Morbidity;PerinatalNCT05461183
Postpartum Outcomes in BC
An observational study of Morbidity;Perinatal and Pregnancy Complications, run by University of British Columbia.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Morbidity;Perinatal, Pregnancy Complications, Pregnancy Related
- What is being tested?
- Retrospective database analysis
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2008to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Child, Adult
Study population: Those who delivered between April 1, 2008 to March 31, 2021 using data from the BC Perinatal Data Registry (BCPDR).
Who may be able to join
- Delivered in BC from April 1, 2008 to March 31, 2021
- Consented to data collected by the BCPDR
Who cannot join
- None
About this study
Official title: 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).
Read the 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.
- Being tested
- Retrospective database analysis
- Keywords
- severe maternal morbidity, postpartum period, hospital readmission
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective database analysisOther
This study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Retrospective database analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hospital readmission
Cumulative incidence of women who get readmitted into the hospital after being discharged post-delivery
Measured: 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.
Measured: Up to six weeks post-delivery discharge
Secondary outcomes (4)
SMM type
Type of SMM event experienced
Measured: 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
Measured: 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
Measured: 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).
Measured: Up to six weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Apr 2008
- Primary completion31 Mar 2021
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbidity;PerinatalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Responsible party
- Principal investigator, Marianne Vidler, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461183
- Sponsor's protocol ID
- H21-01696
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29945657Dzakpasu 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.
PubMed 31407359
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cumulative Incidence and Factors Associated With Hospital Re-admission and Severe Maternal Morbidity After Delivery Discharge in British Columbia
- ClinicalTrials.gov ID
- NCT05461183
- Acronym / sponsor ID
- H21-01696
- Keywords
- severe maternal morbidity, postpartum period, hospital readmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- Jan 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Readmission/ SMM post-delivery discharge | – | Other: Retrospective database analysisAll 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 |
| De novo readmission/ SMM post-delivery discharge | – | Other: Retrospective database analysisAll 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 |
| No post-delivery discharge readmission/ SMM at any time (CONTROL) | – | Other: Retrospective database analysisAll women aged 15-49 who did not experience post-delivery discharge readmission and/or SMM at any time |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Those who delivered between April 1, 2008 to March 31, 2021 using data from the BC Perinatal Data Registry (BCPDR).
Key inclusion criteria (2 listed)
- Delivered in BC from April 1, 2008 to March 31, 2021
- Consented to data collected by the BCPDR
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective database analysisThis study will review data provided by the BCPDR from April 1, 2008 to March 31, 2021. | Other | De novo readmission/ SMM post-delivery discharge, No post-delivery discharge readmission/ SMM at any time (CONTROL), Readmission/ SMM post-delivery discharge |
Primary outcome
Maternal hospital readmission
Time frame: Up to six weeks post-delivery discharge
Cumulative incidence of women who get readmitted into the hospital after being discharged post-delivery
Severe maternal morbidity (SMM) event
Time frame: Up to six weeks post-delivery discharge
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.
4 secondary outcomes
SMM type
Time frame: Up to six weeks postpartum
Rate of hospital readmission and SMM events
Time frame: Up to six weeks postpartum
Timing of hospital readmission and SMM events
Time frame: Up to six weeks postpartum
Maternal characteristics
Time frame: Up to six weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 29945657Geller 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.
- Background: PubMed 31407359Dzakpasu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbidity;Perinatal and Pregnancy Complications, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal hospital readmission (time frame: Up to six weeks post-delivery discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.