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Completed

NCT Number: NCT03419780

SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood transfusion

Biological

Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.

Primary outcomes

  1. Total Number of Units Transfused

    Time frame: 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 outcomes

  1. Length of Stay

    Time frame: 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

  2. Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum

    Time frame: 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.

  3. Rate of Depression

    Time frame: 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.
  4. Rate of Fatigue

    Time frame: 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.
  5. Maternal Attachment Inventory Scores

    Time frame: 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.
  6. Infection Rate

    Time frame: From randomization until 4-9 week postpartum visit

    Development of any deep or superficial infection

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial

Acronym: SMaRTBlood

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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