn)

13. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 477211

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

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