Clinical trial NCT05461183: Postpartum Outcomes in BC
Official title: Assessment of Cumulative Incidence and Factors Associated With Hospital Re-admission and Severe Maternal Morbidity After Delivery Discharge in British Columbia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbidity;Perinatal
Pregnancy Complications
Pregnancy Related
Keywords: severe maternal morbidity
postpartum period
hospital readmission
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Women's Health Research Institute of British Columbia
First posted: 2022-07-18
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who delivered between April 1, 2008 to March 31, 2021 using data from the BC Perinatal Data Registry (BCPDR).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• None

Primary outcomes:
measure: Maternal hospital readmission
timeFrame: Up to six weeks post-delivery discharge
measure: Severe maternal morbidity (SMM) event
timeFrame: Up to six weeks post-delivery discharge
Secondary outcomes:
measure: SMM type
timeFrame: Up to six weeks postpartum
measure: Rate of hospital readmission and SMM events
timeFrame: Up to six weeks postpartum
measure: Timing of hospital readmission and SMM events
timeFrame: Up to six weeks postpartum
measure: Maternal characteristics
timeFrame: Up to six weeks postpartum
Other outcomes:
Locations:
Study officials:
References:
citation: Geller SE, Koch AR, Garland CE, MacDonald EJ, Storey F, Lawton B. A global view of severe maternal morbidity: moving beyond maternal mortality. Reprod Health. 2018 Jun 22;15(Suppl 1):98. doi: 10.1186/s12978-018-0527-2.
citation: Dzakpasu S, Deb-Rinker P, Arbour L, Darling EK, Kramer MS, Liu S, Luo W, Murphy PA, Nelson C, Ray JG, Scott H, VandenHof M, Joseph KS. Severe maternal morbidity surveillance: Monitoring pregnant women at high risk for prolonged hospitalisation and death. Paediatr Perinat Epidemiol. 2020 Jul;34(4):427-439. doi: 10.1111/ppe.12574. Epub 2019 Aug 12.