Pregnancy
Round up: New insulin delivery technology supports healthier pregnancies and more
Femtech World explores the latest research and technology developments in the world of women’s health.
New insulin delivery technology supports healthier pregnancies
An international study has found new insulin delivery technology helps control glucose levels during pregnancy for those with Type 1 diabetes, which is crucial to the health of women and their newborns.
The technology, known as automated insulin delivery (AID), mimics a healthy pancreas. The system automatically adjusts the amount of insulin given by a pump in real-time, based on current and predicted glucose levels.
In a multicenter clinical trial, the researchers evaluated the impact of a hybrid closed-loop (HCL) insulin therapy treatment regime with standard insulin injections or an insulin pump that was not automated, along with continuous glucose monitoring.
“Keeping blood glucose in the optimal range for pregnancy is exceptionally challenging when someone has Type 1 diabetes, despite their best efforts and the support of dedicated health care clinics,” says Dr Denice Feig, MD, the study’s other co-principal investigator.
Risks associated with Type 1 diabetes in pregnancy can include increased chances of miscarriage, preeclampsia, which involves dangerous spike in blood pressure, and other significant health concerns.
Newborns of pregnant women with Type 1 diabetes are more likely to be born excessively large or early and have low blood glucose at birth and are at higher risk of birth defects.
“The study found this AID system worked in pregnancy.
“It resulted in a three hours per day improvement in the time spent in the desired glucose range compared to the standard delivery with insulin injections or regular insulin pumps,” says Donovan.
“This is very important because we have learned from other larger studies that every 72 minute per day increase, with glucose in the desired range during pregnancy, is associated with reduction in newborn complications.”
The AID system used in the study is known as a Tandem t:slim X2 insulin pump with Control-IQ technology.
The study found those using the AID spent more time in a healthy glucose level range and less time below and above the healthy range.
The improvement in blood sugar control was immediate and persisted throughout the pregnancy. These results were found at all 14 sites involved in the trial.
Widely-used technique for assessing IVF embryos may be flawed
A test deployed in many fertility clinics to assess the viability of embryos for use in IVF is likely to overestimate the number of embryos with abnormalities, a new study has suggested.
Using a new technique for imaging embryos in real time, a team led by scientists at the Loke Centre for Trophoblast Research, University of Cambridge, showed that abnormalities can arise at a later stage of embryo development than previously thought.
This means that the tests used in some clinics may be finding errors in cells that will go on to develop into the placenta – and abnormalities in placental cells are less likely to affect the health of the fetus.
When abnormalities are detected, the embryo may be deemed inviable and discarded, meaning patients may need to go through another cycle of treatment, which can prove costly.
So-called pre-implantation genetic testing for aneuploidy is a treatment ‘add on’ that may be offered to older women and those with a history of recurrent miscarriages or multiple IVF failures.
Researchers at the Loke Centre for Trophoblast Research, Cambridge, are interested in how early human embryos develop before implantation in the womb.
This is because in assisted conception, as many as nine in ten embryos fail to develop to a stage where they can be transferred to the womb.
To help understand development of the embryo at this early stage, Professor Niakan and colleagues, in collaboration with researchers at the Francis Crick Institute, developed a new, state-of-the-art method for watching embryos live in high resolution.
The new imaging technique involves tagging DNA inside the cell nucleus with a fluorescent protein, making it visible under a microscope.
The researchers then use an imaging technique known as light-sheet microscopy to observe the embryos in 3D as they developed without damaging them.
Of the 13 embryos analysed by the team, 10 per cent of the cells contained chromosomal abnormalities.
These arose from problems when DNA was being copied between cells, for example when chromosomes did not move properly during division or when a cell divides into three, rather than two.
Because these abnormalities arise at a relatively late stage of the embryo’s development, they appear in the outer layer of the blastocyst, which develops into the placenta – and it is from this layer that biopsies are taken for pre-genetic testing for aneuploidy.
Professor Niakan’s team is now studying cells in the inner layer to see whether such spontaneous abnormalities can also arise there.
In mice, fertility treatments linked to higher mutations than natural conception
Mice pups conceived with IVF in the lab have slightly increased rates of DNA errors, or mutations, compared to pups conceived naturally.
While the results from this new study do not directly apply to humans, they highlight the importance of understanding how fertility treatments affect an offspring’s DNA.
For the study, the researchers compared genome sequences of lab mice conceived naturally and mice conceived through assisted reproductive technologies, including hormone treatments, IVF, and embryo transfer.
They discovered pups born through these fertility treatments had about 30 per cent more new single-nucleotide variants, or tiny changes in DNA sequences.
Nucleotides are DNA’s building blocks or “letters.”
Arranged in specific sequences, these letters compose the instructions cells use to grow and function.
Single-nucleotide variants are simply genetic differences (or mutations) involving a change in just one DNA letter. They can occur when cells replicate their DNA.
The mutations observed in the study are unlikely to be harmful.
Scientists estimate that fewer than 2 per cent of new mutations arising in a genome are deleterious or have an impact on an individual’s phenotype or disease susceptibility.
The mutations appeared spread across the genome, rather than clustered in particular genes.
The timing of when these new mutations appeared in early embryos also looked similar between fertility-treated and natural groups, implying that fertility treatment increases the overall chance of new DNA changes but does not impact when they occur during development.
Even with a 30 per cent increase in new mutations, the absolute number of harmful new mutations per mouse remains low.
For about every 50 mice conceived with IVF, scientists expect roughly one additional harmful DNA change compared to natural conception.
That is one problematic change out of many possible ones, since the mouse genome is about 2.7 billion DNA letters long.
A similar effect is expected if the male parent’s age increased by about 30 weeks, the researchers explained, since paternal age is a major driver of mutation rates in mammals.
The biological mechanisms underlying these genetic changes are not clear.
Further research is needed to study whether the new mutations come from a specific step in the IVF process or from the combined effects of several steps.
One possible factor is the use of hormone treatments that stimulate the ovaries, since these hormones push eggs to restart meiosis, a stage of cell division known to be prone to mistakes.
Other aspects of the fertility treatment protocol could also play a role, such as physical handling of embryos or the chemical conditions of the lab culture environment.
The study does not show whether the same effect happens in humans. Fertility procedures vary between mice and humans, and both have different reproductive biology.
For example, mice do not menstruate. Also, people seeking IVF will likely encounter environmental factors that may already have affected their genetics.
Light exercise and less sitting may reduce pregnant women’s risk of serious blood pressure complications, according to a new study.
Researchers have proposed a daily activity and sleep guide that they say was linked to a nearly 30 per cent lower risk of hypertensive disorders of pregnancy.
The suggested pattern includes fewer than eight hours of sedentary time, at least seven hours of light physical activity, around 22 minutes of more intense activity and nearly nine hours of sleep.
The University of Iowa-led study examined the daily behaviours of 470 pregnant women across all stages of pregnancy.
Participants wore monitors that measured physical activity over 24-hour periods and recorded how long they spent asleep.
Hypertensive disorders of pregnancy include chronic high blood pressure, gestational hypertension and pre-eclampsia.
Gestational hypertension is high blood pressure that develops during pregnancy, while pre-eclampsia is a potentially serious condition involving high blood pressure and signs that organs may be affected.
Sedentary behaviour means being mostly inactive, such as sitting or lying down.
Light physical activity can include casual walking, moving around the home or standing.
Moderate to vigorous activity includes movement such as brisk walking, where breathing and heart rate increase.
Kara Whitaker, associate professor in the department of health, sport, and human physiology at Iowa and corresponding author of the study, said: “We are identifying the optimal composition of movement behaviours across the day associated with the lowest risk of developing HDP and the most improved health outcomes.
“This blueprint holds for each and every trimester of pregnancy.”
Study participants were enrolled at sites in Iowa City, Pittsburgh and Morgantown, West Virginia.
The women wore activity and sleep monitors for at least one week during each trimester of pregnancy.
Four in five participants were non-Hispanic white and nearly a quarter lived in rural areas.
The data showed a steep rise in risk among pregnant women who were sedentary for more than 10 hours a day.
Women who increased light physical activity to at least four hours a day reduced their risk of hypertensive disorders of pregnancy to 15 per cent from 30 per cent.
Whitaker said: “Just moving around more seems to have significant health benefits.
“And I think it also may be a more feasible target for women who are pregnant who are not exercising regularly.”
The researchers said they were surprised that longer durations of moderate to vigorous physical activity did not appear to provide additional benefit.
Sleep beyond a certain duration also did not appear to bring major further benefits.
Whitaker said: “Through this study, we are providing evidence that reducing sedentary behaviour and engaging in light physical activity are important, and maybe more important, when it comes to pregnancy and health.”
The findings may be relevant beyond pregnancy because clinical research has shown that women who develop hypertensive disorders of pregnancy are more than twice as likely to develop heart disease later in life.
Cardiovascular disease includes conditions affecting the heart and blood vessels, such as heart disease and stroke.
Whitaker said: “We know that cardiovascular disease is the number one killer of women, and if we can intervene in pregnancy and prevent women from developing a hypertensive disorder of pregnancy, we are putting them on a better trajectory, away from cardiovascular disease and toward more optimal cardiovascular health.”
The study was published online on June 10.
A second study, published online on May 27, looked more closely at the ratio and type of sedentary behaviour and light physical activity linked to a lower risk of hypertensive disorders of pregnancy.
Whitaker is a lead co-author on that study.
Co-authors in the June 10 study include Alex Crisp, Jaemyung Kim, Karina Smith, Donna Santillan, Mark Santillan and Bridget Zimmerman, from Iowa; Jacob Gallagher, from Iowa State University; Melissa Jones, from Oakland University in Michigan; Bethany Barone Gibbs, Katrina Wilhite, Alexis Thrower and Iqra Sheikh, from West Virginia University; and Sabera Rahman, Janet Catov, Christopher Kline and Maisa Feghali, from the University of Pittsburgh.
The National Institutes of Health, the University of Iowa Institute for Clinical and Translational Science, the University of Pittsburgh Clinical and Translational Science Institute and the West Virginia Clinical and Translational Science Institute funded the research.
A £50m maternity consortium will bring together UK clinicians, researchers and communities to tackle the most critical gaps in maternal care.
Funding from the National Institute for Health and Care Research has established the NIHR Inequalities Challenge: Maternity Disparities Consortium under the leadership of the University of Birmingham and Newcastle University.
Higher education bodies, NHS organisations, community groups and voluntary organisations from across the UK will work together through the programme.
The NIHR has committed £50m over five years to support research led by clinicians, researchers and communities across the consortium.
Professor Joht Singh Chandan, consortium co-lead for research at the University of Birmingham, said: “National attention on maternity safety and equity has never been greater, but ambition must now be matched by evidence and implementation.
“Through this consortium, we will work across the UK to understand what works, for whom and in what contexts, and to ensure that research leads to practical changes in care for the women, babies and families who need them most.”
The launch comes at a pivotal moment for UK maternity care, with growing national attention on improving safety, equity and women’s experiences of care.
The government’s renewed Women’s Health Strategy highlights the need to improve care before and between pregnancies for underserved communities.
Against that backdrop, the consortium will generate the evidence, interventions and research capacity needed to help turn national ambition into practical improvements for women, babies and families.
University of Birmingham is leading work to improve maternity care pathways across the antenatal, intrapartum and postnatal periods.
Antenatal care covers pregnancy before labour, while intrapartum care refers to care during labour and birth.
The consortium will examine how women and families can be better supported before pregnancy and between pregnancies.
This includes improving access to advice and care that can help people prepare for pregnancy, manage existing health conditions and reduce risks before they build up.
Other research will focus on improving care during pregnancy, birth and the early weeks after birth.
This will include work on major causes of poor maternal health, such as high blood pressure, diabetes in pregnancy, obesity, perinatal mental health and complications during recovery after birth.
Professor Judith Rankin OBE, consortium co-lead for research and capacity development at Newcastle University, said: “This funding represents a critical opportunity to make the step change we need to improve outcomes for women and their babies.
“Alongside the research, the Consortium will be investing in tomorrow’s research leaders today to ensure we have the capacity to deliver on improving pregnancy outcomes, access to, and experience of, care.”
The University of Liverpool has secured £1.8m to test a device for postpartum bleeding and launch a new women’s health studio.
The PPH Butterfly is designed to help control postpartum haemorrhage, which is severe bleeding after childbirth and a leading cause of maternal death worldwide.
The funding will support research into how the device can be used in clinical practice and generate evidence to inform its wider adoption.
The university has launched the Women’s Health Innovation Studio, known as the WIN Studio, alongside the project.
The £1.8m initiative is predominantly funded by the National Institute for Health and Care Research, which is providing £1.5m, with additional support from the university.
The PPH Butterfly project will involve a multi-centre clinical trial across the UK and a global feasibility study looking at how practical it would be to use the device in different healthcare settings.
The WIN Studio is led by Andrew Weeks, professor of international maternal health care at the University of Liverpool and a senior investigator at the National Institute for Health and Care Research, and Dr Teesta Dey, a tenure track fellow in the department of women’s and children’s health.
Dr Dey will also lead the PPH Butterfly project.
Its work will cover conditions linked to female biology, including endometriosis, menopause and pregnancy-related complications.
It will also support technologies for diseases that affect women differently or disproportionately, even when they are not usually classed as gender-specific conditions.
Dr Dey said: “Women’s health has often been marginalised within healthcare systems and innovation markets, resulting in treatments, devices and care models that fail to adequately account for women’s specific needs. WIN Studio seeks to change this status quo and reconfigure how health technologies are conceived and delivered.
“The funding from NIHR for this £1.8m project is precisely the kind of innovation the WIN Studio exists to foster: clinically urgent, women-centred, and with the potential to save lives at scale.”
The studio recently hosted an event at Liverpool Women’s University Hospital as part of the Liverpool City Region Combined Authority’s Innovation Investment Fortnight.
Seven innovations are currently undergoing clinical testing through the studio, with three developed internally.
The studio will work closely with NHS University Hospitals Liverpool Group and provide clinical, regulatory and commercial support to people developing women’s health technologies.
It will also involve patients and members of the public in shaping research priorities and product development.
Its wider programme includes collaborations involving clinicians, engineers, economists, academics and policymakers.
The project team says the PPH Butterfly is a simple, low-cost device designed to control severe bleeding quickly and with minimal training.
According to the team, postpartum haemorrhage causes around 70,000 deaths globally each year, equal to about one death every seven minutes.
The device previously received £1.1m in funding from the National Institute for Health and Care Research.
The latest £1.5m grant will support a randomised UK trial, in which participants are allocated to different treatment groups by chance, and a global feasibility assessment.
Weeks said: “In an area where women face deep health inequalities, WIN Studio has a vital role to play. By working in partnership with the NHS, local government and communities, we can ensure that research leads to real-world impact.
“Liverpool has a highly integrated ecosystem of academic, clinical and commercial expertise. By bringing these together under a single platform, the WIN Studio aims to act as a national exemplar for equitable health innovation. Transforming the way medical technologies are developed is essential to addressing gender disparities in healthcare outcomes.”
Another product supported by the university, the LifeStart Trolley, has already reached commercialisation.
The small mobile resuscitation trolley allows newborn care to be carried out at the bedside while the baby’s umbilical cord remains intact, enabling delayed cord clamping.
Delayed cord clamping means waiting before cutting the cord so blood can continue flowing from the placenta to the baby after birth.
Clinical trials conducted around 10 years ago found that life-saving care could be provided successfully at the bedside using the trolley.
It was later commercialised by Inspiration Healthcare and is now used in more than 70 UK maternity units and in 36 countries, including Norway, Italy and the US.
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