The purpose of this study is to assess the acceptability and feasibility of the use of MyHealthyPregnancy (MHP) 3.0 in clinical practice over a 1 year period of time. The investigators will pilot MHP 3.0 (Spanish and English language options) at practice sites at the Obstetrix Medical Group of Houston, Texas and the UPMC (University of Pittsburgh Medical Center) Healthcare System. Patient and care team feedback will be assessed throughout this study. Patients at Obstetrix Medical Group of Houston will be assessed using 4 short acceptability and feasibility surveys administered by the Naima Health team using a link for an online survey during the study term: at baseline, week 14-18, week 24-28, and week 34-36. A subset of participants at UPMC will also be asked to complete user surveys.

开始日期2022-06-20

申办/合作机构

Naima Health LLC初创企业

[+2]

NCT01996345 / TerminatedN/A

Vaginal Pessary Versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women With Placenta Previa

The purpose of this study is to perform a large multi-center randomized trial comparing the role of vaginal pessary versus expectant management in women with placenta previa between 22w0d and 32w0d of gestation in prolonging gestation until ≥36 weeks. Secondary outcomes will assess duration of antepartum admission, total blood loss, gestational age at delivery, type of cesarean delivery, and a composite neonatal outcome. The hypothesis is that the use of a vaginal pessary in patients presenting with placenta previa between 22-32 weeks will decrease delivery prior to 36 weeks as compared to expectantly managing these patients.

开始日期2016-10-01

申办/合作机构

Pediatrix Medical Group, Inc.

[+1]

NCT02317965 / Unknown statusN/A

A Prospective Clinical Study to Evaluate a Novel Non-invasive Prenatal Screening Method for Characterizing Fetal Whole Chromosome Aberrations and Other Major Defects and Deletions Found in the Maternal Blood.

The purpose of this study is to detect whole chromosome abnormalities in maternal blood.

开始日期2015-03-01

申办/合作机构

Obstetrix Medical Group, Inc.

100 项与 Obstetrix Medical Group, Inc. 相关的临床结果

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0 项与 Obstetrix Medical Group, Inc. 相关的专利（医药）

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项与 Obstetrix Medical Group, Inc. 相关的文献（医药）

2022-01-01·American Journal of Perinatology Reports

Complete Molar Pregnancies with a Coexisting Fetus: Pregnancy Outcomes and Review of Literature

作者: Holliman, Kerry ; Gill, Lisa ; Pilliod, Rachel ; Debbink, Michelle ; Kachikis, Alisa ; Strickland, Kristine ; Day, Lori ; Heuser, Cara ; Mehlhaff, Krista ; Iyer, Chitra ; Irani, Roxanna A. ; Han, Christina S. ; Tureson, Justin ; Shank, Jessica

Objective The objective of the study was to review the obstetric outcomes of complete hydatidiform molar pregnancies with a coexisting fetus (CHMCF), a rare clinical entity that is not well described. Materials and Methods We performed a retrospective case series with pathology-confirmed HMCF. The cases were collected via solicitation through a private maternal-fetal medicine physician group on social media. Each contributing institution from across the United States (n = 9) obtained written informed consent from the patients directly, obtained institutional data transfer agreements as required, and transmitted the data using a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant modality. Data collected included maternal, fetal/genetic, placental, and delivery characteristics. For descriptive analysis, continuous variables were reported as median with standard deviation and range. Results Nine institutions contributed to the 14 cases collected. Nine (64%) cases of CHMCF were a product of assisted reproductive technology and one case was trizygotic. The median gestational age at diagnosis was 12 weeks and 2 days (9 weeks–19 weeks and 4 days), and over half were diagnosed in the first trimester. The median human chorionic gonadotropin (hCG) at diagnosis was 355,494 mIU/mL (49,770–700,486 mIU/mL). Placental mass size universally enlarged over the surveillance period. When invasive testing was performed, insufficient sample or no growth was noted in 40% of the sampled cases. Antenatal complications occurred in all delivered patients, with postpartum hemorrhage (71%) and hypertensive disorders of pregnancy (29%) being the most frequent outcomes. Delivery outcomes were variable. Four patients developed gestational trophoblastic neoplasia. Conclusion This series is the largest report of obstetric outcomes for CHMCF to date and highlights the need to counsel patients about the severe maternal and fetal complications in continuing pregnancies, including progression to gestational trophoblastic neoplastic disease. Key Points

2021-07-01·American Journal of Obstetrics & Gynecology MFM

Impact of adding abdominal circumference to the definition of fetal growth restriction

Article

作者: Webb, Gilbert W ; Castillo, Ramon ; Combs, C Andrew ; Del Rosario, Amber

BACKGROUNDFetal growth restriction has traditionally been defined as fetuses with an estimated fetal weight <10th percentile for gestational age. In 2020, the Society for Maternal-Fetal Medicine recommended that the definition be expanded to include either an estimated fetal weight<10th percentile or a fetal abdominal circumference<10th percentile.OBJECTIVEWe sought to determine the impact of adding the criterion abdominal circumference<10th percentile on the rate of diagnosis of fetal growth restriction vs using the criterion estimated fetal weight<10th percentile alone. In addition, we evaluated the definition proposed by Copel and Bahtiyar, estimated fetal weight<10th percentile or abdominal circumference<5th percentile.STUDY DESIGNThis was a retrospective, descriptive study from 3 consultative maternal-fetal medicine practices. Biometry was compiled from ultrasound examinations from January 2019 to July 2020. The inclusion criteria were singleton pregnancy, gestational age of ≥24 weeks, presence of fetal cardiac activity, and presence of 4 standard fetal biometry parameters (biparietal diameter, head circumference, abdominal circumference, and femur length). We tabulated the indications for the examinations and the number of examinations meeting several criteria for the diagnosis of fetal growth restriction: Traditional criterion (estimated fetal weight<10th percentile), Copel-Bahtiyar criteria (estimated fetal weight<10th percentile or abdominal circumference<5th percentile), and Society for Maternal-Fetal Medicine criteria (estimated fetal weight<10th percentile or abdominal circumference<10th percentile).RESULTSDuring the study period, 20,633 ultrasound examinations met the inclusion criteria. In 62% of examinations, there was ≥1 factor for fetal growth restriction, and in 51% of examinations, there was ≥1 factor for large for gestational age. The rate of estimated fetal weight<10th percentile was 9.7%. The rate of abdominal circumference<5th percentile was 5.7%, and the rate of abdominal circumference<10th percentile was 9.2%. The rate of fetal growth restriction was 9.7% using the traditional definition (estimated fetal weight<10th percentile only). The rate of fetal growth restriction was 10.2% using the Copel-Bahtiyar definition (estimated fetal weight<10th percentile or abdominal circumference<5th percentile), significantly higher than using the traditional definition (P<.001). The rate of fetal growth restriction was 11.6% using the Society for Maternal-Fetal Medicine definition (estimated fetal weight<10th percentile or abdominal circumference<10th percentile), significantly higher than using either the traditional or Copel-Bahtiyar definition (P<.001 for both). Among examinations with an abdominal circumference<10th percentile, 79% also had an estimated fetal weight<10th percentile and was considered fetal growth restriction even without considering abdominal circumference.CONCLUSIONAdding the criterion abdominal circumference<5th percentile or abdominal circumference<10th percentile to the definition of fetal growth restriction resulted in a statistically significant increase in the rate of diagnosis of fetal growth restriction. However, the absolute increase in the rate was small and was not expected to place a large burden on practice resources.

2020-08-02·The Journal of Maternal-Fetal & Neonatal Medicine

Evaluation of additive effect of quantitative fetal fibronectin to cervical length for prediction of spontaneous preterm birth among asymptomatic high-risk women

Article

作者: Terenna, Courtney ; Baxter, Jason K. ; Jwala, Sushma ; Das, Anita ; McGregor, Ali ; Tran, Tino L. ; Berghella, Vincenzo

Objective: To determine if quantitative fetal fibronectin (qFFN) in addition to transvaginal ultrasound (TVU) cervical length (CL) measurement between 18^0/7 and 23^6/7 weeks would be predictive of spontaneous preterm birth (sPTB) at <35^0/7 weeks among asymptomatic high-risk women as defined by those with prior sPTB > 20^0/7 weeks.Material and methods: A prospective observational study of asymptomatic women with singleton gestations between 18^0/7 and 23^6/7weeks and one or more prior SPTB was performed. Women at their anatomy scan who opted into universal CL screening were enrolled. At enrollment, a vaginal speculum exam was performed to collect cervico-vaginal fluid from the posterior fornix using fetal fibronectin (FFN) swab. These women were then followed until delivery. Women with multiple gestations, rupture of membranes, vaginal bleeding, intercourse, or vaginal exam within 48 h of enrollment were excluded. Physicians were blinded to the qFFN levels, but the CL measurements were made available. The primary outcome was sPTB < 35^0/7 weeks.Results: Of the 105 asymptomatic women with prior sPTB who were prospectively enrolled, 19 (18.1%) had recurrent sPTB < 37^0/7 weeks. None of the sPTB were iatrogenic. Using receiver-operating characteristic curves, qFFN ≥ 10 ng/mL had the highest sensitivity with subsequent lowest false negative rate, while FFN ≥ 50 ng/mL was identified as being the best balance of sensitivity and false positive rate for predicting sPTB < 35^0/7 weeks. As compared with CL ≤ 25 mm alone, with the use of CL ≤ 25 mm or qFFN ≥ 50 ng/mL as screening criteria for prediction of SPTB < 35^0/7 weeks, sensitivity improved from 18.2 to 63.6%, specificity decreased from 96.8 to 82.1%, positive predictive value (PPV) decreased from 40.0 to 29.2%, negative predictive value (NPV) marginally improved from 91.1 to 95.1%.Conclusion: In women with singleton gestations with prior SPTB, qFFN can be used as an adjunct to triage patients who are found to have a shortened cervix. Sensitivity and NPVs improved with the addition of qFFN to TVU CL screening alone in women with singleton gestations with prior SPTB. However, specificity and PPVs decreased.

项与 Obstetrix Medical Group, Inc. 相关的新闻（医药）

2023-01-05

·PRNewswire

JUNO DIAGNOSTICS™ ANNOUNCES FORMATION OF CLINICAL ADVISORY BOARD TO SUPPORT ITS NON-INVASIVE PRENATAL SCREENING (NIPS) PRODUCT PORTFOLIO

SAN DIEGO, Jan. 5, 2023 /PRNewswire/ -- Juno Diagnostics™ (JunoDx™), a company focused on bringing vital health information to patients by improving access, affordability, and transparency, today announced the formation of its Clinical Advisory Board ("CAB"). The high-profile board is comprised of leading industry experts in women's health, reproductive medicine, and patient-centered prenatal care, which will further the Company's ability to support a broader community before, during, and after their pregnancy journeys. "We enthusiastically welcome this groundbreaking group of leaders to the Juno Diagnostics team," said Dr. Mathias Ehrich, JunoDx™ Chief Medical Officer. "Our company strives to provide prenatal care that is accessible and affordable because we believe that we can and should do more than the current status quo. The Clinical Advisory Board will further this vision with our members' patient-centered approach to healthcare, including successfully utilizing social media to connect to and support pregnant people directly and in real time. Including maternal-fetal medical specialists, our board breaks the mold often seen within traditional prenatal-focused corporate CABs, offering a diverse perspective on the pregnancy experience closely aligned with the JunoDx™ mission." The CAB will provide clinical guidance that advances JunoDx™ products and mission. The Company's lead product, the Juno Hazel™ screen, is a non-invasive prenatal screening (NIPS) test that utilizes the Company's proprietary Sample Collection Kit, thereby offering improved access to high-quality screening results without the high cost, long lead times, and phlebotomy requirements of traditional NIPS. "We are privileged to work with such an outstanding group of women's health leaders on our Clinical Advisory Board," said Dirk van den Boom, Founder and Chief Executive Officer of JunoDx™. "These recognized leaders represent several different OB/GYN disciplines, including Maternal-Fetal Medicine, Reproductive Endocrinology & Infertility, and Women's Health, as well as deep expertise in the latest advancements in prenatal care. We look forward to their contributions as we grow the adoption of Juno Hazel™ and expand our NIPS portfolio with additional products and services." Juno aims to build a platform enhancing access to prenatal screenings and information for all pregnant people. Through Juno Hazel™ NIPS and its accompanying services, including curated educational resources and personalized genetic counseling support, the Company intends to partner with physicians and genetic counselors to facilitate a higher level of prenatal care. The members of the Clinical Advisory Board include: ALLISON K. RODGERS, M.D. Dr. Allison K. Rodgers is double board-certified in Obstetrics and Gynecology and Reproductive Endocrinology and Infertility who has practiced medicine since 2004. She completed her residency at Case Western Reserve-Metrohealth Medical Center Cleveland Clinic, followed by a fellowship at the University of Texas Health Science Center in San Antonio. She is currently the Director of Education at Fertility Centers of Illinois, a US Fertility Practice. She shares fertility education on social media with more than 1.3 million followers between TikTok and Instagram. Dr. Rodgers' personal experiences with secondary infertility and pregnancy loss inform her unique insights into reproductive medicine, contributing to compassionate and individualized patient care. She is published in top medical journals covering endometriosis, tubal factor infertility, in vitro fertilization, and donor sperm. Her special interests include in-vitro fertilization, endometriosis, polycystic ovarian syndrome, unexplained infertility, recurrent pregnancy loss, premature ovarian insufficiency, LGTBQIA+ fertility, reciprocal IVF, and transgender fertility. CHRISTOPHER ROBINSON, M.D. Dr. Christopher Robinson is a founding partner at Charleston Maternal Fetal Medicine. He provides high-risk pregnancy care and serves as Department Chair for Obstetrics and Gynecology at East Cooper Medical Center in Mount Pleasant, South Carolina. He has recently served on the Board of Directors and Annual Program Committee for the Society for Maternal-Fetal Medicine. Dr. Robinson was nominated for the 2019-2020 Editor Award by the American Journal of Obstetrics and Gynecology, the leading journal in the OB/GYN medical specialty. He has completed advanced training in medical bioinformatics and machine learning and is a globally recognized expert in obesity and hypertensive disease in pregnancy. DANIELLE JONES, M.D. Dr. Danielle Jones is a board-certified OB/GYN from Texas currently practicing in Aotearoa/New Zealand, serving as Lead Colposcopist for the Southland region. In addition to her clinical practice, she is known online as @MamaDoctorJones. She is recognized as a leading voice in pregnancy and gynecology education, with over 3 million followers across platforms like YouTube, TikTok, and Facebook. Dr. Jones acts as a digital ambassador for the American College of Obstetricians and Gynecologists (ACOG), serves as a medical advisor to several start-ups in health technology spaces, and is often cited as an expert by major media outlets such as The New York Times, CNN, and BBC World News. She is passionate about patient empowerment and autonomy, including LGBTQIA+ individuals in pregnancy and gynecologic care, and advocating for reproductive rights through education. DEBORAH BELLESHEIM, WHNP Deborah Bellesheim is a Board-Certified Women's Health Nurse Practitioner (WHNP) who has worked with the Obstetrix Medical Group's outpatient office in Denver, Colorado, since 2015. She earned a Bachelor of Science in Nursing degree from the University of Vermont and completed a Master of Science in Nursing degree from the University of Colorado. Nurse Bellesheim has experience working in high-risk labor and delivery units, where she pursued her interests in managing high-risk pregnancies. She has assisted in facilitating two notable studies focused on prenatal cell-free DNA (cfDNA) screening quality improvement practices. Deborah believes that medical and emotional support provided during prenatal and postpartum care is the most rewarding aspect of her career. LISA MASTERSON, M.D. Dr. Lisa Masterson is a board-certified OB/GYN in private practice in Santa Monica, California, specializing in obstetrics, gynecology, infertility, adolescent gynecology, family planning, and weight management. Dr. Masterson is recognized as the Emmy-nominated co-host of the award-winning daytime medical talk show "The Doctors." Dr. Masterson has been embraced as a spokesperson for women's wellness by Fortune 500 companies and has received accolades from notable groups like the Red Cross and the March of Dimes. Dr. Masterson is globally recognized for her charitable work in decreasing maternal mortality in underprivileged areas of Africa, India, and Southeast Asia. About the Juno Hazel™ Screen The Juno Hazel™ screen is paired with the JunoDx Sample Collection Kit that enables immediate generation of blood plasma for subsequent laboratory testing from only a few drops of blood – reducing cost, increasing access, and improving the NIPS experience. The approach eliminates the need for traditional phlebotomy, a significant access hurdle for this type of test in many clinical settings. Juno Hazel™ screens for common chromosomal variations, including trisomy 21, 18, and 13, with the opportunity to report on additional clinical content. The Juno Hazel™ screen was launched in November 2022. About Juno Diagnostics™ Juno Diagnostics™ is a category-defining health company bringing vital prenatal health information to patients by combining accessibility, affordability, and transparency. The Company has developed a proprietary Sample Collection Kit and Device to facilitate capillary blood-based testing. Its lead product, the Juno Hazel™ screen, is a non-invasive prenatal screening (NIPS) test that utilizes the proprietary Sample Collection Kit and improves access to high-quality screening results without the high cost, long lead times, and phlebotomy requirements of traditional NIPS. For more information, visit and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-366-3243 SOURCE JunoDx

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