Antenatal physical activity interventions not tied to improved pregnancy outcomes: Study

Multiple systematic reviews and meta-analyses have
considered the question of whether antenatal physical activity, compared with
no such intervention, can improve pregnancy outcomes. Reported benefits of a
physical activity intervention include a reduction in gestational weight gain
and the risk of adverse pregnancy outcomes such as preeclampsia and gestational
diabetes mellitus (GDM). Such reviews have informed national and international
pregnancy care guidelines, with recommendations that pregnant women engage in
regular physical activity in pregnancy.

The principle of systematic reviews and meta-analyses is to
synthesise the available evidence, generating an aggregate effect estimate from
multiple studies. As part of this process, assessment of individual trial
quality is generally undertaken, commonly utilising the Cochrane Risk of Bias
tool 2.0, to assess risk of bias across multiple domains, including the impact
of missing outcome data. A central tenet of a rigorous randomised trial is the
inclusion of outcome data from all participants recruited and randomised in an
intention-to-treat (ITT) analysis. Failure to undertake an ITT analysis
introduces bias reflecting not only the extent of missing outcomes but also the
degree of “missingness”, which can be related to the nature of the
intervention. This is of particular relevance when considering physical
activity interventions, where the underlying characteristics and clinical
outcomes of those who comply are likely different from those who do not. Furthermore,
exclusion of participants who are non-compliant with an intervention limits the
generalisability of the findings into clinical practice. The aim was to conduct
a methodologically rigorous systematic review to evaluate physical activity
interventions in pregnancy on clinical pregnancy outcomes and to assess the
impact of including studies at increasing risk of bias on the validity of
recommendations for clinical practice guidelines.

This systematic review considered all randomised trials that
evaluated the effect of an antenatal physical activity intervention alone
(i.e., the intervention did not include dietary or behavioural components). Systematic
search of PubMed, PubMed Central, Ovid Medline, Embase, Cochrane Central
Register of Controlled Trials, and CINAHL from inception to 14 December 2023. Trial
quality was assessed using the Cochrane Risk of Bias tool. Independent of this,
studies were grouped based on degree of deviation from the intention to treat
principle. Sequential meta-analysis was performed in which greater degrees of
potential bias were allowed. Between intervention group comparisons used,
relative risks or mean differences with 95% confidence intervals for
dichotomous outcomes and continuous outcomes, respectively.

Overall, the quality of trial reporting was low. Only 5
trials (12.5%) were performed and analysed in keeping with the intention to
treat principle. When considering only those trials performed rigorously, there
was no evidence that antenatal physical activity improves pregnancy outcomes or
limits gestational weight gain (WMD −0.60kg; 95% CI −2.17, 0.98 WMD −0.60kg;
95% CI −2.17, 0.98).

Authors found no evidence that antenatal physical activity
is associated with improved pregnancy outcomes or reduced gestational weight
gain when considering only trials considered to have no or negligible risk of
bias. The effect of including trials with increasing potential for bias shifted
the estimates of effect further from the null while simultaneously introducing
greater heterogeneity.

Study findings are in contrast with those of published
systematic reviews and meta-analyses that have been used to inform national and
international guidelines for pregnancy care. In particular, recently published
systematic reviews and meta-analyses have reported that antenatal physical
activity interventions are associated with a reduction in gestational diabetes,
hypertensive disorders of pregnancy, and gestational weight gain. These
aggregate data meta-analyses included all trials, irrespective of individual
trial risk of bias or rigour.

Authors have demonstrated in review that a small minority of
randomised trials have been conducted in a methodologically rigorous way, the
majority of trials having substantial risk of bias, particularly in relation to
performing an ITT analysis. When considering only trials at no or negligible
risk of bias, there is no effect of antenatal physical activity interventions
on gestational weight gain or pregnancy and birth outcomes for women and their
infants. In contrast, the inclusion of trials with significant methodological
flaws results in misleading findings of benefit. Furthermore, almost half of
the trials they identified recruited fewer than 100 women. It is well known
that smaller studies often show different, commonly larger, treatment effects
than those reported by larger randomised trials. Smaller studies, particularly
those with fewer than 100 participants, have been shown to inappropriately skew
aggregate data meta-analysis results towards beneficial effects. This has
implications for evidence-based clinical practice guidelines that rely on
systematic reviews and meta-analyses suffering from artificially inflated
effect estimate.

Study findings cast doubt on the validity of national and
international clinical practice guidelines recommending antenatal physical
activity for improvement of pregnancy outcomes. A rigorous assessment of trial
quality is required prior to incorporation of evidence synthesis into such clinical
practice guidelines, as study found a significant proportion of included trials
were of poor quality and biased aggregate estimates of effect.

Source: Amanda J. Poprzeczny,
Andrea R. Deussen, Megan Mitchell; BJOG: An International
Journal of Obstetrics & Gynaecology, 2025; 0:1–15 https://doi.org/10.1111/1471-0528.18084

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Ultrasound during surgery to unblock arteries is a safe and effective way to lower stroke risk

Using ultrasound during surgery to unblock carotid arteries is a safe and effective way to significantly reduce the risk of stroke and death, finds a trial published by The BMJ today.

The technique, called sonolysis, uses continuous ultrasound directly on the artery to help break up blood clots during carotid endarterectomy – a procedure to remove fatty deposits from carotid arteries that supply blood to the brain, face, and neck.

Pilot studies have shown a potential positive effect of sonolysis on the risk of stroke during this type of surgery, so researchers wanted to test this in a randomised controlled trial.

Their findings are based on 1,004 patients (average age 68; 31% female) due to have carotid endarterectomy at 16 centres in three European counties (Czech Republic, Slovakia, and Austria) between 20 August 2015 and 14 October 2020.

A total of 507 patients were randomly assigned to the sonolysis group and 497 to the control group (sham sonolysis). All patients had carotid endarterectomy within 9 days of randomisation.

The main measure of interest was a combination of ischaemic stroke, transient ischemic stroke (TIA or ‘mini-stroke’), or death within 30 days of surgery, verified by a stroke neurologist.

Potentially influential factors such as age, sex, conditions such as diabetes and high blood pressure, medication use, and smoking history were also taken into account.

Eleven (2.2%) of patients in the sonolysis group experienced ischaemic stroke, transient ischemic stroke or death within 30 days of surgery compared with 38 patients (7.6%) in the control group – a statistically significant risk difference of 5.5%.

A total of 460 patients also received a brain scan before and one day after surgery: 236 in the sonolysis group and 224 in the control group. New brain lesions were detected in 20 (8.5%) patients in the sonolysis group and in 39 (17.4%) patients in the control group – a statistically significant risk difference of 8.9%.

Sonolysis was found to be safe, and 94.4% of patients in the sonolysis group were free from serious adverse events 30 days after the procedure.

However, death within 30 days and over the course of one year did not differ significantly between groups.

The exact way in which sonolysis helps prevent stroke remains unclear, but it’s thought that ultrasound waves can break apart blood clots and speed up fibrinolysis, the body’s natural anti-clotting process, explain the authors.

They acknowledge that the sonographer could not be blinded, as only standard ultrasound machines were used. However, they point out that patients and all other health professionals involved in the trial were unaware of the group assignments.

As such, they conclude that sonolysis “has the potential to make carotid endarterectomy safer with a higher benefit for patients with carotid stenosis compared with the best medical treatment, especially in patients with asymptomatic carotid stenosis.”

This trial has several strengths, but some questions surround the study design and results and should be considered before widespread adoption of this technique, says a US vascular surgeon in a linked editorial.

However, he adds that resolution of the above concerns, along with a cost effectiveness calculation, “can then inform whether this exciting new application of an established technology can improve care for patients undergoing carotid endarterectomy.”

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Post-trauma drug blocks fear response in female mice, study shows

A new report published in Brain Medicine reveals that a single dose of the drug Osanetant, administered shortly after a traumatic event, significantly dampens fear expression in female mice. The findings provide strong preclinical support for using Nk3R antagonism as a sex-specific, time-sensitive intervention to reduce the risk of posttraumatic stress disorder (PTSD).

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Public housing smoking ban can reduce heart attacks and strokes

A paper, “Evaluation of Federally Mandated Smoke-Free Housing Policy and Health Outcomes Among Adults Over the Age of 50 in Low-Income, Public Housing in New York City, 2015-2022,” published in Nicotine & Tobacco Research finds that a 2018 U.S. ban on smoking in public housing led to a reduction in hospitalizations for cardiovascular problems.

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One in 3,000 people at risk of punctured lung from faulty gene—almost 100 times higher than previous estimate

As many as one in 3,000 people could be carrying a faulty gene that significantly increases their risk of a punctured lung, according to new estimates from Cambridge researchers. Previous estimates had put this risk closer to one in 200,000 people.

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The thalamus: A potential therapeutic target for neurodevelopmental disorders

Years ago, as a neurology resident, Chinfei Chen, MD, Ph.D., cared for a 20-year-old woman who had experienced a very small stroke, affecting only the thalamus.

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Exploring the link between blood flow, brain stiffness and Alzheimer’s risk

Researchers have discovered that increased blood flow leads to stiffness in the hippocampus, a region of the brain that plays important roles in learning and memory. The hippocampus is one of the first areas in the brain affected by Alzheimer’s disease, a brain disorder that erodes memory and thinking skills, as well as the ability to do daily tasks.

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FIR against Fake doctor who worked in BJP’s Jabalpur medical cell

Jabalpur: Days after a fake doctor case emerged in Madhya Pradesh, police have registered a cheating case against another bogus doctor, who also served as co-convenor of the BJP Jabalpur district medical cell. He is accused of working in a government hospital using a counterfeit Ayush degree, police said on Monday. 

The case against him was registered two days before Monday’s arrest of a “fake” cardiologist who practised at Damoh Missionary Hospital in Madhya Pradesh. As per a complaint filed with the National Human Rights Commission, seven heart patients treated by him have died.

Police filed the FIR against the bogus doctor following a court order in Jabalpur district.

“An FIR of cheating has been registered against Shubham Awasthi, who has been accused of using a fake Ayush degree and working in government-run Seth Govind Das Jabalpur district hospital (formerly known as Victoria Hospital). The case was registered on basis of the court order,” Civil Lines Police Station Inspector Nehru Singh Khandate told PTI.

Also Read:Fake doctor posing as UK Cardiologist performs Heart Surgeries, kills 7

The case is under investigation, he added.  

When contacted, BJP Jabalpur city chief Ratnesh Sonkar asserted action will be taken against Awasthi as per party guidelines after they get official confirmation of the case.

“After coming to know about the incident this morning via a media report, I have personally sought authentic details of the case. The BJP doesn’t tolerate such things… 1001 per cent action will be taken,” he insisted.

The ruling party admitted the bogus physician was associated with it, but was removed from his post two years ago.

“Yes, he was BJP Jabalpur district medical cell co-convenor. He was relieved from the post two years ago following some accusations against him,” MP BJP co-convenor of medical cell and dentist Ashwini Trivedi informed, reports PTI.

When contacted, the complainant in the case, Shailendra Bari, said, “I learnt about Shubham Awasthi working in the district hospital as a bogus ayurvedic doctor (with Ayush) degree for one year in 2020-21 from my friend who was admitted to the hospital.

“My friend, who is no more, heard some doctors talking about a black sheep in their flock. Thereafter, I sought his educational documents under the Right to Information Act (RTI),” he added.

After getting to know of this development, Awasthi (40) resigned from the hospital, Bari said.

“On receipt of Awasthi’s educational documents, I applied under the RTI to the university and government ayurvedic college to know the duration of his studies. Both the university and the college replied no such student had been to their institute,” Bari said.

He said he later lodged a police complaint, but no action was taken.

“Later, I filed a complaint in the district court for action against Awasthi,” Bari said.

The court of Judicial Magistrate First Class on February 14 directed the Civil Lines police station to take up investigation into the matter, he added.

Also Read:Quack on the run after botched surgery leads to woman’s death

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NEET MDS 2025 exam to have time-bound sections, Demo test live from tomorrow

New Delhi- The National Board of Examinations in Medical Sciences (NBEMS) has notified about the compulsory time bound sections in the National Eligibility and Entrance Test-Master of Dental Surgery (NEET-MDS) 2025 question paper through an official notice.

As per the notice, the NEET-MDS 2025 question paper will be divided into two timed parts (A and B) in the question paper. Part A will have 100 questions and time will be allotted for 75 minutes, while Part B will have 140 questions and time will be allotted for 105 minutes.

Candidates will be restricted from proceeding to the next part until the time allotted for the previous part is over. They will not be allowed to review the questions/modify answers after the completion of the allotted time for that part. The questions of the next part will start automatically after the completion of the allotted time for the previous part, the notice said.

Also Read: NBE Reopens NEET MDS 2025 Registration window, Apply NOW

Earlier, NBEMS decided to introduce mandatory timed sections in all NBEMS MCQ-based exams to enhance the security and sanctity of the exams in view of the emerging threats during the process. As a result, exams like NEET-PG, NEET-MDS, NEET-SS, FMGE, DNB-PDCET, GPAT, DPEE, FDST and FET that are conducted on computer-based platforms will have mandatory timed sections.

Meanwhile, candidates will be able to access the demo test on the NBEMS website under the NEET MDS 2025 application link webpage from tomorrow, i.e. 09 April 2025. The NEET MDS Dental entrance examination for the academic year 2025 will be conducted on April 19, 2025, by NBEMS on a computer-based platform at various exam centres across the country.

Medical Dialogues had earlier reported that the Dental Council of India (DCI) extended the last date to complete the internship to become eligible for NEET-MDS 2025 to June 30, 2025.

To view the notice, click the link below

https://medicaldialogues.in/pdf_upload/nbemsjpg-282112.pdf

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Janssen-Cilag International gets European Commission nod for subcutaneous Rybrevant for advanced EGFR-mutated non-small cell lung cancer

Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has received approval from the European Commission (EC) for an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT (amivantamab), in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards.

This approval follows the recent presentation of final overall survival (OS) results from the Phase 3 MARIPOSA study (NCT04487080), at the 2025 European Lung Cancer Congress (ELCC), showing statistically superior OS with intravenous (IV) amivantamab plus lazertinib versus osimertinib monotherapy in the first-line treatment of patients with advanced EGFR ex19del or L858R substitution mutated NSCLC (hazard ratio [HR], 0.75; 95 percent Confidence Interval [CI], 0.61-0.92; P<0.005).

“While great strides have been made in the treatment of EGFR-mutated non-small cell lung cancer, a critical need still exists for treatment approaches that are not only effective but also more convenient for patients, while optimising experience in the clinic,” said Silvia Novello, M.D., Ph.D., Professor of Medical Oncology in the Oncology Department at San Luigi Hospital in Orbassano, University of Turin, Italy. “The approval of subcutaneous amivantamab will have a meaningful impact on clinical practice, offering patients greater convenience and an improved treatment experience, without compromising on the well-established efficacy of intravenous amivantamab.”

The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669), which evaluated non-inferiority of pharmacokinetics (PK) in addition to efficacy and safety of SC amivantamab (administered via manual injection) compared to IV amivantamab (the already approved route of administration), both in combination with lazertinib, in patients with EGFR-mutated advanced or metastatic NSCLC after disease progression on osimertinib and platinum-based chemotherapy. The study demonstrated that SC amivantamab was non-inferior to IV amivantamab, meeting both co-primary PK endpoints as measured by amivantamab levels in the blood (Ctrough and area under the serum concentration time curve from Cycle 2 day 1 to 15). At a median follow-up of 7 months, the overall response rate (a secondary endpoint) was 30 percent (95 percent confidence interval [CI], 24–37) in the SC arm and 33 percent (95 percent CI, 26–39) for IV (relative risk, 0.92; 95 percent CI, 0.70–1.23; P=0.001), meeting the non-inferiority criteria.

Administration time for SC amivantamab was approximately five minutes, and results showed a five-fold reduction in infusion-related reactions (IRRs) compared to IV administration. These results were featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology.

“The approval of subcutaneous amivantamab represents a welcome improvement of the treatment experience for both patients living with EGFR-mutated advanced non-small cell lung cancer and the healthcare professionals who support them,” said Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “This advancement presents an important opportunity to reduce the treatment burden, improve quality of life and give patients more time to focus on what truly matters to them.”

The rate of IRRs for patients treated with SC amivantamab combined with lazertinib was shown to be approximately five-fold lower than that observed with the IV formulation (13 percent vs 66 percent, respectively). The majority of IRRs were grades 1 and 2, with one patient experiencing a grade 3 IRR in the SC arm. Preventive blood thinning (prophylactic anticoagulation) was used in most patients in the PALOMA-3 study. Patients receiving prophylactic anticoagulation had lower rates of venous thromboembolic events (VTEs) (10 percent) than those who did not receive prophylaxis (21 percent). Furthermore, VTE incidence was numerically lower in the SC arm vs the IV arm (9 percent vs 14 percent) regardless of anticoagulation status. Severe bleeding risk (grade 3 to 4) was low among patients receiving anticoagulants in both the SC (2 percent) and IV (0.6 percent) arms. Otherwise, the overall safety profile of SC amivantamab is consistent with the known profile of IV administration.

“At Johnson & Johnson, we are dedicated to patient-centered innovation in our mission to address the critical unmet needs in lung cancer treatment and care,” said Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. “Our ongoing focus on advancing the clinical development programme for amivantamab reflects our confidence in its potential to become a standard of care for EGFR-and MET-driven lung cancer.”

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