NCT04121234

Brief Summary

Sierra Leone faces the highest maternal mortality ratio in the world. Despite this extreme burden, the potential roles of obstetric critical care and high dependency units (HDUs) in this and other resource-limited settings remain scarcely explored. This study investigated epidemiology, clinical outcomes and risk factors for mortality in critically-ill parturients admitted to an obstetric HDU in a high volume, urban resource-limited maternity hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
523

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

October 7, 2019

Last Update Submit

October 8, 2019

Conditions

Maternal Death

Keywords

High dependency unit; critical care; obstetric critical care; maternal mortality.

Outcome Measures

Primary Outcomes (1)

  • Morality in HDU

    The primary endpoint was the association between modifiable and non-modifiable factors and mortality during HDU stay. HDU death was defined as death during HDU stay, i.e. from referral to HDU to discharge from HDU.

    one year

Secondary Outcomes (6)

  • Hospital mortality

    One year

  • Lenght of stay

    One year

  • OEWS at the admission

    one year

  • reasons of admission

    One Year

  • Time of admission

    One year

  • +1 more secondary outcomes

Interventions

Exposure: " being admitted to HDU with a red code to OEWS"OTHER

High Dependency Unit, a set of predefined variables was assessed at hospital admission, HDU admission and at discharge from HDU with the aim to investigate epidemiology, clinical outcomes and risk factors for mortality in critically-ill parturients admitted to an obstetric HDU in a high volume, urban resource-limited maternity hospital

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women admitted at HDU of the PCMH from the 2nd October 2017 to the 2nd October 2018.

You may qualify if:

  • All women admitted at HDU of the PCMH from the 2nd October 2017 to the 2nd October 2018.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Christian Maternity Hospital

Freetown, Sierra Leone

Location

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 9, 2019

Study Start

May 1, 2018

Primary Completion

June 30, 2019

Study Completion

September 30, 2019

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

SI(1)