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CompletedNCT04121234Updated Oct 10, 2019

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

An observational study in Maternal Death, sponsored by Doctors with Africa - CUAMM. Completed at 1 site in Sierra Leone. Open to female participants. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by Doctors with Africa - CUAMM · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
523
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Maternal Death

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Keywords

  • High dependency unit; critical care; obstetric critical care; maternal mortality.
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In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 523 is above the median of 180 across 19 observational studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Doctors with Africa - CUAMM is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
523 participants (actual)
Patient registry
No

Interventions

  • OtherExposure: " 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

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What researchers measure

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.

    Time frame: one year

Secondary outcomes

  1. Hospital mortality

    Hospital mortality was death during the whole hospital stay.

    Time frame: One year

  2. Lenght of stay

    Time between the hdu admission and the hdu discharge, in days.

    Time frame: One year

  3. OEWS at the admission

    coded as: red, yellow, green

    Time frame: one year

  4. reasons of admission

    classified as: haemodynamic instability; sepsis; haemorrhage; acute renal failure; neurological impairment; respiratory distress; severe malaria; coagulopathy; other diagnoses

    Time frame: One Year

  5. Time of admission

    Night/day and Working days/weeknd

    Time frame: One year

  6. 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).

    Time frame: One year

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Study locations

1 site
  • Princess Christian Maternity Hospital
    Freetown, Sierra Leone
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04121234
Lead sponsor
Doctors with Africa - CUAMM
Responsible party
Claudia Marotta (MD, MPH, Doctors with Africa - CUAMM) — Principal investigator
First posted
Oct 9, 2019
Start date
May 1, 2018
Primary completion
Jun 30, 2019
Completion
Sep 30, 2019
Last update
Oct 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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