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Clinical Trials/NCT05461183
NCT05461183
Unknown
Not Applicable

Assessment of Cumulative Incidence and Factors Associated With Hospital Re-admission and Severe Maternal Morbidity After Delivery Discharge in British Columbia

University of British Columbia0 sites15,000 target enrollmentApril 1, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbidity;Perinatal
Sponsor
University of British Columbia
Enrollment
15000
Primary Endpoint
Maternal hospital readmission
Last Updated
3 years ago

Overview

Brief Summary

For every case of maternal death, many more women experience life-threatening complications during pregnancy and childbirth. Yet, severe maternal morbidity (SMM) cases are often overlooked post-delivery. Women have reported that roughly 15% of SMM cases first occurred in the six weeks following delivery. The underlying factors associated with these morbidities are likely different than those occurring antenatally and at the time of delivery. Further research is required to elucidate the exact burden of SMM in the postpartum period in British Columbia (BC).

Detailed Description

The ratio of maternal morbidity to maternal mortality is increasing globally (Geller 2018). In high-income countries, the World Health Organization (WHO) recommends routinely surveilling SMM to assess maternal health and quality of care (Geller 2018). To our knowledge, this is the first study conducted among pregnancies in BC aiming to examine the cumulative incidence, timing, and factors associated with postpartum maternal morbidity and hospital readmissions. This is a retrospective cohort study will use data from the BC Perinatal Data Registry (BCPDR), which contains maternal, fetal and neonatal health information from 99% of all deliveries in BC. The primary outcome assessed will be the cumulative incidence of hospital readmissions and SMM events occurring after delivery discharge within the first six weeks (42 days) of delivery. Secondary outcomes will include SMM-diagnosis, the rate and timing of postpartum SMM and readmissions, and maternal characteristics associated with these events. A multinominal logistic regression model will examine the association between postpartum SMM or readmission and determinants.

Registry
clinicaltrials.gov
Start Date
April 1, 2008
End Date
January 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marianne Vidler

Assistant Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • Delivered in BC from April 1, 2008 to March 31, 2021
  • Consented to data collected by the BCPDR

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maternal hospital readmission

Time Frame: Up to six weeks post-delivery discharge

Cumulative incidence of women who get readmitted into the hospital after being discharged post-delivery

Severe maternal morbidity (SMM) event

Time Frame: Up to six weeks post-delivery discharge

Cumulative incidence of women who experience least one SMM event, defined as: severe pre-eclampsia, HELLP, eclampsia; severe haemorrhage; maternal ICU admission; surgical complications; hysterectomy; sepsis; embolism, shock, DIC; assisted ventilation; cardiac conditions; acute renal failure; several uterine rupture; cerebrovascular accidents; and other types of maternal morbidity.

Secondary Outcomes

  • Timing of hospital readmission and SMM events(Up to six weeks postpartum)
  • SMM type(Up to six weeks postpartum)
  • Rate of hospital readmission and SMM events(Up to six weeks postpartum)
  • Maternal characteristics(Up to six weeks postpartum)

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