Retrospective Survey of Obstetric Red Cell Transfusion in a Tertiary Women's Hospital
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|ClinicalTrials.gov Identifier: NCT03738995|
Recruitment Status : Completed
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
|Condition or disease||Intervention/treatment|
|Transfusion; Maternofetal||Biological: Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartum|
Studies suggest an inter-hospital variation in transfusion rates, despite the availability of transfusion guidelines. As part of an initiative to implement patient blood management at our institution, we conducted this retrospective cohort study with the aims of defining the incidence of red cell transfusion among our multiethnic obstetric population and evaluating transfusion practice, with regard to indications and appropriateness.
Ethics approval has been obtained from the institutional review board. Patients who fulfil study criteria would be identified from the hospital's delivery and blood bank registries. Further information would be extracted from the medical records and blood bank database. The delivery registry would also be accessed to obtain the total number of parturients who delivered for the study period.
The following data would be collected and a pro-forma completed:
- Demographic data: age, body mass index, gravidity, parity
- Obstetric data: gestation age at pregnancy booking, occurrence of obstetric conditions associated with bleeding, mode of delivery, estimated blood loss at delivery and antenatal prescription of iron therapy
- Transfusion data: indications for red cell transfusion, number of transfusion events, haemoglobin (Hb) levels at different time points of pregnancy, location of transfusion, adverse events associated with transfusion, activation of massive transfusion protocol
For the purpose of the study, a "transfusion event" is defined as the time interval between prescription of red cells and complete administration to patient. If multiple units were prescribed, all units are considered part of the single event if the time of prescription between consecutive units does not exceed 72 hours.
The incidence of transfusion would be defined as the percentage of patients ('cases') requiring red cell transfusion antenatally and up to 6 weeks postnatally among ALL patients who delivered a live or still birth in the period 2014-2015.
Statistical analysis would be performed using SPSS for windows, version 19 (IBM, Armonk, NY). Data would be presented as mean (+/- SD), median (IQR) or count (%), as appropriate. Missing data would be excluded from the analysis.
|Study Type :||Observational|
|Actual Enrollment :||760 participants|
|Official Title:||Retrospective Survey of Obstetric Red Cell Transfusion in a Tertiary Women's Hospital|
|Actual Study Start Date :||August 1, 2016|
|Actual Primary Completion Date :||March 30, 2018|
|Actual Study Completion Date :||March 30, 2018|
- Biological: Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartum
Administration of red cell or whole blood transfusion to parturients during pregnancy and up to 6 weeks postpartum
- Number of transfused parturients per 1000 maternities for the period 2014-2015 [ Time Frame: 2 years ]Incidence of red cell transfusion is expressed as the number of transfused parturients among all parturients who delivered a live or stillbirth in 2014-2015
- Nature and frequency of indications for obstetric red cell transfusion [ Time Frame: 2 years ]The presence of the following indications for obstetric red cell transfusion among transfused parturients would be recorded and their frequency computed: anaemia in pregnancy, uterine atony, placenta praevia or accreta, genital tract lacerations, retained products of conceptus, placental abruption, coagulopathy, infection, uterine rupture and others.
- Median haemoglobin concentration pre- and post-transfusion [ Time Frame: 2 years ]These values would be compared against Hb criteria for initiation and target for transfusion recommended in transfusion guidelines to determine if transfusion had been appropriately initiated and of appropriate quantity