An interventional study of Blood Transfusion in Postpartum Anemia Nos, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
Determined by their physician to require blood transfusion either by:
Exclusion Criteria:
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.
Biological: Blood Transfusion
In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Biological: Blood Transfusion
Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
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
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
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
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
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
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
Infection Rate
Development of any deep or superficial infection
Time frame: From randomization until 4-9 week postpartum visit
| Milestone | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Started | 33 | 33 |
| Completed | 33 | 33 |
| Not completed | 0 | 0 |
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused
| units of blood | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Total Number of Units Transfused | 1.2 ± 0.5 | 2.1 ± 0.4 |
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days
| Days | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Length of Stay | 3.1 (2.5 to 3.8) | 3.4 (2.4 to 4.1) |
To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum.
| Participants | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum | 16 | 15 |
• 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.
| score on a scale | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Rate of Depression | 4 (1 to 11) | 5.5 (2 to 8) |
• 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.
| score on a scale | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Rate of Fatigue | 44 (34 to 55) | 53 (38 to 70) |
• 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.
| score on a scale | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Maternal Attachment Inventory Scores | 104 (102 to 104) | 104 (102 to 104) |
Development of any deep or superficial infection
| participants | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Infection Rate | 2 | 1 |
Collected over Randomization until the time of the postpartum visit which occurred between 4 and 9 weeks after delivery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-Unit Blood Transfusion Protocol | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Multiple-Unit Blood Transfusion Protocol | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) |
| Event | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol |
|---|---|---|
| Unrelated transfer to the ICUPregnancy, puerperium and perinatal conditions | 0/33 | 1/33 |
| Age, Continuous(years) | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol | Total |
|---|---|---|---|
| Mean | 29 ± 6 | 29 ± 6 | 29 ± 6 |
| Sex: Female, Male(Participants) | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol | Total |
|---|---|---|---|
| Female | 33 | 33 | 66 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 32 | 32 | 64 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 26 | 24 | 50 |
| White | 4 | 7 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Hemoglobin level at randomization(g/dL) | Single-Unit Blood Transfusion Protocol | Multiple-Unit Blood Transfusion Protocol | Total |
|---|---|---|---|
| Mean | 6.8 ± 0.6 | 7.0 ± 0.6 | 6.9 ± 0.6 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pennsylvania