Trials Sponsors Conditions Drugs Pricing

Conditions

Herpes Simplex Pregnancy

Outcome Measures

Primary Outcomes (1)

The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery

Secondary Outcomes (3)

To determine HSV seroconversion rates in Group 1 versus Group 2
From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
To determine rates of neonatal HSV infection in Groups 1 & 2.
From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery
To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs.
From time of enrollment (pregnant less than 28 weeks at the time of enrollment) to delivery

Study Arms (2)

1

OTHER

HSV-2 antepartum testing

Procedure: Type specific serologic HSV testing

2

OTHER

Subjects will receive safer-sex counseling during pregnancy

Behavioral: Safer-sex counseling

Interventions

Safer-sex counselingBehavioral

Subjects will receive safer-sex counseling during pregnancy

Type specific serologic HSV testingProcedure

Subjects will be testing for HSV by Western Blot

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age14 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

years of age or older
Pregnant less than 28 weeks at time of enrollment

Sponsors & Collaborators

National Institutes of Health (NIH)
NIHcollaborator
University of Washington
Otherlead

Study Sites (1)

Children's & Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3N1, Canada

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Deborah Money, MD
University of British Columbia
PRINCIPAL INVESTIGATOR
Anna Wald, MD, MPH
University of Washington
PRINCIPAL INVESTIGATOR

Enrollment

173 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

January 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

A Study of HSV Testing Among Pregnant Women

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations