Postpartum Outcomes in BC

NCT ID: NCT05461183

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-01
• Study Completion Date: 2023-01-31

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.

Conditions

Morbidity;Perinatal; Pregnancy Complications; Pregnancy Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Retrospective database analysis

Intervention Type: OTHER

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

Retrospective database analysis

Intervention Type: OTHER

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

Retrospective database analysis

Intervention Type: OTHER

This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.

Interventions

Retrospective database analysis

This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Health Research Institute of British Columbia

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Marianne Vidler

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 29945657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31407359 (View on PubMed)

Other Identifiers

H21-01696

Identifier Type: -

Identifier Source: org_study_id