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Draft Research Plan

Draft Research Plan for Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Preventive Medication

This opportunity for public comment expired on July 17, 2019 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. 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 Review will form the basis of the USPSTF Recommendation Statement on this topic.

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.

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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how aspirin use my reduce adverse maternal, perinatal, and/or child health outcomes when taken by pregnant persons at  increased risk of preeclampsia (KQ1). Additionally, the figure depicts that aspirin use may prevent preeclampsia in pregnant persons at increased risk of the condition (KQ2), as well as harms associated with aspirin use to prevent preeclampsia during pregnancy (KQ3).

Draft: Proposed Key Questions to be Systematically Reviewed

  1. Does aspirin reduce adverse maternal, perinatal, child, or combined health outcomes in pregnant persons at increased risk of preeclampsia?
    1. Does the effectiveness of aspirin for reducing adverse health outcomes vary by subpopulations defined by personal characteristics or preeclampsia risk factors?
  2. Does aspirin prevent preeclampsia in pregnant persons at increased risk for preeclampsia?
    1. Does the effectiveness of aspirin for reducing preeclampsia vary by subpopulations defined by personal characteristics or preeclampsia risk factors?
  3. What are the harms of aspirin use to prevent preeclampsia during pregnancy?
    1. Do the harms of aspirin use to prevent preeclampsia vary by subpopulations defined by personal characteristics or preeclampsia risk factors?

Draft: Proposed Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. Are there new evidence-based approaches for identifying patients at risk for preeclampsia?
  2. How might recent changes to the diagnostic criteria for preeclampsia and for adult hypertension affect the interpretation or applicability of existing evidence?

Draft: Proposed Research Approach

The Proposed 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).

Category Included Excluded
Populations KQs 1, 2 (Efficacy): Pregnant persons at increased risk for preeclampsia based on:
  • Personal characteristics
  • Medical history
  • Diagnostic measurements or assays (e.g., uterine artery Doppler, biomarkers)
  • Risk prediction model
KQ 3 (Harms): Pregnant persons, fetuses, infants, and children
Nonhuman populations; nonpregnant persons; studies that only/exclusively include persons seeking fertility treatment; and other selected nongeneralizable populations
Disease/condition Primary prevention of preeclampsia Trials of aspirin aimed at preventing other complications of pregnancy (e.g., stillbirth)
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)
Outcomes Maternal outcomes:
  • Preeclampsia
  • Hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome
  • Eclampsia, puerperal cerebrovascular disorder, cerebrovascular hemorrhage, edema, or embolus
  • Renal or hepatic injury/failure
  • Pulmonary edema, adult respiratory distress syndrome
  • Disseminated intravascular coagulation
  • Mental health diagnoses or symptoms
  • Maternal mortality
  • Measures of well-being or quality of life

Potential treatment harms:

  • Abruptio placentae
  • Postpartum hemorrhage
  • Gastrointestinal complications (e.g., bleeding ulcer)

Fetal/neonatal/child outcomes:

  • Preterm birth (<37 weeks), very preterm birth (<32 weeks), extremely preterm birth (<28 weeks)
  • Mean gestational age
  • Low birth weight
  • Intrauterine growth restriction/small for gestational age (<10th percentile weight for gestational age)
  • Stillbirth or neonatal mortality

Potential treatment harms:

  • Intracranial fetal bleeding
  • Fetal malformations
  • Nonclosure of the ductus arteriosus
  • Chorioamnionitis
  • Child behavioral or developmental problems
  • Length of hospital stay (without indication)
  • Intensive care unit admission
  • Neonatal intensive care unit admission
Study Designs KQs 1, 2 (Efficacy): Randomized, controlled trial

KQ 3 (Harms): Randomized, controlled trial or comparative cohort studies

KQs 1, 2 (Efficacy): Any nonrandomized controlled trial

KQ 3 (Harms): Editorials, narrative review, commentary, postmarketing surveillance, or case reports

Language English Languages other than English
Current as of: June 2019

Internet Citation: Draft Research Plan: Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: Preventive Medication . U.S. Preventive Services Task Force. June 2019.
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/aspirin-use-to-prevent-preeclampsia-and-related-morbidity-and-mortality-preventive-medication1

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