Postpartum Outcomes in BC

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05461183
• Other study ID #: H21-01696
• Status: Active, not recruiting
• Start date: April 1, 2008
• Est. completion date: January 2023

Study information

• Verified date: July 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15000
• Est. completion date: January 2023
• Est. primary completion date: March 31, 2021
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Delivered in BC from April 1, 2008 to March 31, 2021

• Consented to data collected by the BCPDR

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Morbidity;Perinatal
• Pregnancy Complications
• Pregnancy Related

Intervention

Other:
• Retrospective database analysis
This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Women's Health Research Institute of British Columbia

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal hospital readmission	Cumulative incidence of women who get readmitted into the hospital after being discharged post-delivery	Up to six weeks post-delivery discharge
Primary	Severe maternal morbidity (SMM) event	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.	Up to six weeks post-delivery discharge
Secondary	SMM type	Type of SMM event experienced	Up to six weeks postpartum
Secondary	Rate of hospital readmission and SMM events	Frequency of women who get readmitted to the hospital after discharge and/or experienced at least one SMM event	Up to six weeks postpartum
Secondary	Timing of hospital readmission and SMM events	Specific time frames for women who get readmitted to the hospital after discharge and/or experienced at least one SMM event	Up to six weeks postpartum
Secondary	Maternal characteristics	Characteristics associated with hospital readmission and SMM events after delivery discharge, such as age, race, geographic location, fetal outcome, mode of delivery and pre-existing maternal comorbidities (hypertension, diabetes, and mental health conditions).	Up to six weeks postpartum