Transfusion; MaternofetalNCT03738995
Retrospective Survey of Obstetric Red Cell Transfusion in a Tertiary Women's Hospital
An observational study of Transfusion; Maternofetal, run by KK Women's and Children's Hospital.
Trial summary
The decision for red cell transfusion is usually made empirically by clinicians. We aim to perform a two-year retrospective audit of obstetric red cell transfusions at a tertairy women's hospital to evaluate the (1) incidence of obstetric red cell transfusion, (2) indications for transfusion and (3) haemoglobin… Read more about this study
- Who is it for?
- Ages 17 to 50 years, women only
- Conditions the study is for
- Transfusion; Maternofetal
- What is being tested?
- Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartum
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- Women only
- Child, Adult
Study population: Parturients who delivered in the period 1 January 2014 to 31December 2015 (as identified in the hospital's delivery database) and who were administered red cell or whole blood transfusion anytime during pregnancy and up to 6 weeks postnatally (identified using hospital blood bank database) would be included in the study.
Who may be able to join
- Any parturient who had delivered a live or still birth in the period 1 January 2014 to 31 December 2015 AND administered red cell or whole blood transfusion anytime during pregnancy and up to 6 weeks postnatally
Who cannot join
- Intrauterine foetal blood transfusions
- Pregnancies that resulted in miscarriages or stillbirth before 24 weeks of gestation
About this study
The decision for red cell transfusion is usually made empirically by clinicians. We aim to perform a two-year retrospective audit of obstetric red cell transfusions at a tertairy women's hospital to evaluate the (1) incidence of obstetric red cell transfusion, (2) indications for transfusion and (3) haemoglobin triggers and targets of transfusion. Obstetric patients who were given red cell or whole blood transfusion during their pregnancy and who delivered a live or still birth between 1 Jan 2014 to 31 Dec 2015 are included in the analysis. Findings of this study would provide insights into transfusion practice and appropriateness of obstetric red cell transfusion at a tertiary obstetric hospital in Singapore.
Read the detailed description
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.
- Conditions
- Transfusion; Maternofetal
- Being tested
- Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartum
- Keywords
- Red cell transfusion, Obstetric transfusion, anaemia in pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartumBiological
Administration of red cell or whole blood transfusion to parturients during pregnancy and up to 6 weeks postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of transfused parturients per 1000 maternities for the period 2014-2015
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
Measured: 2 years
Secondary outcomes (2)
Nature and frequency of indications for obstetric red cell transfusion
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.
Measured: 2 years
Median haemoglobin concentration pre- and post-transfusion
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Aug 2016
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion; MaternofetalStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738995
- Sponsor's protocol ID
- ver2072016
- Status last verified
- Oct 2018
- First submitted
- 2 Nov 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Survey of Obstetric Red Cell Transfusion in a Tertiary Women's Hospital
- ClinicalTrials.gov ID
- NCT03738995
- Acronym / sponsor ID
- ver2072016
- Conditions
- Transfusion; Maternofetal
- Keywords
- Red cell transfusion, Obstetric transfusion, anaemia in pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The decision for red cell transfusion is usually made empirically by clinicians. We aim to perform a two-year retrospective audit of obstetric red cell transfusions at a tertairy women's hospital to evaluate the (1) incidence of obstetric red cell transfusion, (2) indications for transfusion and (3) haemoglobin triggers and targets of transfusion. Obstetric patients who were given red cell or whole blood transfusion during their pregnancy and who delivered a live or still birth between 1 Jan 2014 to 31 Dec 2015 are included in the analysis. Findings of this study would provide insights into transfusion practice and appropriateness of obstetric red cell transfusion at a tertiary obstetric hospital in Singapore.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Parturients who delivered in the period 1 January 2014 to 31December 2015 (as identified in the hospital's delivery database) and who were administered red cell or whole blood transfusion anytime during pregnancy and up to 6 weeks postnatally (identified using hospital blood bank database) would be included in the study.
Key inclusion criteria (1 listed)
- Any parturient who had delivered a live or still birth in the period 1 January 2014 to 31 December 2015 AND administered red cell or whole blood transfusion anytime during pregnancy and up to 6 weeks postnatally
Key exclusion criteria (2 listed)
- Intrauterine foetal blood transfusions
- Pregnancies that resulted in miscarriages or stillbirth before 24 weeks of gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartumAdministration of red cell or whole blood transfusion to parturients during pregnancy and up to 6 weeks postpartum | Biological | – |
Primary outcome
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
2 secondary outcomes
Nature and frequency of indications for obstetric red cell transfusion
Time frame: 2 years
Median haemoglobin concentration pre- and post-transfusion
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion; Maternofetal, run by KK Women's and Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of transfused parturients per 1000 maternities for the period 2014-2015 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.