American journal of obstetrics and gynecology
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Am. J. Obstet. Gynecol. · Jul 2017
Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety.
The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. ⋯ Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.
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Am. J. Obstet. Gynecol. · Jun 2017
Is cerebroplacental ratio a marker of impaired fetal growth velocity and adverse pregnancy outcome?
The cerebroplacental ratio has been proposed as a marker of failure to reach growth potential near term. Low cerebroplacental ratio, regardless of the fetal size, is independently associated with the need for operative delivery for presumed fetal compromise and with neonatal unit admission at term. ⋯ The cerebroplacental ratio is a marker of impaired fetal growth velocity and adverse pregnancy outcome, even in fetuses whose size is considered appropriate using conventional biometry.
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The current recommendation regarding the management of a term newborn delivered of a mother with an intrapartum fever or a diagnosis of clinical chorioamnionitis is that the neonate should have baseline laboratory work drawn along with blood cultures and be universally treated with antibiotics until culture results return. These guidelines report that the rate of intrapartum fever is about 3%; however, a few large studies suggest that the rate is higher at about 7%. ⋯ The incidence of an intrapartum fever of ≥38°C in pregnancies at ≥36 weeks' gestation is common at 6.8% and this is consistent with the findings of a few other large retrospective studies. The rate of an intrapartum fever occurs in approximately 1 in 15 women in labor. The risk of neonatal sepsis in newborns delivered of mothers with intrapartum fever or a diagnosis of clinical chorioamnionitis is low at 0.24%, a rate that is <1 in 400. The recommendation for universal laboratory work, cultures, and antibiotic treatment pending culture results for this newborn population needs further examination.
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Am. J. Obstet. Gynecol. · Jun 2017
Two-year continuation of intrauterine devices and contraceptive implants in a mixed-payer setting: a retrospective review.
As the popularity of long-acting reversible contraception increases, so does the need for accurate data on method continuation in diverse clinical settings. We determined 2-year continuation rates for the levonorgestrel 52-mg intrauterine device, the copper T380A intrauterine device, and the 68-mg etonogestrel contraceptive implant in an academic healthcare system with mixed-payer reimbursement. ⋯ Three-quarters of women with an intrauterine device or implant continue using it for 2 years. In this cohort, the 2-year continuation rates were 77.8%, 73.1%, and 75.9% for the levonorgestrel 52-mg intrauterine device, copper T380A intrauterine device, and 68-mg etonogestrel implant, respectively.
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Am. J. Obstet. Gynecol. · Jun 2017
17-alpha Hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study.
17-alpha Hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States. ⋯ 17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes.