Draft Research Plan

Hypertensive Disorders of Pregnancy: Screening

May 20, 2021

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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Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how different screening programs used to identify hypertensive disorders of pregnancy among asymptomatic pregnant persons may reduce maternal, perinatal, and child morbidity and mortality (KQ1). Additionally, the figure depicts how effective different screening programs used to identify hypertensive disorders of pregnancy among asymptomatic pregnant persons may be (KQ2), as well as harms that may be associated with different screening programs used to identify hypertensive disorders of pregnancy among asymptomatic pregnant persons (KQ3).

  1. How effective are different screening programs used to identify hypertensive disorders of pregnancy for reducing maternal and perinatal morbidity and mortality?
  2. How effective are different screening programs for identifying persons with hypertensive disorders of pregnancy?
  3. What are the harms of different screening programs used to identify hypertensive disorders of pregnancy?

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

  1. How does racism and social inequalities contribute to existing inequities in morbidity and mortality from hypertensive disorders of pregnancy? For example, what accounts for higher mortality from hypertensive disorders of pregnancy among Black compared with White populations in the United States?
  2. Are there effective interventions that could redress existing inequities in morbidity and mortality from hypertensive disorders of pregnancy? 
  3. What is the effectiveness of blood pressure self-monitoring and its potential utility in telehealth prenatal care delivery?
  4. How are risk assessment and risk prediction tools being used in clinical practice to inform screening programs?

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 Review. Criteria are overarching as well as specific to each of the key questions (KQs).

Category Inclusion criteria Exclusion criteria
Populations Studies among pregnant persons without a diagnosis of hypertensive disorders of pregnancy, including pregnant persons with common chronic conditions managed in usual primary/prenatal care (e.g., chronic hypertension, diabetes mellitus) Studies that exclusively include:
  • Inpatients or hospitalized persons
  • Other selected nongeneralizable populations or populations with other preexisting health conditions requiring specialized prenatal care (e.g., HIV, hepatitis, renal disease, organ transplant recipients, sickle cell trait)
Interventions Screening programs used to identify preeclampsia and other hypertensive disorders of pregnancy over the course of pregnancy and in the postpartum period (up to 8 weeks after delivery), including studies comparing screening with different protocols in terms of:
  • Blood pressure measurement, setting (office or home), interval, frequency, or timing
  • Proteinuria assessment setting, interval, or sequence of testing
  • Personalization of screening based on risk assessment
 Secondary evaluations and tests used to confirm diagnosis or assess disease severity

Prognostic evaluation used to inform disease management
Comparisons Usual care screening programs, as defined by the study  
Outcomes KQ1 (maternal and perinatal health outcomes):

Maternal

  • Eclamptic seizure
  • Stroke
  • Cardiomyopathy, myocardial infarction
  • Renal or hepatic injury/failure
  • Pulmonary edema, adult respiratory distress syndrome
  • Venous thromboembolism (deep vein thrombosis/pulmonary embolism)
  • Disseminated intravascular coagulation
  • Longer-term health consequences from complications of pregnancy
  • Maternal mortality

Fetal/infant

  • Preterm birth (<37 weeks): late preterm birth (34–36 weeks), moderate preterm birth, (32–34 weeks), very preterm birth (<32 weeks), extremely preterm birth (<28 weeks)
  • Gestational age at birth
  • Low birth weight (weight <2,500 g)
  • Intrauterine growth restriction/small for gestational age (<10th percentile weight for gestational age)
  • Stillbirth or neonatal mortality
  • Longer-term health consequences from exposure to maternal hypertensive disorders

KQ 2 (hypertensive disorders of pregnancy):

  • Gestational hypertension
  • Preeclampsia, preeclampsia with severe features
  • Hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome
  • Chronic hypertension with superimposed preeclampsia
  • Timing of diagnosis

KQ 3 (harms):

  • Missed diagnosis (e.g., diagnosis timing, severity at time of diagnosis)
  • Overdiagnosis and overtreatment (e.g., increased labor induction, cesarean delivery, induced preterm birth, hypermagnesemia)
  • Mental health diagnoses or symptoms
  • Reduced quality of life
 Nonclinical health outcomes, such as length of hospital stay (without indication), intensive care unit admission, or neonatal intensive care unit admission
Setting Primary care outpatient settings for obstetric care (e.g., obstetrician-gynecologists, family physicians, certified nurse midwives)

Countries categorized as “Very High” or equivalent on the Human Development Index (as defined by the United Nations Development Programme)

 Clinics and study sites treating only high-risk maternity patients
Study Designs Randomized, controlled trials, controlled clinical trials, and nonrandomized studies comparing screening programs (e.g., comparisons over time or between settings, population cohort studies, nested case-control studies) Studies that do not represent the spectrum of disease (e.g., case-control study, editorial, narrative review, commentary, postmarketing surveillance, and case report)
Publication Dates References from the previous USPSTF review, and eligible studies identified through a bridge search  
Study Quality Good and fair quality according to USPSTF design-specific criteria Poor quality according to USPSTF design-specific criteria
Publication language English Non-English language