Pregnancy Outcomes in Renal Transplant Recipients

NCT03073434 | Unknown

• 1 other identifier: 15-289
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Officials

• Howard Berger, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 8, 2017
• Study Start: March 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share