Women’s Childbirth Experiences in the WILL Randomised Trial: A Mixed Methods Analysis

Chronic or gestational hypertension complicates 7% of
pregnancies, half of which will reach 37 weeks’ gestation. Observational data
suggest that early term birth (at 37 to 38 weeks) may reduce maternal
complications (e.g., preeclampsia), Caesareans, stillbirth and costs of
maternal fetal surveillance; however, early term birth may increase neonatal
morbidity. There are no high-quality data on which to base timing of birth for
this high-risk population.

The WILL trial (When to Induce Labour to Limit risk in pregnancy
hypertension) aimed to address the optimal timing of birth for women with
chronic or gestational hypertension at term gestational age, when women remain
well and there is no evidence of pre-eclampsia. WILL was a multicentre
randomised trial of 403 women with chronic or gestational hypertension, who
were randomised at 37+0–6 weeks’ gestational age to either ‘planned early term
birth at 38+0–3 weeks’ gestation’ (N = 201, intervention group) or ‘usual care
at term’ (N = 202, control group); the trial was stopped early by the funder
due to slower-than-anticipated recruitment during the COVID-19 pandemic. The
clinical outcomes and costs favoured the intervention group. While in the
intervention (vs. control) group, there was no difference in the co-primary
outcomes of ‘poor maternal outcome’ (severe hypertension, maternal death, or
maternal morbidity; 27, 13% vs. 24, 12%, respectively) or ‘neonatal unit
admission for ≥4 h’ (14, 7% vs. 14, 7%, respectively), or Caesarean births (58,
29% vs. 72, 36%, respectively), there was a significant reduction in
pre-eclampsia (56, 27.9% vs. 76, 37.6%, respectively) and costs for tests of
maternal or fetal wellbeing (102.84, 95% CI −136.65 to −67.78).

In addition to clinical outcomes and costs, patients’
experiences were evaluated in the WILL trial. As with all health policy, it is
important that timing of birth recommendations be associated with positive
psychosocial outcomes for women, particularly as dissatisfaction with the
childbirth experience has been associated with negative consequences, such as
on breastfeeding, infant bonding and postpartum mental health. In this article,
authors described the experiences of women in the WILL trial, as evaluated by
the Childbirth Experience Questionnaire (CEQ) and their associated free-text
comments.

In intervention (vs. control) groups, the CEQ was completed
by 177/202, 88.1% (vs. 180/202, 89.1%) participants, and 378 free-text comments
were made by 93/177, 52.5% (vs. 98/180, 54.4%) participants. There was no
significant difference in CEQ scores overall (3.1±0.4 vs. 3.1±0.4,
respectively) or by domain (‘Own capacity’ [2.8±0.5 vs. 2.7±0.5, respectively];
‘Professional support’ [3.7±0.5 vs. 3.7±0.6, respectively]; ‘Perceived safety’
[3.2±0.6 vs. 3.1±0.6, respectively]; and ‘Participation’ [2.6±0.7 vs.
2.7±0.6]). Most comments were positive (222/378, 58.7%), and about ‘Relational
care and care interactions’ (CEQ ‘Professional support’). Neither the number
nor positivity of comments appeared to differ between groups.

In this trial of 403 high-risk women with chronic or
gestational hypertension, randomisation to planned early term birth at 38+0–3
weeks (vs. usual care at term) resulted in a similar childbirth experience
overall, by CEQ domain, and whether labour induction or adverse outcomes had
occurred. Just over half of women who responded to the CEQ provided free-text
comments, and most were positive, particularly regarding ‘Relational care and
care interactions’ (CEQ ‘Professional support’ domain). Also, most comments
endorsed the ‘Conceptualising safety’ theme, even when labour induction did not
go as planned. However, it was clear that labour induction was not always
viewed positively, in both arms and across themes of ‘Capacity for autonomy
over care’, ‘Experiences of labour and birth’, and the less frequently-endorsed
themes of ‘Lack of shared decision-making’ and ‘Experience of participating in
research’. Repeatedly, women described logistical issues related to initiation
of labour induction, lack of information, the process not going as they had
expected, uncontrolled pain, and not always being listened to.

For women with chronic or gestational hypertension who
remain well at term gestational age, authors found no difference in childbirth
experience between women randomised to planned early term birth at 38+0–3
weeks’ gestation, compared with usual care at term. This was true regardless of
initiation of birth, mode of birth, or pregnancy outcome, and in directed
content analysis of free-text comments. Based on these findings, shared
decisions about the timing of birth may be more influenced by differences in
clinical outcomes and costs. Additionally, labour induction experiences may be
improved with good information sharing and preparation, to facilitate a sense
of ownership and control of labour.

Source: Sue Tohill, Katie Kirkham,
Eleni Gkini; BJOG: An International Journal of Obstetrics &
Gynaecology, 2025; 0:1–12 https://doi.org/10.1111/1471-0528.18257

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Higher levels of air pollution linked to worsening of sleep apnea: ERS Stu

People who have obstructive sleep apnoea (OSA) may suffer worse symptoms if they live in areas with higher levels of air pollution, according to a multi-national study presented at the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands .

Patients with OSA often snore loudly, their breathing starts and stops during the night, and they may wake up several times. Not only does this cause excessive sleepiness, but it can also increase the risk of high blood pressure, stroke, heart disease and type 2 diabetes. OSA is very common, but many people do not realise they have the condition.

The research was presented by Martino Pengo, Associate Professor from the University of Milano-Bicocca and clinician at Istituto Auxologico Italiano IRCCS, Milan, Italy. He told the Congress: “We know that OSA is more common in people who are older or overweight, but there’s growing concern that air pollution also might make the condition worse. However, previous studies, mostly focused on just one country, have produced mixed results. We wanted to look at this on a larger scale, across several European cities, to better understand if and how air pollution affects OSA.”

The study included data on 19,325 patients with OSA from 25 different cities in 14 countries [2]. All patients are taking part in a larger research project called the European Sleep Apnoea Database. As well as providing data on their age, sex, BMI and whether they smoke, all patients took part in a sleep study to measure the quality of their sleep and confirm a diagnosis of OSA, including recording pauses in breathing and drops in the level of oxygen in the blood.

Researchers combined this patient data with records of PM10 concentration in the air where each patient lives, taken from the Europe-wide Copernicus Atmosphere Monitoring Service. PM10 concentration is the amount of tiny particles, 10 micrometres or smaller, released into the air by vehicle exhausts and industrial processes, for example.

The analysis revealed that, overall, for every one unit increase in PM10, there was a modest but measurable increase in the patients’ apnoea hypopnea index (AHI). AHI is the number of apnoeas (when breathing stops) and hypopneas (when breathing is reduced) per hour during sleep. For example, among patients with low AHI (less than five) the average PM10 in the area where they live was relatively low (around 16 micrograms per cubic meter of air). In contrast, in patients with high AHI (five or more) the average PM10 was also higher (around 19 micrograms per cubic meter of air).

Researchers also found differences between the strength of the link between air pollution and OSA in different cities around Europe: for instance, in cities like Lisbon (Portugal), Paris (France), and Athens (Greece) the association was particularly strong.

Professor Pengo said: “We confirmed a statistically significant positive association between average long-term exposure to air pollution, specifically fine particles known as PM10, and the severity of obstructive sleep apnoea. Even after we took account for other factors that we know have an effect on OSA, we still found an average increase in the number of respiratory events per hour of sleep of 0.41 for every one unit increase in PM10. This effect may seem small for an individual, but across entire populations it can shift many people into higher-severity categories, making it meaningful from a public health perspective”.

“One of the most interesting findings was that the link between air pollution and OSA severity wasn’t the same in every European location. In some cities, the impact was stronger; in others, it was weaker or even absent. These regional differences might be due to things like local climate, the type of pollution or even how healthcare systems detect OSA.”

The researchers say they want to understand why the effects vary between cities and whether some people are more affected by pollution than others. They also hope to explore whether reducing pollution can improve sleep apnoea symptoms.

Professor Sophia Schiza is Head of the European Respiratory Society’s expert group on sleep disordered breathing, based at the University of Crete, Greece, and was not involved in the research. She said: “Obstructive sleep apnoea is a common condition. People who have OSA may know that they snore or wake up often in the night, and they may also feel sleepy during the day. There are also serious health risks associated with this condition. For people with OSA, especially those living in cities with high levels of air pollution, this study is important as it suggests pollution could be making their condition worse.

“For doctors caring for people with OSA, this research highlights the need to consider environmental factors like air quality alongside other risk factors. This study strengthens the connection between environmental health and sleep medicine. It reminds us that tackling air pollution isn’t just good for the planet, it’s also vital for our lungs and our sleep quality too.”

Reference:

Higher levels of air pollution linked to worsening of sleep apnea European Respiratory Society, Meeting: European Respiratory Society Congress.

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Acupuncture treatment improves disabling effects of chronic low back pain in older adults, claims research

According to a study funded by the National Institutes of Health (NIH), older Americans with chronic low back pain who received acupuncture had greater improvement in physical function and reduced pain than those who received usual medical care only, generally prescribed medications or physical therapy. Chronic low back pain is the leading cause of disability worldwide and affects over one-third of older adults in the United States. Treatment options range from pain-relieving drugs to complementary therapies, including acupuncture. There is an urgent need for safe, effective, and non-addictive pain management approaches.

“Of the different treatments we have for chronic low back pain, most have a somewhat modest effect. They often reduce pain by about a third at best and can help people function better,” said lead author Lynn L. DeBar, Ph.D., Kaiser Permanente distinguished investigator. “Our clinical results suggests that acupuncture is working as well as many things that are more familiar to people. We found that the size of this effect, while modest, was positive and sustained.”

The clinical trial, known as BackInAction, enrolled 800 participants, with results based upon self-reported pain-related disability assessments following treatment that either included or omitted acupuncture. Researchers looked at whether manual acupuncture needling, which is eligible for Medicare coverage, could improve function and reduce pain for older adults who have chronic or persistent low back pain.

Acupuncture, with its origins in traditional East Asian medicine, has gained in popularity in the United States since the 1970s. The manual acupuncture needling technique entails inserting fine needles into the skin at points that follow a prescribed anatomical grid. The practice provides various benefits, including reduced discomfort from back, joint or neck pain. While acupuncture has been found to be safe and effective for chronic low back pain in adults overall, few acupuncture studies have focused on adults 65 years of age and older.

Participants in BackInAction included men and women aged 65 and older with a medical history of low back pain for at least three months. All participants had health coverage and were not restricted from receiving usual medical care for their back pain. A third of those received up to 15 acupuncture treatments over three months (standard acupuncture treatment), and another third received an additional six acupuncture treatments (maintenance sessions) over the following three months.

At three study milestones — after three, six and 12 months from enrollment — participants provided self-assessment of their pain and physical limitations. Their agreement with any of 24 statements that describe everyday activities made difficult because of back pain contributed to the participant’s disability score. The researchers used additional tools for insights into pain levels, degree of physical functioning, depression and anxiety.

At the six-month and 12-month assessment, both groups who received acupuncture had greater reductions in pain disability than those who received usual medical care alone. The acupuncture-treated groups also had reduced pain intensity and greater physical function after six months as compared to participants who did not receive acupuncture. The researchers also reported that acupuncture treatment was associated with fewer anxiety symptoms as compared to usual medical care alone at the six and 12-month assessments.

“What sets the BackInAction study apart is that it focused specifically on adults 65 years of age and older, and it was pragmatically designed,” DeBar said. “We worked hard to involve adults in multiple regions of the country so that participant demographics were consistent with the U.S. census for older adults—and we worked with licensed acupuncturists in the community, who are most likely to deliver these services.”

The study authors suggest that access to acupuncture is important for older adults with chronic back pain and that if acupuncture practitioners could bill Medicare directly it could greatly improve access to such services.

“We saw very little in the way of adverse effects during the clinical trial,” said co-lead researcher Andrea J. Cook, Ph.D., Kaiser Permanente senior biostatistics investigator. “Older adults often are dealing with other medical problems in addition to back pain. Acupuncture offers a less invasive option that has a better safety profile than a lot of the common treatments for back pain in older adults.” 

Reference:

DeBar LL, Wellman RD, Justice M, et al. Acupuncture for Chronic Low Back Pain in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(9):e2531348. doi:10.1001/jamanetworkopen.2025.31348

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RSV vaccines are safe and effective, review finds

A new Cochrane review demonstrates that vaccines for respiratory syncytial virus (RSV) are both safe and effective in protecting vulnerable groups that are most at risk of serious illness, including older adults and infants.

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‘Staggering’ costs of e-scooter injuries are quantified for the first time for hospitals in Ireland

Injuries occurring to people who ride e-scooters cost Irish hospitals an average of €1,726 per patient, and researchers have calculated the total overall cost to one hospital in a single year was €128,650.

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Hypnosis can make ventilation masks more acceptable to patients with breathing problems

Hypnosis can significantly improve patients’ tolerance of masks to help them breathe when they are suffering from acute respiratory failure, according to a pilot study presented at the European Emergency Medicine Congress.

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Higher levels of air pollution linked to worsening of sleep apnea

People who have obstructive sleep apnea (OSA) may suffer worse symptoms if they live in areas with higher levels of air pollution, according to a multi-national study presented at the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands.

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Unplanned, premature, out-of-hospital births pose challenges for emergency team

The first detailed analysis of unplanned births that occurred outside the hospital setting in Austria has shown that, although such deliveries are rare, they pose challenges for emergency teams that attend, especially if babies are born prematurely.

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Mandibular Devices Effective for Severe Sleep Apnea with Hypertension: Study

Researchers have identified in a new study that mandibular advancement devices (MADs) are a valuable and acceptable treatment for patients with severe obstructive sleep apnea (OSA) and hypertension, offering significant improvements in sleep-related quality of life and blood pressure. Although continuous positive airway pressure (CPAP) is currently the gold standard treatment, this study demonstrates that MADs have cardiovascular benefits and improved patient compliance, and they can be an alternative in clinical practice. The study was published in the Journal of Dental Research by J. T. Colpani and fellow researchers.

This randomized trial substudy comprised 144 patients with severe OSA, who were assigned to MAD (n=73) or CPAP (n=71) treatment for 12 months. Measured outcomes were ambulatory BP, apnea-hypopnea index (AHI), quality of life related to sleep, cardiac MRI indexes, heart rhythm, biomarkers, and adverse events. Median nightly use was 5.4 hours (2.9–6.5) for MAD and 4.9 hours (4.0–6.0) for CPAP, with 56.1% of MAD users and 28.3% of CPAP users having ≥6 hours/night adherence.

Results

  • The AHI at baseline was 44.0 events/h in the MAD group and 50.7 events/h in the CPAP group.

  • At 6 months, AHI reduced to 20.9 events/h with MAD and 2.1 events/h with CPAP.

MAD treatment reduced significantly:

  • Asleep mean BP: −4.7 mm Hg (95% CI: −8.3 to −4.0; P = 0.015)

  • Asleep systolic BP: −2.0 mm Hg (95% CI: −10.0 to −4.0; P = 0.047)

  • Asleep diastolic BP: −4.0 mm Hg (95% CI: −9.0 to −3.0; P = 0.007)

Between-group differences benefited MAD compared with CPAP for:

  • Asleep mean BP: −3.70 mm Hg (95% CI: −7.40 to 0.00; P = 0.050)

  • Asleep systolic BP: −4.78 mm Hg (95% CI: −9.51 to 0.04; P = 0.048)

  • Both therapies enhanced quality of life related to sleep, but CPAP had a slightly greater effect on the Epworth Sleepiness Scale (Δ1.63; 95% CI: 0.45 to 2.81; P = 0.007).

  • There were no significant alterations in cardiac MRI parameters, ambulatory heart rhythm, or biomarkers for either group.

Adverse effects varied:

  • MAD users: jaw pain (14.8%), discomfort of teeth (8.2%)

  • CPAP users: dry mouth (50.8%), nasal congestion (23.0%), air leakage (29.5%)

This randomized study proved MADs to be an effective and acceptable substitute for CPAP in the case of patients with severe OSA and hypertension, especially for nocturnal blood pressure improvement and compliance. Although CPAP is still better at the suppression of apnea events, MADs can have larger cardiovascular benefits and are a valuable treatment strategy in the practice setting.

Reference:

Colpani, J. T., Ou, Y.-H., Kosasih, A. M., Lee, F. K. F., Chan, S.-P., Tan, H. H., Wong, R. C. W., Chin, C. W., Cistulli, P. A., & Lee, C.-H. (2025). Mandibular advancement device versus CPAP in severe obstructive sleep apnea. Journal of Dental Research, 00220345251361796. https://doi.org/10.1177/00220345251361796

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FDA Approves Palsonify for Acromegaly Treatment

The FDA has approved Palsonify™ (paltusotine) for adults with acromegaly who did not respond adequately to surgery or are not candidates for surgical treatment.

PALSONIFY, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly.

“With the FDA approval of our lead therapy Palsonify, today marks a new era for those living with acromegaly and also for Crinetics as a company,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We are very pleased to be fulfilling our commitment to transforming patient lives. This approval is the first to come from our deep pipeline of first-in-class, small molecule drugs. This would not be possible without the help and partnership of people living with acromegaly, their caretakers, our employees, and the clinical researchers and health care professionals who contributed to Palsonify’s successful development program. Thank you to all involved.”

The approval is based on data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials, which evaluated PALSONIFY’s safety and efficacy in previously treated and medically untreated adults with acromegaly. Across both trials, PALSONIFY consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.

Participants also reported significant reductions in signs and symptoms associated with acromegaly as measured by the Acromegaly Symptom Diary (ASD) — an FDA-aligned patient-reported outcome tool developed to capture the symptoms that matter to people living with acromegaly. Symptoms include headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling. PALSONIFY was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trials.

Long-term results from the open-label extension (OLE) phases of both trials were presented at this year’s Endocrine Society’s annual meeting, ENDO 2025, providing further evidence of PALSONIFY’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile. Ninety-one percent of patients from PATHFNDR-1 and 97 percent of completers from PATHFNDR-2 enrolled in the OLE.

“The PATHFNDR clinical development program set a new standard for acromegaly treatment by demonstrating the ability of Palsonify to drive both biochemical and symptom control, regardless of the degree of underlying disease severity,” said Dr. Shlomo Melmed, Executive Vice President of Medicine and Health Sciences and Dean of the Medical Faculty at Cedars-Sinai. “The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with a rapid action and durable response that can consistently manage acromegaly.”

“For people living with acromegaly, treatment once meant burdensome injections, breakthrough symptoms, and lifestyle sacrifices just to stay on track,” said Jill Sisco, President of Acromegaly Community. “What matters most to our community – maintaining consistent control so the disease doesn’t control us – led us to partner with the FDA on Externally Led Patient-Focused Drug Development meetings. This new treatment reflects that our voices have been heard in shaping the next generation of acromegaly care.”

PALSONIFY is expected to be available in the U.S. in early October. Crinetics is ensuring broad access to PALSONIFY by working closely with payers, healthcare providers, and patient advocacy organizations to support those who may benefit from this treatment.

As part of this commitment, Crinetics has launched CrinetiCARE®, a comprehensive support program designed to assist people living with acromegaly throughout their treatment journey. CrinetiCARE provides disease and product education, benefit verification, financial assistance resources, and access to dedicated nurse educators who can offer support with treatment onboarding and ongoing adherence. 

A Marketing Authorization Application (MAA) for paltusotine in acromegaly is currently under review for use in the European Union, and the current timeline for the Committee for Medicinal Products and Human Use (CHMP) opinion is the first half of 2026. Crinetics is in partnership with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize paltusotine for acromegaly in Japan.

Paltusotine is also being evaluated for the treatment of carcinoid syndrome in the pivotal Phase 3 CAREFNDR trial.

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