Clinical trial NCT04121234: Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Death
Keywords: High dependency unit; critical care; obstetric critical care; maternal mortality.
Lead sponsor: Doctors with Africa - CUAMM
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 523
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women admitted at HDU of the PCMH from the 2nd October 2017 to the 2nd October 2018.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Morality in HDU
timeFrame: one year
Secondary outcomes:
measure: Hospital mortality
timeFrame: One year
measure: Lenght of stay
timeFrame: One year
measure: OEWS at the admission
timeFrame: one year
measure: reasons of admission
timeFrame: One Year
measure: Time of admission
timeFrame: One year
measure: Treatments received
timeFrame: One year
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Princess Christian Maternity Hospital
Study officials:
References: