Clinical trial NCT03073434: Pregnancy Outcomes in Renal Transplant Recipients
Official title: Pregnancy Outcomes in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplant
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Maternal health outcomes obtained from patient medical record
timeFrame: From start of pregnancy (1 week gestation) to 6 weeks post-partum
measure: Fetal and neo-natal health outcomes obtained from patient medical record
timeFrame: From start of pregnancy (1 week gestation) to 6 weeks post-partum
measure: Placental outcomes obtained from patient medical record
timeFrame: Measured immediately after delivery
measure: Transplant-related outcomes obtained from patient medical record
timeFrame: From start of pregnancy (1 week gestation) to 6 weeks post-partum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Howard Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: