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Ben Schwartz is Associate Editor, Contemporary OB/GYN.
One study looks at how successful the 9vHPV vaccine is in preventing HPV-related cervical, vaginal, and vulvar diseases. Plus: FDA approves first neonatal MRI. Also, researchers note that obstetric services in rural areas severely lacking.
A study published in The Lancet showed that the human papillomavirus (HPV) vaccine, 9vHPV (Garadisil 9), is highly effective at preventing HPV infection and disease. The vaccine protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; HPV 16 and 18 are estimated to cause 70% of all cervical cancers. The researchers found that the vaccine is also highly effective at reducing the risk of having HPV 31/33/45/52/58-associated cervical cell abnormalities.
The phase 3 study was conducted by researchers from 18 countries and 105 study sites and randomized 14125 women between 16 and 26 years old to receive either 9vHPV (n=7106) or qHPV (Garadasil) (n=7109), an existing HPV vaccine that protects against HPV 16 and 18 as well as genital warts caused by HPV 6 and 11. The primary outcomes of the study were incidence of high-grade cervical disease, vulvar disease, and vaginal disease related to HPV 31, 33, 45, 52, and 58. The primary evaluation of efficacy was a superiority analysis in the per-protocol efficacy population. Supportive efficacy was analyzed in the modified intention-to-treat population and the primary evaluation of immunogenicity was a non-inferiority analysis.
The researchers found that the 9vHPV vaccine reduced the risk of developing HPV 31/33/45/52/58-related cervical, vaginal, and vulvar disease by 97.7% when compared to qHPV. It was noted that both vaccines were similar at preventing HPV 6/11/16/19-associated disease. Participants in the study were followed medically for 6 years after vaccination. No clinically meaningful differences in serious adverse events were noted in the study groups.
9vHPV became available in 2015 to protect both females and males against HPV-associated cancers and genital warts. The published study was funded by Merck & Co, Inc.
FDA approves first neonatal MRI
The first magnetic resonance imaging (MRI) device designed specifically for use in neonatal intensive care units (NICUs) has received approval from the US Food and Drug Administration (FDA). The Embrace Neonatal MRI System is specifically for imaging the heads of neonates.
Developed by Aspect Imaging Ltd., the device can be used on neonates with a head circumference ≤38 cm and weight from 1 to 4.5 kg. Its use is contraindicated in larger infants or those who have metallic or electronically active implants. A temperature-controlled incubator is part of the system, which minimizes movement of a neonate. If urgent access is required during an MRI, a neonate can be removed from the system in less than 30 seconds.
Efficacy of the device was demonstrated primarily through non-clinical testing with images of phantoms simulating an infant brain that were of sufficient quality for diagnostic use by an independent board-certified radiologist. Performance testing, including a review of electrical and mechanical safety measures, was done to demonstrate the system’s safety.
Study: Obstetric services in rural areas severely lacking
According to research published online in Health Affairs, nearly half (45%) of rural counties in the United States lacked hospitals offering obstetric services from 2004 to 2014, and of those that did, 9% lost all of their obstetric services during that period.
Looking at 1249 hospitals in 1086 rural counties, the study found that lower-income counties, counties with a higher percentage of African-American women, and states that had lower income thresholds for Medicaid eligibility for pregnant women were most likely to have their obstetric services reduced. The authors explain that in 2017, the range for Medicaid eligibility was from 138% to 380% of the federal poverty level, meaning that rural families with similar incomes and health may receive vastly different coverage depending on which state they live in.
The authors note that 28 million American women of child-bearing age live in rural areas, with approximately half a million births in rural hospitals. Many of these women are already at higher risk for complications during pregnancy, so reducing the availability of obstetric services further harms this population. According to the study, odds of postpartum hemorrhage were 31% higher with deliveries in rural hospitals than in urban teaching hospitals. Likewise, infant and maternal mortality rates were much higher for rural mothers than for mothers in urban areas. Rural areas averaged 29.4 maternal deaths per 100,000 live births in rural areas during 2015 compared to 18.2 maternal deaths per 100,000 births in urban areas. Infant mortality in rural areas was 6.7 deaths per 1000 live births compared with 5.6 deaths per 1000 live births in urban areas.
Another potential cause is the amount of extra travel women who live in rural areas may have to do to visit an obstetrician. According to the study, more than half of rural women must travel more than 30 minutes to reach an obstetrician, compared to 7% of urban mothers who have to travel that distance. The authors suggest that advances in telemedicine may be one solution to lessening the travel and distance between obstetricians and would allow high-risk patients to connect with their specialist immediately.