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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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.
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Am. J. Obstet. Gynecol. · Jun 2017
ReviewNon-opioid pain management in benign minimally invasive hysterectomy: A systematic review.
Less postoperative pain typically is associated with a minimally invasive hysterectomy compared with a laparotomy approach; however, poor pain control can still be an issue. Multiple guidelines exist for managing postoperative pain, yet most are not specialty-specific and are based on procedures that bear little relevance to a minimally invasive hysterectomy. ⋯ Convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. There is a clear need for more high-quality research that will evaluate each medication type for posthysterectomy pain control.
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Am. J. Obstet. Gynecol. · Jun 2017
Randomized Controlled TrialEfficacy of transcranial direct-current stimulation in women with provoked vestibulodynia.
Provoked vestibulodynia is a highly prevalent condition characterized by acute recurrent pain located at the vaginal entrance in response to pressure application or attempted vaginal penetration. Despite a wide variety of treatments offered to women with provoked vestibulodynia, a high proportion of women are refractory to conventional treatment. Transcranial direct-current stimulation is a noninvasive brain stimulation technique that has been shown effective for improving various chronic pain conditions. Growing evidence suggests that the central nervous system could play a key role in provoked vestibulodynia. Targeting the central nervous system could therefore be a promising treatment for women with provoked vestibulodynia. ⋯ Findings suggest that active transcranial direct-current stimulation is not more effective than sham transcranial direct-current stimulation for reducing pain in women with provoked vestibulodynia. Likewise, no significant effects were found on sexual function, vestibular sensitivity, or psychological distress.