Jane R. Montealegre, PhD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the effectiveness of mailed at-home self-sampling for HPV testing in a safety-net health system setting. The analysis included data from 2115 patients who were randomly assigned to one of the 3 following arms: telephone recall to provider-performed screening (usual care; arm 1); telephone recall + mailed self-sampling kit for HPV testing (arm 2); or telephone recall + mailed self-sampling kit + telephone-based patient navigation (arm 3).

The researchers found that among participants, the median time since last screening test was 9.5 years. Screening participation across arms 1, 2, and 3 was 15.3, 44.0, and 51.4%, respectively. Compared with usual care (arm 1), the relative incidence of screening in arms 2 and 3 was 2.90 and 3.36, respectively. For arm 3 vs arm 2, the relative incidence of screening was 1.16.

“After US Food and Drug Administration approval, self-sampling for high-risk-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations,” the authors write.

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Laura Witt, from St. Joseph Hospital at Ruhr University in Bochum, Germany, and colleagues examined infant development during the first 36 months of life for infants of mothers receiving mAb for multiple sclerosis. A total of 183 mAb breastfed-exposed infants whose mothers had a diagnosis of multiple sclerosis or neuromyelitis optica spectrum disease were compared to 183 unexposed infants (controls). mAb exposure during breastfeeding started on a median of 19 days postpartum.

Breastfeeding participants most often received natalizumab, followed by ocrelizumab, rituximab, and ofatumumab (68.31, 18.58, 6.01, and 5.46%, respectively); while breastfeeding, 2 cases switched from natalizumab to ocrelizumab and one from rituximab to ocrelizumab. The researchers found that annual infant hospitalization, annual systemic antibiotic use, developmental delay, or weight at follow-up visits were not associated with mAb-exposed breastfeeding.

“Our data show infants exposed to these medications through breastfeeding experienced no negative effects on health or development within the first three years of life,” coauthor Kerstin Hellwig, MD, also from St. Joseph Hospital, said in a statement.

The study was partly funded by pharmaceutical companies.

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Viktor H. Ahlqvist, PhD, from the Karolinska Institutet in Stockholm, and colleagues conducted a nationwide cohort study with a sibling control analysis including a population-based sample of 2,480,797 children born in 1995 to 2019 in Sweden to examine the associations of acetaminophen use during pregnancy with children’s risk for autism, ADHD, and intellectual disability.

The researchers found that ever-use versus no use of acetaminophen during pregnancy was associated with a marginally increased risk for autism (hazard ratio, 1.05; 95% CI, 1.02 to 1.08), ADHD (hazard ratio, 1.07; 95% CI, 1.05 to 1.10), and intellectual disability (hazard ratio, 1.05; 95% CI, 1.00 to 1.10) in models without sibling control. Matched full-sibling pairs were also analyzed to address unobserved confounding. There was no evidence that acetaminophen use during pregnancy was associated with autism, ADHD, or intellectual disability in sibling control analyses. No evidence of a dose-response pattern was seen in sibling control analyses.

“This suggests that associations observed in models without sibling control may have been attributable to confounding,” the authors write.

One author disclosed ties to Neobiomics AB; a second author disclosed ties to law firms and AlphaSights.

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HealthDay News — For women with moderate-to-severe nausea and vomiting of pregnancy (NVP), both acupuncture and doxylamine-pyridoxine are efficacious, and the combination may yield a larger benefit than either treatment alone, according to a study published online June 20 in the Annals of Internal Medicine.

Xiao-Ke Wu, MD, PhD, from the Heilongjiang University of Chinese Medicine in Harbin, and colleagues examined the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in 352 women in early pregnancy with moderate-to-severe NVP. Participants received 30 minutes of daily active or sham acupuncture and 14 days of doxylamine-pyridoxine or placebo.

The researchers observed no significant interaction between the interventions. A larger reduction in the Pregnancy-Unique Quantification of Emesis score was seen over the treatment course for acupuncture, doxylamine-pyridoxine, and the combination of both compared with their respective control groups (mean differences, −0.7, −1.0, and −1.6, respectively). The risk for births with children who were small for gestational age was higher with doxylamine-pyridoxine vs placebo.

“The combination of both treatments showed numerically larger and potentially more clinically meaningful benefit than either treatment alone,” the authors write. “This finding is especially significant because there is a pressing need to establish a pregnancy-safe treatment regimen and an integrative guideline for managing severe NVP.”

One author disclosed ties to industry.

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Jamie Kitt, DPhil, from the University of Oxford in the United Kingdom, and colleagues assessed whether remote self-monitoring and physician-guided titration of antihypertensive medications using a Bluetooth-enabled app provides better long-term blood pressure control than usual outpatient care during the first nine months postpartum. The analysis included 200 participants randomly assigned following a hypertensive pregnancy.

The researchers found that the 24-hour mean diastolic blood pressure, measured at 249 days postpartum, was 5.8 mm Hg lower in the intervention group (71.2 vs 76.6 mm Hg) than in the control group (between-group difference, −5.80 mm Hg). Similar results were seen for 24-hour mean systolic blood pressure (114.0 vs 120.3 mm Hg; between-group difference, −6.51 mm Hg).

“An intervention that lowers blood pressure by 5 mm Hg would be expected to delay progression to hypertension by many years and, over a lifetime, reduce risk of cardiovascular or cerebrovascular events,” the authors write.

Two authors disclosed financial ties to Sensyne Health.

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Govenor Kay Ivey, a Republican, signed the bill into law shortly after it was passed by the Senate on Wednesday.

Following the signing, 2 major fertility clinics said they will restart IVF treatments while another clinic said the scope of protections was unclear and it would wait for “legal clarification,” the New York Times reported.

Lawmaker support for the bill was strong, 81 to 12, with 9 abstentions, in the House and 29 to 1 in the Senate, the Times reported.

Why was the legislation passed so quickly?

The state Supreme Court ruling raised fears about civil and criminal liability among infertility doctors and clinics.

Shortly after the ruling was issued, at least three major clinics stopped IVF treatments and an embryo shipping company paused its business in the state, the Times reported. Meanwhile, IVF patients pleaded with lawmakers and protested to preserve their right to grow their families.

The new law stops short of addressing whether a frozen embryo conceived outside of the womb should be considered a person. Instead, it broadly shields clinics and IVF providers from civil and criminal liability.

“The problem we’re trying to solve right now is to get those families back on a track to be moving forward as they try to have children,” said State Rep. Terri Collins, who sponsored the measure in the House. “Will we need to address that issue? Probably.”

“I don’t want to define life, that’s too important to me, to my faith,” Collins told the Times. “But we do have to decide where we begin protection, and that’s what I think we’ll have to talk about.”

Meanwhile, Infirmary Health Systems and the Center for Reproductive Medicine, the targets in the wrongful death lawsuit that led to the state Supreme Court ruling, said it would not yet resume IVF treatments, the Times reported.

“At this time, we believe the law falls short of addressing the fertilized eggs currently stored across the state and leaves challenges for physicians and fertility clinics trying to help deserving families have children of their own,” a statement from the clinic said.

Experts agreed that the legal picture on IVF is still murky.

“The question that’s answered by this bill is, are our fertility clinics liable?” Clare Ryan, a professor of family law at the University of Alabama, told the Times. “It doesn’t address these bigger questions about, what is the child? When does the act of conception occur? What is the role of uterine implantation?”

“Republicans created this mess for themselves, and now they’re trying to contain the damage from it without dealing with the mess itself,” said Susan Pace Hamill, a University of Alabama law professor who specializes in the state Constitution, told the Times. “They are doing back somersaults to avoid disturbing directly anything the Alabama Supreme Court said.”

More information

Visit Yale Medicine for more on IVF.

SOURCE: New York Times

Cynthia Gyamfi-Bannerman, MD, from the University of California, San Diego, and colleagues evaluated whether administration of late preterm (34 to 36 completed weeks) corticosteroids (12mg of intramuscular betamethasone administered twice 24 hours apart) to persons at risk for late preterm delivery affected childhood neurodevelopmental outcomes. The analysis included 949 children aged 6 years and older followed from birth as part of the Maternal-Fetal Medicine Units Network cycle.

The researchers found no differences in the primary outcome of a general conceptual ability score less than 85, which occurred in 17.1% of the betamethasone group vs 18.5% of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73 to 1.22). Similarly, there no differences in secondary outcomes of gross motor skills, social responsiveness, or behavior.

“In this follow-up study of a randomized clinical trial, antenatal corticosteroids in persons at risk of late preterm delivery were not associated with adverse effects on childhood neurodevelopmental outcomes at age 6 years or older,” the authors write. “These data provide reassurance with regard to the administration of antenatal corticosteroids in the late preterm period.”

One author disclosed ties to the pharmaceutical industry.

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HealthDay News — For pregnant individuals at high risk for preeclampsia with a normal soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1:PlGF) ratio, aspirin discontinuation between 24 and 28 weeks of gestation is noninferior to aspirin continuation to 36 weeks of gestation for preventing preterm preeclampsia, according to a study published in the February 21 issue of the Journal of the American Medical Association.

Manel Mendoza, PhD, from the Universitat Autònoma de Barcelona in Spain, and colleagues conducted a multicenter randomized, phase 3, noninferiority trial in 9 maternity hospitals across Spain to examine whether aspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation to prevent preterm preeclampsia in pregnant individuals. Participants at high risk for preeclampsia during the first-trimester screening and an sFlt-1:PlGF ratio of 38 or less at 24 to 28 weeks of gestation were randomly assigned to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group; 473 and 463, respectively).

The researchers found that the incidence of preterm preeclampsia was 1.48 and 1.73% in the intervention and control groups, respectively (absolute difference, −0.25%; 95% CI, −1.86 to 1.36%), indicating noninferiority.

“The main strength of this study was that the novel evidence suggests that it may be unnecessary to continue aspirin until 36 weeks of gestation in all cases,” the authors write. “Earlier discontinuation could ultimately reduce the risk of bleeding complications and pregnancy complications at term.”

One author disclosed financial ties to Roche Diagnostics.

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Sonia Hernández‑Díaz, MD, Dr PH, from the Harvard TH Chan School of Public Health in Boston, and colleagues identified a population-based cohort of pregnant women and their children within 2 health care utilization databases. Exposure to specific antiseizure medications was defined based on prescription fills from gestational week 19 until delivery.

The researchers found that at 8 years of age, the estimated cumulative incidence of autism spectrum disorder was 1.9% for the 4,199,796 children who had not been exposed to antiseizure medications. On restriction to children born to mothers with epilepsy, the incidence was 4.2, 6.2, 10.5, and 4.1% with no exposure to antiseizure medications, exposure to topiramate, exposure to valproate, and exposure to lamotrigine, respectively. Compared with no exposure to antiseizure medications, propensity score-adjusted hazard ratios were 0.96 (95% CI, 0.56 to 1.65), 2.67 (95% CI, 1.69 to 4.20), and 1.00 (95% CI, 0.69 to 1.46) for exposure to topiramate, valproate, and lamotrigine, respectively.

“After adjustment for indication, the association was substantially attenuated for topiramate and lamotrigine, whereas a dose-dependent increased risk remained for valproate,” the authors write.

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“Fifty-one years ago today, the Supreme Court recognized a woman’s constitutional right to make deeply personal decisions with her doctor, free from the interference of politicians. Then, a year and a half ago, the [Supreme] Court made the extreme decision to overturn Roe and take away a constitutional right,” President Joe Biden said in a statement.

“As a result, tens of millions of women now live in states with extreme and dangerous abortion bans … In states across the country, women are being turned away from emergency rooms, forced to go to court to seek permission for the medical attention they need, and made to travel hundreds of miles for health care,” he added.

The new measures announced by the White House are multi-pronged: First, federal agencies will issue guidance to help make free contraceptives more available under the Affordable Care Act and to expand contraception access for federal employees. Meanwhile, the US Department of Health and Human Services (HHS) will also send letters to health insurers instructing them of their obligation to provide free birth control, the White House said in a news release.

The HHS has also created a new team that will enforce its interpretation of a law known as the Emergency Medical Treatment and Labor Act (EMTALA), which the Biden administration has said requires hospitals to provide emergency abortions nationwide, including in the 21 states where the procedure is now limited or banned.

“No American who believes in freedom should accept that women today have fewer rights to choose their health care than their mothers had 51 years ago,” HHS Secretary Xavier Becerra said in an agency news release.

“Abortion is health care. Contraception is health care. And health care decisions should be made by a patient with her doctor, not by politicians,” he added. “The Biden-Harris Administration is steadfast in the fight for reproductive freedom for all.”

As part of the administration’s new initiative, Biden will gather with senior officials for a meeting of his reproductive health task force on Monday, where he will be joined by several physicians who have practiced in states with abortion bans, the White House said.

The latest actions are part of Democrats’ continuing effort to focus on an issue that is popular with voters: Fifty-eight percent of all voters, including about 1 in 5 Republicans, trust Democrats more than Republicans on abortion, according to a November poll conducted by KFF, a health policy organization.

“Where abortion has been on the ballot, the American people have overwhelmingly voted to protect reproductive freedom,” Jennifer Klein, director of the White House’s Gender Policy Council, told reporters last week, the Washington Post reported.

She pointed to states such as Kansas and Ohio where voters last year sided with measures protecting abortion rights, the Post reported.

In addition to the measures announced Monday, Biden officials have said they are continuing to work with Congress to enact legislation that would guarantee a national right to abortion.

“As we’ve been really clear, the president, the vice president, everyone in the administration, the number one priority for all of us is working to pass a federal law that will restore the protections that were lost when Roe was overturned,” Klein said.

More information

The Center for Reproductive Rights has more on abortion access.

SOURCE: White House, news releases, Jan. 22, 2024; Washington Post

The order “will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health,” the White House said in a news release announcing the move. “These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women’s midlife health.”

While women comprise half of the US population, research into their health is lacking. In fact, the federal government only began mandating women be included in federally funded medical research in the 1990s, the Associated Press reported.

“We still know too little about how to effectively prevent, diagnose and treat a wide array of health conditions in women,” Dr Carolyn Mazure, head of the White House initiative on women’s health, told the AP.

The move comes as women’s reproductive rights across the country are being threatened following the Supreme Court’s overruling of Roe v. Wade.

President Biden and First Lady Jill Biden, who announced an initial $100 million in funding last month for women’s health, plan to announce the latest measures at a Women’s History Month reception at the White House on Monday. The measures will include the launch of a new effort at the National Institutes of Health (NIH) that will direct $200 million in 2025 to fund new, interdisciplinary women’s health research.

The NIH effort will also focus on identifying and rectifying research gaps in studying menopause and the treatment of menopausal symptoms, White House adviser Jennifer Klein told the AP.

The NIH tends to fund a lot of biomedical research, which helps doctors figure out how medications affect the human body and how to dose drugs safely, but that equation differs depending on gender.

Some conditions have different symptoms for men and women, such as heart disease. Others are more common in women, like Alzheimer’s disease, and some are unique to women, such as endometriosis, uterine cancers and fibroids found in the uterus. Regardless, it all needs to be studied further, Mazure said.

More information

The Office on Women’s Health has more on women’s health.

SOURCE: White House, news release, March 18, 2024; Associated Press

Cynthia A. Thomson, PhD, RD, from the Mel and Enid Zuckerman College of Public Health at the University of Arizona in Tucson, and colleagues examined long-term health outcomes among postmenopausal women in the Women’s Health Initiative CaD trial involving 36,282 women with no history of breast or colorectal cancer. Participants were randomly assigned to receive 1000mg calcium carbonate with 400 IU vitamin D₃ daily or placebo.

The researchers found that after a median cumulative follow-up of 22.3 years, women randomly assigned to CaD vs placebo had a reduction in cancer mortality (hazard ratio, 0.93), and an increase in CVD mortality (hazard ratio, 1.06). No overall effect was seen on other measures, including all-cause mortality. There was considerable variation observed in estimates of cancer incidence when stratified by whether participants reported supplement use before randomization, while no variation was seen for estimates in mortality, except for CVD mortality.

“Effects of vitamin D supplementation for cancer prevention may depend on achieving serum vitamin D concentrations above 50nmol/L,” the authors write. “Given the study design, we could not disentangle the added benefit or harms of supplementation with CaD in combination vs vitamin D alone, a topic worthy of future study.”

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Katherine Kortsmit, PhD, from the CDC in Atlanta, and colleagues used census and natality data to calculate abortion rates and ratios for 48 reporting areas, which voluntarily provided aggregate abortion data to the CDC; 47 of these reporting areas provided data each year during 2012 to 2021.

Overall, 625,978 abortions were reported to the CDC for 2021 from 48 reporting areas. The researchers found that 622,108 abortions were reported in 2021 among 47 reporting areas, with an abortion rate of 11.6 abortions per 1000 women aged 15 to 44 years and an abortion ratio of 204 per 1000 live births. The total number of abortions increased 5% from 2020 to 2021, the abortion rate increased 5%, and the abortion ratio increased 4%. From 2012 to 2021, there were decreases of 8, 11, and 1% in the total number of abortions, abortion rate, and abortion ratio, respectively. In 2021, women in their 20s accounted for 57.0% of abortions.

“Improvements in provider reimbursement and training, patient-centered counseling, youth-friendly services, and client awareness of available contraceptive methods might also help to improve contraceptive access, ensure equitable access to patient-centered contraceptive care, and promote equitable reproductive health in the United States,” the authors write.

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Joyce A. Martin, MPH, and Michelle J.K. Osterman, from the National Center for Health Statistics in Hyattsville, Maryland, used data from all birth certificates for singleton births registered in the US from 2014 to 2022 to examine the changes in the distribution of singleton births by gestational age. Gestational age was categorized as early preterm (less than 34 weeks), late preterm (34 to 36 weeks), total preterm (less than 37 weeks), early-term (37 to 38 weeks), full-term (39 to 40 weeks), and late- and postterm (41 weeks and later).

The researchers found that despite some fluctuations in most gestational age categories during the pandemic (2020 to 2022), there was a shift toward shorter gestational ages in trends from 2014 to 2022. Increases of 12 and 20% were seen in preterm and early-term birth rates, respectively, while declines of 6 and 28% were seen in full-term and late- and postterm births, respectively. Across maternal age and race and Hispanic-origin groups, shifts for each gestational age category were similar. By single week of gestation at term, the largest change was for 37 weeks, which had a 42% increase.

“This report demonstrates a shift from 2014 through 2022 across gestational age categories, with the largest changes occurring among early-term births, particularly those delivered at 37 weeks, and among late- and postterm births,” the authors write.

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Deborah Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, and colleagues describe 6 children who received very early nevirapine– or protease inhibitor-based ART (initiation within 48 hours of birth) and underwent analytical treatment interruption (ATI) to assess for remission.

The researchers found that the children underwent ATI at a median of 5.5 years old. Four achieved study-defined remission (absence of replicating virus for ≥48 weeks off ART) one through 80 weeks of ATI, at which point viral rebound occurred. The other three remained in remission for 48, 52, and 64 weeks, respectively. Viral rebound occurred 3 and 8 weeks after ATI in 2 children. Two children with rebound at 80 and 8 weeks experienced mild acute retroviral syndrome; during or following ATI, there were no other clinical or immunological events of concern reported. The children with rebound at 3 or 8 weeks had HIV RNA below the limit of detection at 8 and 20 weeks after resumption of ART. Two weeks after resuming ART, the child with rebound at 80 weeks had HIV-1 RNA 724 cp/mL.

“These results are groundbreaking for HIV remission and cure research, and they also point to the necessity of immediate neonatal testing and treatment initiation in health care settings for all infants potentially exposed to HIV in utero,” Persaud said in a statement.

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Eleni G. Jaswa, MD, from the University of California in San Francisco, and colleagues conducted a prospective cohort study, Assessing the Safety of Pregnancy During the Coronavirus Pandemic (ASPIRE), to examine whether in utero exposure to maternal COVID-19 vaccination is associated with differences in scores on the Ages and Stages Questionnaire, third edition (ASQ-3), at ages 12 and 18 months. A total of 2487 pregnant participants were enrolled at less than 10 weeks of gestation. Neurodevelopmental assessments were included for 2261 and 1940 infants aged 12 and 18 months, respectively.

The researchers found that 30.6% of 1541 exposed infants and 28.2% of 720 unexposed infants screened abnormally for developmental delay at 12 months; the corresponding prevalences were 20.1 and 23.2% of 1301 and 639 infants at 18 months, respectively. After adjustment for confounding variables, including maternal age, race, ethnicity, education, income, maternal depression, and anxiety, there was no difference seen in risk for abnormal ASQ-3 screened at 12 or 18 months. The results were not affected after further adjustment for preterm birth and infant sex.

“These data suggest that maternal vaccination against COVID-19 during pregnancy was safe from the perspective of offspring neurodevelopment through 18 months of age,” the authors write.

The ASPIRE Study was partially funded by pharmaceutical companies.

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The US Food and Drug Administration has certified the nation’s 2 largest pharmacy chains to dispense mifepristone, and they plan to make the medication available first in states where abortion is legal.

The chains will not dispense the medication by mail, they told news outlets.

Walgreens plans to start dispensing the abortion pill within the next week at a small number of pharmacies in New York, Pennsylvania, Massachusetts, California and Illinois, according to the company’s website.

“We are beginning a phased rollout in select locations to allow us to ensure quality, safety and privacy for our patients, providers and team members,” company spokesman Fraser Engerman told the New York Times.

CVS will first make the pill available in Massachusetts and Rhode Island pharmacies, the company told the Times.

Both companies said they will not dispense in states where the law is unclear, but they do plan to eventually expand into states where pharmacists are legally allowed to dispense mifepristone.

President Joe Biden immediately praised the announcement.

“Today is an important milestone in ensuring access to mifepristone, a drug that has been approved by the Food and Drug Administration as safe and effective for more than 20 years,” Biden said in a statement.

“With major retail pharmacy chains newly certified to dispense medication abortion, many women will soon have the option to pick up their prescription at a local, certified pharmacy, just as they would for any other medication,” Biden added.

The chains received their mifepristone certifications under new guidelines updated by the FDA in January 2023.

Prior to the FDA’s action, only certified health professionals could dispense the drug, and then only directly to a patient during a visit to a medical facility.

The pandemic first prompted a loosening of this requirement. People were allowed to order mifepristone through mail-order pharmacies, after the FDA said it would waive the in-person requirement.

“I encourage all pharmacies that want to pursue this option to seek certification,” Biden said.

The announcement comes as the US Supreme Court prepares to hear arguments that could restrict the availability of mifepristone.

Abortion opponents sued the FDA to remove mifepristone from the market, but an appeals court limited its ruling to restricting the distribution of mifepristone by mail and requiring an in-person doctor visit for its prescription.

If the Supreme Court upholds that decision, Walgreens and CVS could become important sites for women to access mifepristone after getting a prescription from a doctor or clinic.

Medication abortion typically requires two separate drugs, according to Planned Parenthood.

Mifepristone stops the pregnancy from growing by blocking a hormone called progesterone. Then a second medicine called misoprostol, taken within 48 hours, prompts cramping and bleeding to empty the uterus. Misoprostol is a widely available generic drug.

Taking misoprostol alone works to end a pregnancy 85% to 95% of the time, depending on how far along a woman is in her pregnancy, Planned Parenthood added.

More information

The U.S. Food and Drug Administration has more about mifepristone.

SOURCES: Walgreens, statement, March 1, 2024; White House, statement, March 1, 2024; New York Times, CNN, U.S. Food and Drug Administration

Felix Mhlanga, MBChB, from the University of Zimbabwe in Harare, and colleagues presented results from the third cohort of women initiating the DVR product during the second trimester of pregnancy as part of a phase 3b study. The analysis included healthy, HIV-uninfected pregnant women (ages 18 to 40 years) from South Africa, Uganda, Zimbabwe, and Malawi who were randomly assigned (4:1) to monthly DVR (202 participants) or TDF/FTC (49 participants).

The researchers noted 2 stillbirths and one miscarriage. Most deliveries were at term (96%), and pregnancy complications were uncommon. In 3 cases in the DVR arm, preterm premature rupture of membranes occurred. Overall, 11 infant participants had congenital anomalies (most commonly umbilical hernias), none of which was related to the study product. No HIV infections occurred in this cohort of women.

“These data, combined with the data from cohorts 1 and 2 and the safety data from women who used the DVR at the time of conception, support using DVR and TDF/FTC as HIV prevention options for pregnant people at risk of HIV,” the authors write.

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HealthDay News — Almost no dietary supplements in the US provide key nutrients at sufficient doses for pregnant women, according to a study published in the April issue of the American Journal of Clinical Nutrition.

Noting that most pregnant women in the US are at risk for inadequate intake of key nutrients from food alone during pregnancy, Katherine A. Sauder, PhD, from the University of Colorado Anschutz Medical Campus in Aurora, and colleague estimated the doses of supplementation needed to help most pregnant women achieve the recommended intake. From 2007 to 2019, 24-hour dietary recalls were conducted in 2450 pregnant participants aged 14 to 50 years. The usual intake of vitamins A and D, folate, calcium, iron, and ω-3 fatty acids was estimated from food alone.

For supplementation, the target dose was 198mcg or greater retinol activity equivalents of total vitamin A, 7 to 91mcg vitamin D, 169 to 720mcg dietary folate equivalents of folic acid, 383 to 943mg calcium, 13 to 22mg iron, and 59mg or greater ω-3 fatty acids. The researchers found that 69 products (33 prenatal) out of 20,547 dietary supplements contained all 6 nutrients, and 7 products (2 prenatal) contained target doses of 5 nutrients. Only 1 product contained target doses of all 6 nutrients, but it required 7 tablets per daily serving and cost about $200 per month.

“Reformulation or development of products that maximize the number of pregnant women receiving enough (but not too much) vitamin A, vitamin D, folic acid, calcium, iron, and ω-3 FAs is needed,” the authors write.

Two authors disclosed financial ties to the nutrition and other industries.

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Rachel L. Winer, PhD, MPH, from the University of Washington in Seattle, and colleagues examined the effectiveness of direct-mail and opt-in approaches for offering HPV self-sampling kits to individuals by cervical cancer screening history (due for screening, overdue, or unknown) in a randomized clinical trial involving women aged 30 to 64 years. Individuals stratified as due were randomly assigned to receive usual care (patient reminders and clinician electronic health record alerts), education (usual care plus educational materials), direct mail (usual care plus educational materials plus a mailed self-sampling kit), or opt-in (usual care plus educational materials and the option to request a kit; 3671; 3960; 1482; and 3956 participants, respectively). Individuals who were overdue were randomly assigned to usual care, education, or direct mail (5488; 1408; and 1415 participants, respectively). Individuals with unknown screening history were randomly assigned to usual care, education, or opt-in (2983; 3486; and 3506, respectively).

The researchers found that among those due for screening, screening completion was 14.1 and 3.5% higher in the direct-mail and opt-in groups, respectively, compared with receiving education alone. Screening completion was 16.9% higher in the direct-mail versus education-alone group among overdue individuals. Screening was 2.2% higher for the opt-in vs the education-alone group among those with unknown history.

“To increase screening adherence, systems implementing HPV self-sampling should prioritize direct-mail outreach for individuals who are due and overdue for screening,” the authors write.

Two authors disclosed ties to UnitedHealthcare.

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Samir Gupta, MD, from Sidra Medicine in Doha, Qatar, and colleagues conducted a multicenter, randomized, double-blind, placebo-controlled trial assessing early ibuprofen treatment (≤72 hours after birth) for a large PDA (diameter ≥1.5 mm with pulsatile flow) in extremely preterm infants. Overall, 326 and 327 infants were assigned to receive ibuprofen and placebo, respectively; 324 and 322 had data available for outcome analyses. A composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age was the primary outcome.

The researchers found that a primary outcome event occurred in 69.2 and 63.5% of infants in the ibuprofen and placebo groups, respectively (adjusted risk ratio, 1.09; 95% CI, 0.98 to 1.20; P =.10); 13.6 and 10.3 percent of infants, respectively, died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Moderate or severe bronchopulmonary dysplasia occurred in 64.2 and 59.3% of the ibuprofen and placebo groups, respectively, among the infants who survived to 36 weeks of postmenstrual age (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23).

“Our results are broadly consistent with those of other studies of early targeted treatment of PDA with ibuprofen that have not shown a convincing benefit with respect to clinical outcomes,” the authors write.

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HealthDay News — People are more likely to recommend that a pregnant family member or friend get vaccinated to protect the infant from respiratory syncytial virus (RSV) if they are shown information about the rigorous process a vaccine undergoes to receive approval or given a description of the risks of the illness, according to a new report from the Annenberg Public Policy Center.

Kathleen Hall Jamieson, PhD, from the Annenberg Public Policy Center at University of Pennsylvania in Philadelphia, and colleagues used data from the 11th wave of the Annenberg Science and Public Health knowledge survey, which included 1601 US adults and was collected May 31 to June 6, 2023. The researchers examined the current state of knowledge regarding RSV vaccines and misconceptions about vaccination during pregnancy through survey results and an embedded experiment.

The researchers found that overall, the public knew little about RSV including its prevalence, symptoms, and potential severity, or facts about the vaccine. Just 13% of respondents knew about the existence of an approved vaccine against RSV for older adults, while 20% knew there was not a US Food and Drug Administration-approved vaccine against RSV for those who are pregnant to benefit their newborns at the time of the survey. Overall, 19% of respondents knew there is currently not an FDA-approved vaccine against RSV for infants and children in the US. Among respondents shown a flowchart about the vaccine approval process, 57% were very or somewhat likely to recommend the RSV vaccine to a pregnant family member or friend versus 40% of those not shown the chart. Similarly, participants informed about the risks of RSV were also more likely (58%) to recommend the vaccine.

“Over the years the Food and Drug Administration and the Centers for Disease Control and Prevention have developed a sophisticated review system designed to protect the integrity of the data as well as the independence of the analysis on which the vaccination vetting and approval process relies,” Jamieson said in a statement. “The public would be well served if the press were to remind the public of this review process when a new vaccine is announced and vigilantly monitor it to ensure that it is doing its intended job well.”

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