11 Clinical Trials for Various Conditions
Beyond EV-B, there are clinical observations to implicate other viruses in birth defects, including CHD. Since the Rubella epidemic of 1960s', however, viruses have received little attention and certainly no comprehensive study, especially using next generation sequencing (NGS), has been undertaken in this context. The current pandemic as well as those caused by Zika, influenza, Ebola and Lassa Fever (among many) have shown pregnant women and their baby are at high risk. Therefore, an open-minded approach is warranted when considering the role of maternal viral infections in CHD. Even less is known about maternal immune response, such as antibody production, to these viruses. The investigator's goal is to answer the above gaps in knowledge. The investigators propose to do that using two different approaches; one retrospective (analysis of samples in two existing, large biorepositories) and the other prospective. The investigator's have created a multi-disciplinary team to bring together the needed expertise from individuals who have overlapping and vested interest in this project. The investigator's specific aim is to examine the diversity of the gut virome in non-pregnant and pregnant women with and without diabetes, with special emphasis on known cardiotropic viruses (those with tropism for cardiac tissues). This study is seen by the investigator's as the first step prior to a larger prospective multi-institutional study to specifically assess the linkage between the maternal virome and CHD pathogenesis.
The purpose of this study is to advance the scientific understanding of how a prenatal COVID-19 infection and associated psychological distress influences infant neurodevelopment. This project will aim to shed light on how families and child development are impacted by the current COVID-19 pandemic and will work to better support these families and children as they grow.
This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.
This study will evaluate the effectiveness of CenteringPregnancy Plus, a group prenatal care treatment program with an HIV/sexually transmitted disease prevention component, in reducing health risk behaviors in pregnant teenagers seeking services at Community Health Centers in the New York metropolitan area.
This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.
The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children. The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.
COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.
Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor; to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected laboring women and their infants. Original design: To determine the distribution and elimination of zidovudine (AZT) in the body as well as its safety in the treatment of pregnant women and their unborn children. The information derived from this study is required in order to design a future study that will assess the efficacy of AZT in reducing the transmission rate of HIV-1 from seropositive women to their fetus by treating them during the third trimester of pregnancy. An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns. It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1.
To determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and the newborn infant. No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure.
Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.