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There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.
Postpartum hemorrhage (PPH), which accounts for 30% of all direct maternal deaths, is the single most important cause of maternal morbidity and mortality across the globe and is a focus of attention of national organizations such as the Council for Patient Safety in Women's Health in recent years. Yet, there remains a paucity of data on the appropriate management of non-acute postpartum anemia.
It is common practice in obstetrics to offer a transfusion of packed red blood cells (pRBCs) to women with a hemoglobin (Hb) value less than 7 g/dL (hematocrit less than 20%) and to symptomatic women with even higher hemoglobin levels. Although transfusions were historically initiated with 2 units of pRBCs, the most recent recommendation from the American Association of Blood Banks (AABB) for a stable patient is to begin with 1 unit and reassess. However, while surgical data has successfully demonstrated that liberal blood transfusion increases morbidity and mortality in comparison to restricted transfusion, no randomized controlled trials have been performed in obstetrics to demonstrate superiority of a single-unit transfusion protocol.
The investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single-unit versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity at the University of Pennsylvania with the hypothesis that single-unit transfusions can reduce the number of units transfused without increasing maternal morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Unit Blood Transfusion Protocol | Active Comparator | In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment. |
|
| Multiple-Unit Blood Transfusion Protocol | Active Comparator | In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Transfusion | Biological | Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Units Transfused | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused | From randomization until discharge from admission for delivery, an average of 2-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days | From randomization until discharge from admission for delivery, an average of 2-3 days |
| Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum |
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Inclusion Criteria:
Women over 18
Willing and stable to give consent
> 6 hours postpartum from any mode of delivery
Determined by their physician to require blood transfusion either by:
Agreed to accept blood transfusion
No contraindications to blood transfusion
Exclusion Criteria:
Eligibility is determined by delivery of a fetus.
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| Name | Affiliation | Role |
|---|---|---|
| Sindhu K Srinivas, MD MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34932836 | Derived | Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. | |
| 32652065 | Derived | Hamm RF, Perelman S, Wang EY, Levine LD, Srinivas SK. Single-unit vs multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized controlled trial. Am J Obstet Gynecol. 2021 Jan;224(1):84.e1-84.e7. doi: 10.1016/j.ajog.2020.07.007. Epub 2020 Jul 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-Unit Blood Transfusion Protocol | In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment. Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. |
| FG001 | Multiple-Unit Blood Transfusion Protocol | In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment. Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-Unit Blood Transfusion Protocol | In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment. Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Units Transfused | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused | Posted | Mean | Standard Deviation | units of blood | From randomization until discharge from admission for delivery, an average of 2-3 days |
|
Randomization until the time of the postpartum visit which occurred between 4 and 9 weeks after delivery.
The need for additional blood products and prolonged length of stay will not be considered adverse events as they represent possible issues related to the single-unit blood transfusion protocol. Adverse Events will be obtained by review of the subject's electronic medical record.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-Unit Blood Transfusion Protocol | In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment. Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated transfer to the ICU | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rebecca Hamm | University of Pennsylvania | 215-662-6913 | rebecca.feldmanhamm@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2019 | Aug 25, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2018 | Sep 30, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum. |
| At 4-9 weeks after randomization |
| Rate of Depression | • To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Edinburgh Postnatal Depression Scale score at 4-9 weeks postpartum. EPDS scores range from 0-30, with higher scores (particularly above 10) are indicative of depression. | 4-9 weeks after randomization |
| Rate of Fatigue | • To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Multidimensional Fatigue Inventory scores at 4-9 weeks postpartum. This score ranges from 0-140 with higher scores indicating worse fatigue. | 4-9 weeks after randomization |
| Maternal Attachment Inventory Scores | • To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Maternal Attachment Inventory scores at 4-9 weeks postpartum. The possible range of scores is 26-104. Higher scores indicate higher maternal attachment to the infant. | 4-9 weeks after randomization |
| Infection Rate | Development of any deep or superficial infection | From randomization until 4-9 week postpartum visit |
| Multiple-Unit Blood Transfusion Protocol |
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment. Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin level at randomization | Mean | Standard Deviation | g/dL |
|
|
|
|
| Secondary | Length of Stay | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days | Posted | Median | Inter-Quartile Range | Days | From randomization until discharge from admission for delivery, an average of 2-3 days |
|
|
|
|
| Secondary | Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum. | Posted | Count of Participants | Participants | At 4-9 weeks after randomization |
|
|
|
|
| Secondary | Rate of Depression | • To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Edinburgh Postnatal Depression Scale score at 4-9 weeks postpartum. EPDS scores range from 0-30, with higher scores (particularly above 10) are indicative of depression. | Posted | Median | Inter-Quartile Range | score on a scale | 4-9 weeks after randomization |
|
|
|
|
| Secondary | Rate of Fatigue | • To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Multidimensional Fatigue Inventory scores at 4-9 weeks postpartum. This score ranges from 0-140 with higher scores indicating worse fatigue. | Posted | Median | Inter-Quartile Range | score on a scale | 4-9 weeks after randomization |
|
|
|
|
| Secondary | Maternal Attachment Inventory Scores | • To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Maternal Attachment Inventory scores at 4-9 weeks postpartum. The possible range of scores is 26-104. Higher scores indicate higher maternal attachment to the infant. | Posted | Median | Inter-Quartile Range | score on a scale | 4-9 weeks after randomization |
|
|
|
|
| Secondary | Infection Rate | Development of any deep or superficial infection | Posted | Number | participants | From randomization until 4-9 week postpartum visit |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Multiple-Unit Blood Transfusion Protocol | In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment. Blood Transfusion: Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion. | 0 | 33 | 0 | 33 | 1 | 33 |
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