Final Research Plan
Final Research Plan for Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Preventive Medication
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 will be 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.
The draft Research Plan was available for comment from June 20 until July 23, 2019 at 8:00 p.m., ET.
Key Questions to be Systematically Reviewed
- Does aspirin reduce adverse maternal, perinatal, child, or combined health outcomes in pregnant persons at increased risk of preeclampsia?
- Does the effectiveness of aspirin for reducing adverse health outcomes vary by subpopulations defined by personal characteristics or preeclampsia risk factors?
- Does aspirin prevent preeclampsia in pregnant persons at increased risk for preeclampsia?
- Does the effectiveness of aspirin for reducing preeclampsia vary by subpopulations defined by personal characteristics or preeclampsia risk factors?
- What are the harms of aspirin use to prevent preeclampsia during pregnancy?
- Do the harms of aspirin use to prevent preeclampsia vary by subpopulations defined by personal characteristics or preeclampsia risk factors?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- Are there new evidence-based approaches for identifying patients at risk for preeclampsia in clinical practice?
- How might recent changes to the diagnostic criteria for preeclampsia and for adult hypertension affect the interpretation or applicability of existing evidence?
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).
|Populations||KQs 1, 2 (Efficacy): Pregnant persons at increased risk for preeclampsia based on:
||Nonhuman populations; nonpregnant persons; studies that only/exclusively include persons seeking fertility treatment; and other selected nongeneralizable populations|
|Primary prevention of preeclampsia||Trials of aspirin aimed at preventing other complications of pregnancy (e.g., stillbirth)|
|Setting||Countries categorized as “very high” on the 2017 Human Development Index (as defined by the United Nations Development Programme)||Countries not categorized as “very high” on the 2017 Human Development Index, as there is concern for nutritional deficiencies in developing countries|
|Interventions||Aspirin (≥50 mg)||Nonaspirin antiplatelet medications or aspirin combined with other potentially active interventions|
|Comparisons||Placebo or no treatment||Any active substance or intervention (e.g., nonaspirin medication, dietary supplements, dietary change, bed rest, or weight loss)|
Potential treatment harms:
Potential treatment harms:
|Study Designs||KQs 1, 2 (Efficacy): Randomized, controlled trials; individual participant data meta-analysis of trials
KQ 3 (Harms): Randomized, controlled trials; comparative cohort studies; or individual participant data meta-analysis of trials
|KQs 1, 2 (Efficacy): Nonrandomized controlled trials
KQ 3 (Harms): Editorials, narrative review, commentary, postmarketing surveillance, or case reports
|Study Quality||Good- and fair-quality studies||Poor-quality studies|
|Language||English||Languages other than English|
Response to Public Comment
The draft Research Plan was posted for public comment on the USPSTF website from June 20 to July 23, 2019. The USPSTF made several minor additions and wording changes to improve the clarity and specificity of the inclusion criteria. The USPSTF included additional clinically important categories to define preeclampsia and preterm birth to more fully represent health outcomes that may be reported in the literature.
Internet Citation: Final Research Plan: Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Preventive Medication . U.S. Preventive Services Task Force. September 2019.