- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121234
Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting
Pidemiology, Outcomes and Risk Factors for Mortality in Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Freetown, Sierra Leone
- Princess Christian Maternity Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All women admitted at HDU of the PCMH from the 2nd October 2017 to the 2nd October 2018.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morality in HDU
Time Frame: one year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital mortality
Time Frame: One year
|
Hospital mortality was death during the whole hospital stay.
|
One year
|
Lenght of stay
Time Frame: One year
|
Time between the hdu admission and the hdu discharge, in days.
|
One year
|
OEWS at the admission
Time Frame: one year
|
coded as: red, yellow, green
|
one year
|
reasons of admission
Time Frame: One Year
|
classified as: haemodynamic instability; sepsis; haemorrhage; acute renal failure; neurological impairment; respiratory distress; severe malaria; coagulopathy; other diagnoses
|
One Year
|
Time of admission
Time Frame: One year
|
Night/day and Working days/weeknd
|
One year
|
Treatments received
Time Frame: One year
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070919CUAMM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Maternal Death
-
University of OttawaJimma University; Ethiopian Ministry of Health, Jimma ZoneCompletedMaternal Mortality | Maternal Morbidity
-
Harvard School of Public Health (HSPH)Brigham and Women's Hospital; Bill and Melinda Gates Foundation; World Health... and other collaboratorsCompletedMaternal Death | Stillbirth | Maternal Morbidity | Neonatal DeathIndia
-
Massachusetts General HospitalMbarara University of Science and TechnologyUnknownPregnancy Complications | Maternal Death During ChildbirthUganda
-
University of CalgaryCanadian International Development AgencyCompletedChild Mortality | Maternal Mortality (All Cause)Uganda
-
Abdul Latif Jameel Poverty Action LabMacArthur Foundation; Planned Parenthood Federation NigeriaCompletedMaternal MortalityNigeria
-
Society for Applied StudiesWorld Health OrganizationCompletedStill Births | Neonatal Deaths | Maternal DeathsIndia
-
Jimma UniversityRecruitingMaternal Behavior | Maternal DeathEthiopia
-
University of CopenhagenMerck Sharp & Dohme LLCCompletedMaternal Mortality | Perinatal MortalityDenmark
-
Hawassa UniversityUniversidad Pública de NavarraRecruiting
-
University of OxfordRecruitingCause of Mortality | Cause of Neonatal Death | Cause of Child Death | Cause of Maternal Death | Cause of Adult DeathLao People's Democratic Republic, Cambodia, Bangladesh, Myanmar, Thailand
Clinical Trials on Exposure: " being admitted to HDU with a red code to OEWS"
-
Medical Center AlkmaarAalborg University; VU University of Amsterdam; Technical University of Twente; Rudolf Magnus Institute - University of Utrecht and other collaboratorsCompleted
-
Memorial Sloan Kettering Cancer CenterCompletedNon-Hodgkin's Lymphoma | CNS Lymphoma | CNS Brain CancerUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedAcute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Switzerland