Postpartum Anemia Nos
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALBlood Transfusion
Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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: * Hb \<7g/dL OR * \>7g/dL with any sign or symptom of anemia such as fatigue, dizziness, tachycardia, or hypotension * Agreed to accept blood transfusion * No contraindications to blood transfusion
Exclusion criteria
* hemoglobinopathies * patients with an ejection fraction \<35% * Hb \<5 g/dL * HR \> 130 bpm, BP \< 80/40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Units Transfused | From randomization until discharge from admission for delivery, an average of 2-3 days | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum | At 4-9 weeks after randomization | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum. |
| Rate of Depression | 4-9 weeks after randomization | • 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. |
| Length of Stay | From randomization until discharge from admission for delivery, an average of 2-3 days | To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days |
| Maternal Attachment Inventory Scores | 4-9 weeks after randomization | • 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. |
| Infection Rate | From randomization until 4-9 week postpartum visit | Development of any deep or superficial infection |
| Rate of Fatigue | 4-9 weeks after randomization | • 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol | Total |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 6 | 29 years STANDARD_DEVIATION 6 | 29 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 32 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin level at randomization | 6.8 g/dL STANDARD_DEVIATION 0.6 | 7.0 g/dL STANDARD_DEVIATION 0.6 | 6.9 g/dL STANDARD_DEVIATION 0.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 24 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Female | 33 Participants | 33 Participants | 66 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 1 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
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
Time frame: From randomization until discharge from admission for delivery, an average of 2-3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single-Unit Blood Transfusion Protocol | Total Number of Units Transfused | 1.2 units of blood | Standard Deviation 0.5 |
| Multiple-Unit Blood Transfusion Protocol | Total Number of Units Transfused | 2.1 units of blood | Standard Deviation 0.4 |
p-value: <0.001t-test, 2 sided
Secondary
Infection Rate
Development of any deep or superficial infection
Time frame: From randomization until 4-9 week postpartum visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Infection Rate | 2 participants |
| Multiple-Unit Blood Transfusion Protocol | Infection Rate | 1 participants |
p-value: 1Chi-squared
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
Time frame: From randomization until discharge from admission for delivery, an average of 2-3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Length of Stay | 3.1 Days |
| Multiple-Unit Blood Transfusion Protocol | Length of Stay | 3.4 Days |
p-value: 0.79Wilcoxon (Mann-Whitney)
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.
Time frame: 4-9 weeks after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Maternal Attachment Inventory Scores | 104 score on a scale |
| Multiple-Unit Blood Transfusion Protocol | Maternal Attachment Inventory Scores | 104 score on a scale |
p-value: 0.55Wilcoxon (Mann-Whitney)
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.
Time frame: At 4-9 weeks after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum | 16 Participants |
| Multiple-Unit Blood Transfusion Protocol | Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum | 15 Participants |
p-value: 0.89Chi-squared
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.
Time frame: 4-9 weeks after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Rate of Depression | 4 score on a scale |
| Multiple-Unit Blood Transfusion Protocol | Rate of Depression | 5.5 score on a scale |
p-value: 0.34Wilcoxon (Mann-Whitney)
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.
Time frame: 4-9 weeks after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single-Unit Blood Transfusion Protocol | Rate of Fatigue | 44 score on a scale |
| Multiple-Unit Blood Transfusion Protocol | Rate of Fatigue | 53 score on a scale |
p-value: 0.13Wilcoxon (Mann-Whitney)