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Pregnancy Outcomes in Renal Transplant Recipients

28. april 2020 opdateret af: Unity Health Toronto

This is a retrospective study involving all patients with a history of renal transplant that attended antenatal clinics at various Toronto hospitals and subsequently delivered between January 2000 and December 2014.

The purpose of this study is to describe the incidence of adverse pregnancy-and transplant-related outcomes, and report placental ultrasound and placental pathology findings in renal transplant recipients with contemporary standards of care in Toronto.

This study also seeks to determine whether factors such as maternal age, transplant-to-pregnancy interval, hypertension, diabetes mellitus, treatment regimens, and the primary cause for renal failure are associated with higher risk of adverse pregnancy outcomes in renal transplant recipients.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Adverse pregnancy outcomes in women with renal transplants have been attributed to a number of factors. A recent systematic review suggested an association between maternal age and adverse pregnancy outcomes such as miscarriage and stillbirth. There are also some data to suggest that maternal hypertension, diabetes mellitus, elevated serum creatinine and proteinuria and some medications such as cyclosporine are associated with adverse pregnancy outcomes such as preeclampsia, intrauterine growth restriction and preterm delivery.There is no consensus on whether the transplant-to-pregnancy interval is associated with adverse pregnancy outcomes. As well, it is not clear if the findings of other studies will also hold true in a Toronto population.

This study seeks to answer the following questions:

  1. What is the incidence of adverse transplant- and pregnancy-related adverse outcomes in renal transplant recipients that have had pregnancies between 2000 and 2014 in Toronto and how does this compare with earlier data from Toronto and with recently published data?
  2. Are factors such as maternal age, transplant-to-pregnancy interval, hypertension, diabetes mellitus, specific treatment regimens and the primary cause for renal failure associated with an increased risk of adverse pregnancy- and transplant-related adverse outcomes in these women?

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

17

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All patients with a history of renal transplant that attended antenatal clinics at Mt. Sinai Hospital, Sunnybrook Health Sciences Centre and St.Michael's hospital and subsequently delivered between January 2000 and December 2014.

Beskrivelse

Inclusion Criteria:

  • All patients with a history of renal transplant that attended antenatal clinics at Mt. Sinai Hospital, Sunnybrook Health Sciences Centre and St. Michael's hospital and subsequently delivered between January 2000 and December 2014

Exclusion Criteria:

  • Patients who do not meet the above criteria are excluded from the sample

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal health outcomes obtained from patient medical record
Tidsramme: From start of pregnancy (1 week gestation) to 6 weeks post-partum
Observed health outcomes of the mother after giving birth, obtained retrospectively from the patient's medical record.
From start of pregnancy (1 week gestation) to 6 weeks post-partum
Fetal and neo-natal health outcomes obtained from patient medical record
Tidsramme: From start of pregnancy (1 week gestation) to 6 weeks post-partum
Observed health outcomes of the fetus/neonate after delivery, obtained retrospectively from the patient's medical record.
From start of pregnancy (1 week gestation) to 6 weeks post-partum
Placental outcomes obtained from patient medical record
Tidsramme: Measured immediately after delivery
Biochemistry and physical characteristics of the placenta, obtained retrospectively from the patient's medical record.
Measured immediately after delivery
Transplant-related outcomes obtained from patient medical record
Tidsramme: From start of pregnancy (1 week gestation) to 6 weeks post-partum
Graft function during pregnancy and at end of pregnancy, obtained retrospectively from the patient's medical record.
From start of pregnancy (1 week gestation) to 6 weeks post-partum

Samarbejdspartnere og efterforskere

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

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)

1. marts 2016

Primær færdiggørelse (Forventet)

1. marts 2022

Studieafslutning (Forventet)

1. marts 2022

Datoer for studieregistrering

Først indsendt

13. februar 2017

Først indsendt, der opfyldte QC-kriterier

2. marts 2017

Først opslået (Faktiske)

8. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15-289

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

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Kliniske forsøg med Nyretransplantation

3
Abonner