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Trial record 71 of 126 for:    HSV-2

Comparative Effectiveness of Treatment Options for Genital Herpes Infection to Reduce Adverse Pregnancy Outcomes (PCORIHSV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02986802
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : September 26, 2019
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births with annual medical costs of more than $26 billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is considered a top research priority. Recent research has shown genital herpes infection (HSV) is associated with increased risks of PTD and LBW. More importantly, treating this infection, including infection with no symptoms, using readily available antiviral medications can be effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a lack of demonstrated benefit of treatment and (b) general hesitance to use medications during pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by anti-herpes medications has significantly changed current treatment paradigms among pregnant women. This evidence also provides new hope that effectively treating HSV infection among pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic disparities in these risks due to high rates of the infection in minority groups. Thus, to further examine the effectiveness of treating HSV in pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a prospective cohort study with a two-stage design combining the large pregnant women population (N=90,000) in Stage I identified through Kaiser Permanente Northern California (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed information on additional factors that might muddle our understanding of this issue. This study will address the following: (1) Does treating HSV infection in pregnant women reduce the risk of PTD or LBW? (2) Does timing of the treatment during pregnancy influence treatment effectiveness? (3) Do other factors influence treatment effectiveness? and (4) Does HSV infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared to no infection? Answers to these questions will be valuable to pregnant women and clinicians, and directly address their concerns when making treatment decisions

Condition or disease
HSV-2 Infection PreTerm Birth Pregnancy Complications

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Treatment Options for Genital Herpes Infection in Pregnant Women to Reduce Adverse Pregnancy Outcomes
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Cohort A
Women with genital herpes receiving treatment before the 3rd trimester
Cohort B
Women with genital herpes receiving treatment after the 3rd trimester
Cohort C
Women with untreated genital herpes
Cohort D
Women (controls) with neither genital herpes nor treatment

Primary Outcome Measures :
  1. Preterm Delivery [ Time Frame: birth before 37 completed weeks of gestation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Kaiser Permanente Northern California members

Inclusion Criteria:

  • Kaiser Permanente Northern California members
  • Pregnant women

Exclusion Criteria:

  • Non Kaiser Permanente Northern California members
  • Non pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02986802

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Contact: Roxana Odouli, MSPH 5108913749

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United States, California
Division of Research Recruiting
Oakland, California, United States, 94612
Contact: Roxana Odouli    510-891-3749   
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
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Principal Investigator: De-Kun Li, MD Kaiser Permanente

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Responsible Party: Kaiser Permanente Identifier: NCT02986802     History of Changes
Other Study ID Numbers: CN-16-2669
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Communicable Diseases
Herpes Genitalis
Herpesviridae Infections
Premature Birth
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Herpes Simplex
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female