Postpartum Outcomes in BC

NCT05461183 | Unknown

• 1 other identifier: H21-01696
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Morbidity;Perinatal; Pregnancy Complications; Pregnancy Related

Keywords

severe maternal morbidity; postpartum period; hospital readmission

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• SMM type

  Up to six weeks postpartum

• Rate of hospital readmission and SMM events

  Up to six weeks postpartum

• Timing of hospital readmission and SMM events

  Up to six weeks postpartum

• Maternal characteristics

  Up to six weeks postpartum

Study Arms (3)

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

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

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

Interventions

Retrospective database analysis 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; No post-delivery discharge readmission/ SMM at any time (CONTROL); Readmission/ SMM post-delivery discharge

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of British Columbia: lead
• Women's Health Research Institute of British Columbia: collaborator

Related Publications (2)

• 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.

  PMID: 29945657 BACKGROUND

• 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.

  PMID: 31407359 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 18, 2022
• Study Start: April 1, 2008
• Primary Completion: March 31, 2021
• Study Completion: January 1, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07