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Trial record 4 of 8 for:    Recruiting, Not yet recruiting, Available Studies | amniocentesis

Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

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ClinicalTrials.gov Identifier: NCT02351102
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Keren shahar-nissan, Rabin Medical Center

Brief Summary:
The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

Condition or disease Intervention/treatment Phase
Congenital Cytomegalovirus Infection Drug: Valacyclovir Drug: Placebo Phase 2 Phase 3

Detailed Description:

A randomized, double-blind, placebo-controlled study.

Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester

Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy
Study Start Date : November 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Active Comparator: Valacyclovir
Participants will receive Valacyclovir at a dose of 8g/d starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation)
Drug: Valacyclovir
Placebo Comparator: Placebo
Participants will receive placebo pills (same daily amount as the intervention group) starting at time of proof of primary maternal CMV infection and until amniocentesis (minimum 21 weeks gestation)
Drug: Placebo



Primary Outcome Measures :
  1. CMV Polymerase Chain Reaction (PCR) in amniotic fluid [ Time Frame: minimum 21 weeks gestation ]
    amniocentesis will be performed no earlier than 21 weeks gestation, and at least 7 weeks after estimated seroconversion occured. Therefore, the time frame for amniocentesis is estimated between 21 weeks gestation to 28 weeks gestation


Secondary Outcome Measures :
  1. Clinical evidence of symptomatic congenital CMV infection [ Time Frame: within 1 week after delivery ]
    laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester of pregnancy or periconceptionally

Exclusion Criteria:

  • Patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to Acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.

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): NCT02351102


Contacts
Contact: Keren Shahar-Nissan, Dr 972-3-9253775 kerens411@gmail.com
Contact: Jacob Amir, Professor 972-3-9253775 amirj@clalit.org.il

Locations
Israel
Helen Schneider Hospital for Women Recruiting
Petah Tikva, Israel
Contact: Keren Shahar, Dr.         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Keren Shahar-Nissan, Dr Schneider Children's Medical Center, Israel

Publications:
Responsible Party: Keren shahar-nissan, Paediatrics C ward, Schneider Children's Medical Centre of Israel, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02351102     History of Changes
Other Study ID Numbers: 655-14
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Keren shahar-nissan, Rabin Medical Center:
Congenital CMV
Congenital Cytomegalovirus

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents