Tag: gynaecology

Many Hysterectomies Could be Avoided

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Adenomyosis, a cause of painful menstrual cramps and heavy bleeding, is more common than generally appreciated, and many hysterectomies could be avoided with alternative treatment, suggests a review of the literature published in JAMA Network.

Adenomyosis is a gynaecologic condition characterised by ectopic endometrial tissue within the uterine myometrium. Up to a third of all women have adenomyosis, which should be considered in the differential diagnosis of abnormal uterine bleeding and/or pelvic pain, the researchers noted. It is considered a common uterine condition, but often goes undiagnosed until it results in a hysterectomy.

However, the findings suggest that surgery may be preventable for some women. The researchers identified a range of medical therapies and uterine-sparing procedures that can alleviate symptoms without resorting to hysterectomy.

“Many women come to me and say the only solution they’ve ever been offered is a hysterectomy. Other low-cost, low-risk options such as medical management or less invasive options have existed for more than 20 years,” said lead author Kimberly A Kho, MD.

Modern ultrasound and MRI imaging, combined with a pelvic examination, can often spot the condition, she added. Dr Kho and colleagues encouraged greater awareness of this condition – along with endometriosis – including among school nurses, who are frequently the first contact for young women who begin menstruating. Society may inaccurately teach women that heavy bleeding and pain during periods are normal, but these symptoms can worsen if left untreated, leading to lower quality of life, pain in sexual intercourse, and fertility problems.
“Physicians often consider adenomyosis to be a condition of women in their 40s and 50s because that’s when they have their uteruses removed and receive a diagnosis, but it develops much earlier,” said Dr Kho. “Improved clinical awareness is needed to ensure appropriate patient care and encourage additional studies to improve the understanding of adenomyosis.”

Though there are no FDA-approved therapies specifically indicated for treating adenomyosis, the condition can still be managed by using medications developed for contraception, or for symptoms such as fibroids or endometriosis. The authors noted the need for further research, including what ages and ethnicities are most commonly affected, and what could be learned from the condition about uterine cancers.

Source: UT Southwestern Medical Center

‘Far Too Many Oocytes’ Being Extracted in IVF

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A study has suggested that IVF clinics in the UK may be retrieving “far too many oocytes” and that most of them “may never be used and are probably discarded”, a finding that may well represent global practice.

Studies indicate that the optimal and safe number of oocytes needed for achieving an ongoing pregnancy is between six and 15. However, the use of egg freezing (such as to preserve fertility to a later age, known as social egg freezing), frozen embryo replacement (FER) cycles and aggressive stimulation regimes has raised this number in order to boost success rates in older women and in poor responders who produce fewer eggs. What is not known is the impact of numbers of eggs retrieved and of over-stimulation practices on the health of patients, and on their emotional state and finances.

Details of the analysis were presented online at the virtual Annual Meeting of ESHRE by Dr Gulam Bahadur from North Middlesex University Hospital, London.

More than 1.625 million eggs in the UK were retrieved from 147,274 women between 2015 and 2018. Although an average of 11 eggs was collected per patient, 16% of cycles were associated with 16-49 oocytes retrieved (per cycle) and 58 women each had over 50 eggs collected in a single egg retrieval procedure.

“Our observations suggests that the high oocyte number per retrieval procedure needs re-evaluation,” said Dr Bahadur. “In particular, this needs to focus on the side effects, including ovarian hyperstimulation syndrome and procedure-related complications, and on the fate of unused frozen oocytes and the costs associated with freezing them.

“Patients should be advised that it’s better to collect fewer eggs leading to good quality embryos which may go to term and result in a healthy baby.”

This report is based on all UK IVF clinics and relates to non-donor fertility treatment carried out between 2015 and 2018 during which 172 341 fresh oocyte retrieval cycles took place. All outcomes and patterns remained uniform over the four years.

A substantial number (n = 10 148) of cycles did not yield any oocytes. Over half (53%) of all IVF cycles were in the desired egg yield range of 6-15. In addition, a quarter of cycles yielded 1-5 eggs; 14% produced 16-25; and a minority (2%) resulted in 26-49 oocytes. The authors point out that multiple birth rates increase significantly from 6-15 oocytes onwards, which increases the risk of birth complications and low birth weight.

A total of 931 265 embryos resulted from all eggs retrieved – a fertilisation rate of 57%. Of the embryos created, more than one in five (22% or 209,080) were transferred into the uterus, while a slightly higher proportion (24% or 219, 563) were frozen.

The fate of the unfertilised oocytes (43%) is unknown, though they are usually discarded. Most of the embryos not transferred (54%) will likely be discarded after patients have paid for several years of storage.

“This comes with a financial and emotional cost,” said Bahadur. “Patients build an attachment with this frozen material and there’s insufficient counselling to support them. They should be given more information about the implications of freezing eggs and embryos.”

Source: European Society of Human Reproduction and Embryology

Beneficial Microbiota can be Restored at Birth in C-section Babies

Photo by Christian Bowen on Unsplash

Babies born by caesarean section lack the same healthy bacteria as those born vaginally, but a Rutgers-led study for the first time finds that these natural bacteria can be restored.

The human microbiota, consisting of trillions of bacteria, viruses, fungi and other microorganisms, live in and on our bodies, some potentially harmful while others provide benefits. During labour and birth, women naturally impart a small group of colonisers to their babies’ sterile bodies, which helps their immune system to develop. But antibiotics and C-sections disrupt this conferring of microbes and are related to increased risks of obesity (59% increase), asthma (21% increase) and metabolic diseases. ‘Vaginal seeding‘, where a baby delivered by C-section is swabbed with their mother’s vaginal fluids at birth, is becoming increasingly popular.

According to the World Health Organization, C-section is needed in about 15 percent of births to avoid risking the life of the mother or child. However, caesarean birth rates continue to rise worldwide with recent (2016) reported rates of 24.5% in Western Europe, 32% in North America, and 41% in South America.

To see how well babies could be seeded with the mother’s microbiota after birth, the researchers followed 177 babies from four countries over the first year of their lives. Of these, 98 were born vaginally and 79 were born by C-section, 30 of which were swabbed with a maternal vaginal gauze right after birth.

Analysis showed that the microbiota of the C-section babies swabbed with their mother’s vaginal fluids was similar to that of vaginally born babies. Also, the mother’s vaginal microbiomes on the day of birth were similar to other areas of their bodies (gut, mouth and skin), indicating that maternal vaginal fluids help to colonise bacteria across their babies’ bodies.

This was the first large observational study to show that ‘vaginal seeding’ normalises the microbiome development during their first year of life. The next step would be conducting randomised clinical trials to determine if the microbiota normalisation translates into disease protection, the researchers said.

“Further research is needed to determine which bacteria protect against obesity, asthma and allergies, diseases with underlying inflammation,” said senior author Maria Gloria Dominguez Bello, a professor in the Department of Biochemistry and Microbiology in the School of Environmental and Biological Sciences at Rutgers University-New Brunswick. “Our results support the hypothesis that acquiring maternal vaginal microbes normalises microbiome development in the babies.”

Source: University News

Epidurals Do Not Increase Autism Risk for Babies

A Canadian study showed that children born to mothers who used epidural analgesia during labour were not at increased risk of developing autism spectrum disorder (ASD).

Epidural analgesia is administered into the epidural space around the spinal cord, typically during labour. Besides easing pain and reducing the use of other analgesics, it has also been shown to lower cortisol levels, expedite the return of bowel function, decrease the incidence of PE and DVT in the postoperative period, and reduce hospital stays.

Epidural analgesia is used by 73% of pregnant women in the U.S. for pain during labour. Since the US incidence of ASD increased from 0.66% in 2002 to 1.85% in 2016, there have been more efforts to identify environmental factors that put children at risk, the researchers said.

Elizabeth Wall-Wieler, PhD, of the University of Manitoba in Winnipeg, and colleagues drew from population datasets and included vaginal deliveries of singleton babies born in Canada from 2005 to 2016, following children from birth up until 2019.

Of the more than 123 000 infants included in the study, approximately 38% were exposed to epidural analgesia during delivery, and about 80 000 had a sibling in the study cohort. The mean age of mothers was 28 years. The children’s median age at their first diagnosis of ASD was 4 years. Births with epidural analgesia were more likely to be nulliparous or involve other factors such as foetal distress.
About 2.1% of children exposed to epidural labour analgesia (ELA) later developed ASD, compared with 1.7% who were not exposed, the team reported. But after factor adjustments, the researchers found no association between epidural analgesia and childhood ASD risk, they wrote in JAMA Pediatrics.

“This finding is of clinical importance in the context of pregnant women and their obstetric and anesthesia care professionals who are considering ELA during labor,” Dr Wall-Wieler and colleagues noted.

The group’s results contrast with Qiu et al.’s recent study that found a 37% increased risk of autism in children whose mothers used epidural analgesia during their delivery. Their study did not account for key perinatal factors, such as induction of labor, labor dystocia, and foetal distress, and drew criticism from five medical societies for possible residual confounding.

Dr Wall-Wieler and colleagues said that ELA is “recognized as the most effective method of providing labor analgesia,” adding that future qualitative research should assess how their findings — as well as the prior ones — have altered the perceptions about the perceived risk of ASD in offspring among both pregnant women and healthcare providers.

In an accompanying editorial, Gillian Hanley, PhD, of the University of British Columbia in Vancouver, and colleagues said that given the concerns stemming from previous findings, “it thus comes with some relief that Wall-Wieler et al found no association when controlling for key maternal sociodemographic and perinatal factors.”

“Epidural labor analgesia is an extremely effective approach to obstetric analgesia,” Dr Hanley’s group noted. “We have a collective responsibility to understand whether it is a safe option that sets a healthy developmental pathway well into childhood.”

The researchers observed an association between ELA and autism risk before accounting for confounders; but after controlling for all maternal sociodemographic, pre-pregnancy, pregnancy and perinatal factors, there was no longer a correlation.

In an analysis of siblings, researchers again observed a null association after controlling for all confounders and family fixed effects. Siblings who were exposed to epidural analgesia had a 2% cumulative risk of developing autism, and unexposed siblings had a risk of 1.6%.

The accuracy of inpatient and outpatient diagnostic codes for ASD, as well as coding for ELA was acknowledged as a study limitation by the researchers, as well as a lack of data describing epidural analgesia drug doses.

Source: MedPage Today

Journal information: Wall-Wieler E, et al “Association of epidural labor analgesia with offspring risk of autism spectrum disorders” JAMA Pediatr 2021; DOI: 10.1001/jamapediatrics.2021.0376.

Relugolix Combination Therapy is Promising for Fibroid Symptom Relief

A pair of clinical trials showed that combination therapy with relugolix reduced heavy bleeding and pain from uterine fibroids without the risk of side effects from low oestrogen levels.

Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, currently approved for men with advanced prostate cancer.  Uterine fibroids are common in women, and a quarter of those who are affected by them experience symptoms such as heavy menstrual bleeding and pain.

Injectable long-acting GnRH agonists are effective treatments for uterine fibroids, but cause BMD loss and thus are not generally eligible for long term use.  
In the two trials done in North and South America, Africa, and Europe, 71% and 73% of patients, respectively, who received relugolix together with estradiol and norethindrone acetate had significantly lower blood loss, compared with 19% and 15% in the placebo group.
Similar bone mineral density (BMD) measures were seen in the placebo and relugolix combination therapy groups; but MD decreased among patients who received relugolix monotherapy.

“For the first time, we have an oral treatment that can effectively and safely improve the symptoms of uterine fibroids, particularly heavy menstrual bleeding,” Ayman Al-Hendy, MD, PhD, of the University of Chicago Medicine, stated in an interview. and added that relugolix may be a viable, long-term alternative to the current surgical treatments available for fibroids patients.

“The goal of this program from the beginning was to develop an effective and long-term treatment as a viable alternative to hysterectomy,” Dr Al-Hendy said. “Any patient with uterine fibroids would be a good candidate for this non-surgical treatment.”

Lauren Schiff, MD, associate professor of minimally invasive gynecologic surgery at the school of medicine at the University of North Carolina at Chapel Hill, said that relugolix seems to be a good option for non-surgical treatment of fibroids.

Dr Schiff, who was not involved with the study, said that understanding bone mineral density (BMD) is key for using relugolix past six months. “If the bone density safety measure is maintained for long-term use, then this would be really ideal medication,” she told MedPage Today.

The trial’s primary endpoint was less than 80 ml blood loss, and >50% reduction in total blood loss from trial start. The investigators assessed several secondary outcomes, including amenorrhea, volume of menstrual blood loss, distress, pain, anaemia, fibroid volume, and uterine volume.

Around 388 participants were randomised in the first trial, and 382 in the second.

Around three-quarters of patients who received relugolix combination therapy reached the primary endpoint, with the treatment effects appearing similar baseline characteristics.

Amenorrhea over the last 35 days of the trial occurred in 52% and 50% of participants who received relugolix combination therapy in each trial, respectively. Pain was also reduced in the treatment groups.

Patients who received the combination therapy also had improvements in pain, distress from bleeding and pelvic discomfort, anaemia, and experienced reduced uterine volume. However, significant shrinkage in fibroid volume was not observed.

The prevalence of side effects was similar in the relugolix combination therapy group and the placebo cohort, with hot flashes being the most commonly reported side effect in the trial.

Strict assessment criteria for patients meant generalisability was limited. Additionally, study duration was only six months. The researchers plan to release data from a 28-week extension study, as well as a 52-week randomised-withdrawal trial, and these may shed more light on safety and efficacy in the long term.

Source: MedPage Today

Journal information: Al-Hendy A, et al “Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy” N Engl Med 2021; DOI: 10.1056/NEJMoa2008283.