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Comparative effectiveness of treatment options for genital herpes infection in pregnant women to reduce adverse pregnancy outcomes
Investigator (PI): Li, De-Kun
Performing Organization (PO): (Current): Kaiser Permanente, Division of Research / (510) 891-3400
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2020
Record Source/Award ID: PCORI/CER-1510-32461
Funding: Total Award Amount: $2,799,498
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births in the United States each year. PTD and LBW present a significant burden to families and society, with annual medical costs of more than $26 billion. Identifying changeable risk factors to reduce PTD is considered to be a top research priority. Reproductive tract infections can trigger early onset of labor. Recent research has shown genital herpes infection is associated with increased risks of PTD and LBW. More importantly, treating genital herpes infection, including infection with no symptoms, using currently readily available antiviral medications (e.g., acyclovir) can be effective in removing the risk from genital herpes infection. Thus, early identification and treatment of genital herpes infection in pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant women with genital herpes infection, especially those with no symptoms, choose not to treat due to 1) a lack of demonstrated benefit of the treatment and 2) general hesitance to use medications during pregnancy out of concern for the fetus. Thus, emerging evidence of an increased risk of PTD and LBW associated with genital herpes infection, if untreated, and treatment effectiveness by antiherpes medications has significantly changed current treatment paradigms on genital herpes infection among pregnant women. This evidence also provides new hope that effectively treating genital herpes infection among pregnant women, especially before the third trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic disparities in the risk of PTD and LBW, as there is a high rate of the infection in minority groups. Thus, to further examine the effectiveness of treating genital herpes in pregnant women in order to reduce adverse pregnancy outcomes, we propose to conduct a prospective cohort study with a two-stage design. It would combine the large pregnant women population (n=90,000) in stage I, identified through Kaiser Permanente Northern California electronic medical records, with a stage II sample, to collect detailed information on history and other characteristics of genital herpes infection, compliance with prescribed treatments, and additional factors that might muddle our understanding of this issue. This study will address the following questions: 1) Does treating genital herpes infection in pregnant women reduce the risk of PTD or LBW (treated vs. untreated)? 2) Does the timing of the treatment during pregnancy influence treatment effectiveness? 3) Do other factors influence treatment effectiveness? and 4) Does genital herpes infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared with no genital herpes infection? Answers to these questions will be valuable to pregnant women and clinicians, and will directly address their concerns when making treatment decisions.
MeSH Terms:
  • Acyclovir /*therapeutic use
  • California
  • Cohort Studies
  • Comparative Effectiveness Research
  • Decision Making
  • Electronic Health Records
  • Ethnic Groups
  • Female
  • Herpes Genitalis /*therapy
  • Humans
  • Infant Mortality
  • Infant, Newborn
  • Maternal Exposure
  • Outcome Assessment, Health Care
  • Pregnancy
  • Pregnancy Complications
  • * Pregnancy Outcome
  • Premature Birth /*prevention & control
  • Prospective Studies
  • Risk
Country: United States
State: California
Zip Code: 94612
UI: 20164043
Project Status: Ongoing
Record History: ('2017: Project extended to 2020.',)