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

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ClinicalTrials.gov Identifier: NCT02986802
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
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

  Show Detailed Description

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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 : August 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes

Group/Cohort
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02986802


Contacts
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Contact: Roxana Odouli, MSPH 5108913749 roxana.odouli@kp.org

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

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02986802     History of Changes
Other Study ID Numbers: CN-16-2669
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
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