Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting

Maternal Death Clinical Trial

Official title:

Pidemiology, Outcomes and Risk Factors for Mortality in Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121234
• Other study ID #: 070919CUAMM
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Doctors with Africa - CUAMM
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a retrospective observational study in women admitted to the HDU of Princess Christian Maternity Hospital (PCMH), Freetown, Sierra Leone, from 2nd October 2017 to 2nd October 2018. The study received ethical approval and waiver of informed consent from the Sierra Leone Ethics and Scientific Review Committee (18/12/18).

A set of predefined variables was assessed at hospital admission, HDU admission and at discharge from HDU. The primary data source was the HDU patient chart, with data crosschecked with the hospital patient charts and the HDU admission book for quality control purpose. Data of hospital deliveries, admissions and mortality were form the hospital register and the maternal mortality hospital database. Data were retrospectively collected by a study physician (CM) and included: patient demographics; admission date and source; main reason for admission in hospital; main reason for admission to the HDU (classified as: haemodynamic instability; sepsis; haemorrhage; acute renal failure; neurological impairment; respiratory distress; severe malaria; coagulopathy; other diagnoses). These are clinical diagnoses included in the hospital checklist to facilitate communication of referral to HDU and are thus based on the clinical assessment of the attending physician rather than on a strict research definitions.

Vital signs and treatments collected at admission included body temperature, heart rate, respiratory rate, neurological status according to the AVPU scale, systolic and diastolic blood pressure, transcutaneous saturation (SpO2). The ratio between SpO2 and fraction of inspired oxygen (SpO2/FiO2) was also measured. The obstetric modified early warning score (OEWS) was also calculated.

Specific treatments received at any point during HDU stay were extracted from the patient file and included: oxygen supplementation, use of vasopressors, blood transfusions, antibiotic therapy, activation of the magnesium protocol for eclamptic seizures prevention and hypotensive treatment protocol with hydralazine. Point of care laboratory parameters such as capillary lactates levels and haemoglobin were collected when available. Time from PCMH admission to HDU admission was calculated. Length of stay and patient outcomes (classified as death in HDU, discharge to ward, or transfer to other facility) were reported at discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Maternal Death

Intervention

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

Locations

Country	Name	City	State
Sierra Leone	Princess Christian Maternity Hospital	Freetown

Sponsors (1)

Lead Sponsor	Collaborator
Doctors with Africa - CUAMM

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital mortality	Hospital mortality was death during the whole hospital stay.	One year
Secondary	Lenght of stay	Time between the hdu admission and the hdu discharge, in days.	One year
Secondary	OEWS at the admission	coded as: red, yellow, green	one year
Secondary	reasons of admission	classified as: haemodynamic instability; sepsis; haemorrhage; acute renal failure; neurological impairment; respiratory distress; severe malaria; coagulopathy; other diagnoses	One Year
Secondary	Time of admission	Night/day and Working days/weeknd	One year
Secondary	Treatments received	oxygen supplementation (yes/no), use of vasopressors (yes/no), blood transfusions (yes/no), antibiotic therapy (yes/no), activation of the magnesium protocol for eclamptic seizures prevention (yes/no) and hypotensive treatment protocol with hydralazine during the stay (yes/no).	One year