Postpartum Outcomes in BC

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Complications; Pregnancy Related; Morbidity;Perinatal
• Intervention / Treatment: Other: Retrospective database analysis

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.

• Study Type: Observational
• Enrollment (Anticipated): 15000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Readmission/ SMM post-delivery discharge; All women aged 15-49 who were readmitted up to six weeks post-delivery discharge and/or experienced at least one SMM event up to six weeks post-delivery	Other: Retrospective database analysis; This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.
De novo readmission/ SMM post-delivery discharge; All women aged 15-49 who were readmitted up to six weeks post-delivery discharge and/or experienced at least one SMM event post-delivery, excluding those who experienced a SMM in the two months before delivery or during delivery hospitalization	Other: Retrospective database analysis; This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.
No post-delivery discharge readmission/ SMM at any time (CONTROL); All women aged 15-49 who did not experience post-delivery discharge readmission and/or SMM at any time	Other: Retrospective database analysis; This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SMM type	Type of SMM event experienced	Up to six weeks postpartum
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
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
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Women's Health Research Institute of British Columbia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): March 31, 2021
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: hospital readmission; postpartum period; severe maternal morbidity
• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: H21-01696

Drug and device information, study documents

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