Final Research Plan
Iron Deficiency Anemia in Pregnant Women: Screening and Supplementation
July 15, 2013
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report will form the basis of the USPSTF Recommendation Statement on this topic.
This Final Research Plan was available for comment from April 11 until May 8, 2013 at 5:00 p.m., ET.
Routine Iron Supplementation in Pregnant Women
This analytic framework outlines the evidence areas covered in the review, including the population, routine supplementation, and outcomes, on a visual pathway. On the left side of the framework, the population includes all pregnant women. Initially, the framework assesses routine supplementation via an overarching arrow leading to the right side of the framework for the goal of reducing maternal and infant morbidity and mortality and quality of life. Harms of routine supplementation are examined as an offshoot arrow. In the center of the framework is the intended goal for decreased iron deficiency anemia.
Screening for Iron Deficiency Anemia in Pregnant Women
This analytic framework outlines the evidence areas covered in the review, including the population, screening, interventions, and outcomes, on a visual pathway. On the left side of the framework, the population includes pregnant women who are asymptomatic for iron deficiency anemia and screened in settings generalizable to primary care. Initially, the framework assesses screening via an overarching arrow leading to the right side of the framework for the goal of reducing maternal and infant morbidity and mortality and quality of life. Harms of screening are examined as an offshoot arrow. Treatment for pregnant women with iron deficiency anemia is indicated on the framework after screening, and an offshoot arrow assesses any resulting harms. In the center of the framework is the intended goal for decreased iron deficiency anemia.
Routine Iron Supplementation in Pregnant Women
- What are the benefits of routine iron supplementation on maternal and infant intermediate and clinical health outcomes in pregnant women?
- What are the harms of routine iron supplementation in pregnant women?
Screening for Iron Deficiency Anemia in Pregnant Women
- What are the benefits of screening for iron deficiency anemia on maternal and infant morbidity, mortality, and quality of life in asymptomatic pregnant women?
- What are the harms of screening for iron deficiency anemia in pregnant women?
- What are the benefits of treatment for iron deficiency anemia on maternal and infant intermediate and clinical health outcomes in pregnant women?
- What are the harms of iron treatment in pregnant women?
Contextual questions are not systematically reviewed and are not shown in the Analytic Framework.
- How well does risk assessment identify pregnant women who are at increased risk for iron deficiency anemia?
- What is the yield (number of new diagnoses) of repeat (periodic) screening in asymptomatic pregnant women? At what timing intervals?
The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Report. Criteria are overarching as well as specific to each of the key questions (KQs).
| Routine Iron Supplementation in Pregnant Women | ||
| Populations | Pregnant adolescents and women and their infants | Severely malnourished populations that are not representative of those in the United States |
| Interventions | Oral iron supplementation, iron-fortified foods | Injectable forms of iron |
| Comparators | No supplementation | |
| Outcomes | KQ 1: Maternal outcomes: Caesarian section rates, preterm delivery, postpartum depression; incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels Infant outcomes: Low birth weight, preterm delivery, perinatal mortality, hematologic indices and ferritin levels KQ 2: More serious harms; discontinuations; accidental overdose |
KQ 2: Gastrointestinal outcomes |
| Settings | Primary care relevant | |
| Timing | KQ 1: Long-term KQ 2: Short- or long-term |
|
| Study Designs | KQ 1: Randomized, controlled trials; controlled cohort studies and other controlled observational studies KQ 2: Studies from KQ 1 and large uncontrolled observational studies |
KQ 1: Uncontrolled studies |
| Screening for Iron Deficiency Anemia in Pregnant Women | ||
| Populations | Pregnant adolescents and women and their infants who are asymptomatic for iron deficiency anemia | Severely malnourished populations that are not representative of those in the United States; those who are symptomatic for iron deficiency anemia |
| Interventions | KQs 1, 2: Screening for iron deficiency anemia KQs 3, 4: Oral iron supplementation, iron-fortified foods |
Injectable forms of iron |
| Comparators | KQs 1, 2: No screening for iron deficiency anemia KQs 3, 4: No treatment |
|
| Outcomes | KQs 1, 3: Maternal outcomes: Caesarian section rates, preterm delivery, postpartum depression Infant outcomes: Low birth weight, preterm delivery, perinatal mortality, hematologic indices and ferritin levels KQ 2: Overdiagnosis, anxiety, labeling. KQ 3: Maternal outcomes: Incidence of iron deficiency anemia; incidence of iron deficiency; hematologic indices and ferritin levels KQ 4: More serious harms; discontinuations and overtreatment |
KQ 4: Gastrointestinal outcomes |
| Settings | Primary care relevant | |
| Timing | KQs 1, 3: Long-term KQs 2, 4: Short- or long-term |
|
| Study Designs | KQs 1, 3: Randomized, controlled trials; controlled cohort studies and other controlled observational studies KQs 2, 4: Studies included from other KQs and large uncontrolled observational studies |
KQ 1, 3: Uncontrolled studies |
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from April 11 to May 8, 2013. A few comments requested clarification on the inclusion and exclusion criteria, analytic frameworks, and key questions related to populations, interventions, and outcomes. The Research Plan was revised in response to these comments. Some comments requested that the USPSTF consider assessing iron status and serum transferrin receptor concentration as additional outcomes. Iron status was added as an intermediate outcome in the analytic framework on routine iron supplementation in pregnant women; the other suggested outcome is not routinely used as a screening test in the United States and is therefore not in the scope of this review.