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

NCT02986802 | Completed Results

• 1 other identifier: CN-16-2669
• Study Type: observational
• Target: 89,132
• Locations: 1 country
• Sites: 1

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. 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

Conditions

HSV-2 Infection; PreTerm Birth; Pregnancy Complications

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Preterm Delivery

  Participants who gave birth before 37 completed weeks of gestation

  Up to 37 weeks

• Number of Participants With a Low Birthweight Child

  Women having a child born with birthweight \<2500 grams

  Through the end of pregnancy, an average of 40 weeks

Study Arms (4)

Genital herpes treated before third trimester

Women with genital herpes receiving treatment before the 3rd trimester

Genital herpes treated only during third trimester

Women with genital herpes receiving treatment during the 3rd trimester

Genital herpes untreated

Women with untreated genital herpes

Control group

Women (controls) with neither genital herpes nor treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Kaiser Permanente Northern California members

You may qualify if:

• Kaiser Permanente Northern California members
• Pregnant women

You may not qualify if:

• Non Kaiser Permanente Northern California members
• Non pregnant women

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Premature Birth; Pregnancy Complications

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: De-Kun Li, MD, PhD
• Organization: Kaiser Permanente Division of Research

De-Kun.Li@kp.org

510.891.3755

Study Officials

• De-Kun Li, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: March 14, 2017
• Primary Completion: October 15, 2019
• Study Completion: February 28, 2021
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)