Pregnancy Outcomes in Renal Transplant Recipients

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.

Study Overview

• Status: Unknown
• Conditions: Renal Transplant

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?

• Study Type: Observational
• Enrollment (Actual): 17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal health outcomes obtained from patient medical record	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	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	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	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

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 15-289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No