An Observational Study of Hepatitis C Virus in Pregnancy (HCV)
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| ClinicalTrials.gov Identifier: NCT01959321 |
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Recruitment Status :
Completed
First Posted : October 10, 2013
Last Update Posted : March 27, 2023
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| Condition or disease |
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| Hepatitis C |
This multi-center observational study examines risk factors for HCV transmission from mother to baby. The study will also assess risk factors associated with Hepatitis C Virus (HCV) infection in pregnant women. Also, the study will describe the outcomes of pregnant women with HCV as well as the outcomes of their infants to 18 months of age.
Approximately 750 HCV antibody positive pregnant women and their infants will be followed from baseline until the infant is 18 months. A randomly selected control cohort of 500 pregnant women who are HCV antibody negative will be followed until delivery.
| Study Type : | Observational |
| Actual Enrollment : | 772 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | An Observational Study of Hepatitis C Virus in Pregnancy |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | June 30, 2021 |
| Actual Study Completion Date : | June 30, 2021 |
- HCV infection of the offspring [ Time Frame: at 2 months and/or 18 months of age ]
The primary outcome is HCV infection of the offspring, where infection is defined by satisfying any one of the following criteria:
- HCV RNA positive (i.e. presence of viral load) by polymerase chain reaction (PCR) test at 2-6 months (2 month visit)
- HCV RNA positive and HCV antibody positive at the 18-24 months (18 month visit)
- HCV RNA positive at 18-24 months with a negative HCV antibody at 18-24 months and negative RNA at 2-6 months. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify.
- HCV antibody positive at 18-24 months with negative HCV RNA at both visits. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify.
- Clinical result that is either HCV RNA positive or HCV antibody positive obtained at 18 months or older with a confirmed clinical diagnosis of HCV, if a central laboratory sample could not be obtained at 18-24 months.
- Gestational age at delivery [ Time Frame: at birth ]
- Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ]
- Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ]
- Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ]
- Preeclampsia [ Time Frame: during pregnancy ]
- Cholestasis [ Time Frame: during pregnancy ]
- Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ]
- HCV antibody status in infant [ Time Frame: at 18 months of age ]positive or negative
- Birth weight of infant [ Time Frame: at birth ]
- Hyperbilirubinemia [ Time Frame: at birth ]Peak total bilirubin of at least 15 mg% or the use of phototherapy
- Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ]
- Small for gestational age [ Time Frame: at birth ]Defined as less than the 5th percentile birth weight for gestational age at birth, assessed specifically by sex and race of the infant based on United States birth certificate data
- Neonatal infections [ Time Frame: at birth ]sepsis and pneumonia
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Singleton pregnancy
- An HCV antibody positive screen (case) measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.0.
- Gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below.
Exclusion Criteria:
- Planned termination of pregnancy
- Known major fetal anomalies or demise
- Intention of the patient or the managing obstetricians for the delivery to be outside a MFMU Network center, unless special provisions are made to insure infant follow-up at two and 18 months of age.
- Participation in this study in a previous pregnancy.
- Unwilling or unable to commit to 18 months of follow-up for HCV positive infants
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): NCT01959321
Show 17 study locations
| Study Director: | Monica Longo, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |
| Principal Investigator: | Rebecca Clifton, PhD | The George Washington University Biostatistics Center | |
| Study Chair: | Mona Prasad, DO, MPH | Ohio State University |
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Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections |