Clarifying the unmet clinical need during medical device innovation in women's health - A narrative review.

Medical technologies are pervasive across women's health, spanning across obstetric and gynecological care. FemTech, the sector responsible for developing these technologies, is growing at 15.6% per annum. However, there are concerns of disconnects between new product development (NPD) and the care afforded to women in consequence of implementing these innovations. The most crucial stage of NPD involves understanding the clinical need. Without a clear need and clinical use case, innovators risk developing solutions which do not address the issues women and caregivers experience. Thus, the product will miss the market and experience limited uptake. Tools for performing clinical needs assessments and defining the use case are being developed. This review provides an analysis of their strengths and weaknesses to inform FemTech innovators of the available resources. We further discuss concepts for creating a unified approach to assessing unmet needs such that technologies have a higher chance of improving women's healthcare.

Time to diagnosis of Duchenne muscular dystrophy remains unchanged: Findings from the Muscular Dystrophy Surveillance, Tracking, and Research Network, 2000-2015.

INTRODUCTION/AIMS: With current and anticipated disease-modifying treatments, including gene therapy, an early diagnosis for Duchenne muscular dystrophy (DMD) is crucial to assure maximum benefit. In 2009, a study from the Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) showed an average diagnosis age of 5 years among males with DMD born from January 1, 1982 to December 31, 2000. Initiatives were implemented by the US Centers for Disease Control and Prevention (CDC) and patient organizations to reduce time to diagnosis. We conducted a follow-up study in a surveillance cohort born after January 1, 2000 to determine whether there has been an improvement in time to diagnosis. METHODS: We assessed the age of diagnosis among males with DMD born from January 1, 2000 to December 31, 2015 using data collected by six US MD STARnet surveillance sites (Colorado, Iowa, western New York State, the Piedmont region of North Carolina, South Carolina, and Utah). The analytic cohort included 221 males with definite or probable DMD diagnosis without a documented family history. We computed frequency count and percentage for categorical variables, and mean, median, and standard deviation (SD) for continuous variables. RESULTS: The mean [median] ages in years of diagnostic milestones were: first signs, 2.7 [2.0]; first creatine kinase (CK), 4.6 [4.6]; DNA/muscle biopsy testing, 4.9 [4.8]; and time from first signs to diagnostic confirmation, 2.2 [1.4]. DISCUSSION: The time interval between first signs of DMD and diagnosis remains unchanged at 2.2 years. This results in lost opportunities for timely genetic counseling, implementation of standards of care, initiation of glucocorticoids, and participation in clinical trials.

The effect of Ebola virus disease on maternal health service utilisation and perinatal outcomes in West Africa: a systematic review.

BACKGROUND: Ebola outbreaks pose a major threat to global public health, especially in Sub-Saharan Africa. These outbreaks disrupt the already fragile maternal health services in West Africa. The aims of this study is to assess the effect of Ebola virus disease (EVD) on maternal health service utilisation and perinatal outcomes. METHODS: This systematic review was conducted in West Africa, and the databases used were Medline, PubMed, CINAHL, Scopus, EMBASE and African journals online. Studies that reported the effect of the Ebola outbreak on maternal health services in West Africa were eligible for this systematic review. The search was limited to articles written in the English language only and published between 2013 and 2020. Three authors independently appraised the articles, and the data were extracted using a standardised data extraction format. The findings were synthesised using a narrative summary, tables, and figures. RESULTS: Twelve studies met the inclusion criteria and were used for this systematic review synthesis. The results showed that antenatal care significantly decreased during Ebola virus disease and strove to recover post-Ebola virus disease. Women were less likely to have institutional childbirth during Ebola virus disease and struggled to recover post-Ebola virus disease. In addition, this review revealed a substantially higher rate of maternal mortality post EVD than those observed before or during the outbreak. CONCLUSION: Based on our findings, antenatal care, institutional childbirth, and postnatal care are attempting to recover post-Ebola virus disease. We recommended that responsible bodies and stakeholders need to prepare locally tailored interventions to increase the number of women attending ANC, institutional childbirth, and PNC services post-EVD and future outbreaks including COVID-19. In order to build trust, creating community networks between health care providers and trusted community leaders may increase the number of women attending antenatal care (ANC), institutional childbirth and postnatal care (PNC) post-EVD and during future outbreaks. Further studies are needed to examine health centre and hospital availability and accessibility, and capacity to deliver maternal health services post-Ebola virus disease and future outbreaks.

Ebola virus disease (EVD) is a serious public health concern affecting the health of humans and other primates. These outbreaks disrupt the already fragile maternal health services in West Africa. There is limited data on the effect of EVD on maternal health service utilisation and perinatal outcomes in West Africa. This systematic review aims to synthesise evidence on maternal health service utilisation and perinatal outcomes before EVD, during EVD and post EVD.This systematic review was conducted in West Africa, and the databases used were Medline, PubMed, CINAHL, Scopus, EMBASE and African journals online. Twelve studies met the inclusion criteria and were used for this systematic review synthesis. The results showed that antenatal care significantly decreased during the Ebola virus outbreak and strove to recover post-Ebola virus disease. This finding indicated that women were less likely to have an institutional birth during EVD and struggled to recover post-Ebola virus disease. Based on this finding, responsible bodies and stakeholders need to prepare locally tailored interventions to increase the number of women attending ANC, institutional childbirth, and PNC services post-EVD and future outbreaks.

Association of genetic mutations and loss of ambulation in childhood-onset dystrophinopathy.

BACKGROUND: Quantifying associations between genetic mutations and loss of ambulation (LoA) among males diagnosed with childhood-onset dystrophinopathy is important for understanding variation in disease progression and may be useful in clinical trial design. METHODS: Genetic and clinical data from the Muscular Dystrophy Surveillance, Tracking, and Research Network for 358 males born and diagnosed from 1982 to 2011 were analyzed. LoA was defined as the age at which independent ambulation ceased. Genetic mutations were defined by overall type (deletion/duplication/point mutation) and among deletions, those amenable to exon-skipping therapy (exons 8, 20, 44-46, 51-53) and another group. Cox proportional hazards regression modeling was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: Mutation type did not predict time to LoA. Controlling for corticosteroids, Exons 8 (HR = 0.22; 95% CI = 0.08, 0.63) and 44 (HR = 0.30; 95% CI = 0.12, 0.78) were associated with delayed LoA compared to other exon deletions. CONCLUSIONS: Delayed LoA in males with mutations amenable to exon-skipping therapy is consistent with previous studies. These findings suggest that clinical trials including exon 8 and 44 skippable males should consider mutation information prior to randomization.

Population-Based Surveillance for Birth Defects Potentially Related to Zika Virus Infection - 22 States and Territories, January 2016-June 2017.

Zika virus infection during pregnancy can cause congenital brain and eye abnormalities and is associated with neurodevelopmental abnormalities (1-3). In areas of the United States that experienced local Zika virus transmission, the prevalence of birth defects potentially related to Zika virus infection during pregnancy increased in the second half of 2016 compared with the first half (4). To update the previous report, CDC analyzed population-based surveillance data from 22 states and territories to estimate the prevalence of birth defects potentially related to Zika virus infection, regardless of laboratory evidence of or exposure to Zika virus, among pregnancies completed during January 1, 2016-June 30, 2017. Jurisdictions were categorized as those 1) with widespread local transmission of Zika virus; 2) with limited local transmission of Zika virus; and 3) without local transmission of Zika virus. Among 2,004,630 live births, 3,359 infants and fetuses with birth defects potentially related to Zika virus infection during pregnancy were identified (1.7 per 1,000 live births, 95% confidence interval [CI] = 1.6-1.7). In areas with widespread local Zika virus transmission, the prevalence of birth defects potentially related to Zika virus infection during pregnancy was significantly higher during the quarters comprising July 2016-March 2017 (July-September 2016 = 3.0; October-December 2016 = 4.0; and January-March 2017 = 5.6 per 1,000 live births) compared with the reference period (January-March 2016) (1.3 per 1,000). These findings suggest a fourfold increase (prevalence ratio [PR] = 4.1, 95% CI = 2.1-8.4) in birth defects potentially related to Zika virus in widespread local transmission areas during January-March 2017 compared with that during January-March 2016, with the highest prevalence (7.0 per 1,000 live births) in February 2017. Population-based birth defects surveillance is critical for identifying infants and fetuses with birth defects potentially related to Zika virus regardless of whether Zika virus testing was conducted, especially given the high prevalence of asymptomatic disease. These data can be used to inform follow-up care and services as well as strengthen surveillance.

Gastroschisis Trends and Ecologic Link to Opioid Prescription Rates - United States, 2006-2015.

Prevalence of gastroschisis, a serious birth defect of the abdominal wall resulting in some of the abdominal contents extending outside the body at birth, has been increasing worldwide (1,2). Gastroschisis requires surgical repair after birth and is associated with digestive and feeding complications during infancy, which can affect development. Recent data from 14 U.S. states indicated an increasing prevalence of gastroschisis from 1995 to 2012 (1). Young maternal age has been strongly associated with gastroschisis, but research suggests that risk factors such as smoking, genitourinary infections, and prescription opioid use also might be associated (3-5). Data from 20 population-based state surveillance programs were pooled and analyzed to assess age-specific gastroschisis prevalence during two 5-year periods, 2006-2010 and 2011-2015, and an ecologic approach was used to compare annual gastroschisis prevalence by annual opioid prescription rate categories. Gastroschisis prevalence increased only slightly (10%) from 2006-2010 to 2011-2015 (prevalence ratio = 1.1, 95% confidence interval [CI] = 1.0-1.1), with the highest prevalence among mothers aged <20 years. During 2006-2015, the prevalence of gastroschisis was 1.6 times higher in counties with high opioid prescription rates (5.1 per 10,000 live births; CI = 4.9-5.3) and 1.4 times higher where opioid prescription rates were medium (4.6 per 10,000 live births; CI = 4.4-4.8) compared with areas with low prescription rates (3.2 per 10,000 live births; CI = 3.1-3.4). Public health research is needed to understand factors contributing to the association between young maternal age and gastroschisis and assess the effect of prescription opioid use during pregnancy on this pregnancy outcome.

Health profile of a cohort of adults with Duchenne muscular dystrophy.

INTRODUCTION: As the Duchenne muscular dystrophy (DMD) population ages, it is essential that we understand the late-stage health profile and provide the appropriate care for this emerging population. METHODS: We undertook a descriptive study to document the health profile of a cohort of adults with DMD using data from the Muscular Dystrophy Surveillance Tracking and Research network (MD STARnet). Data included information collected from Arizona, Colorado, Iowa, Georgia, and 12 counties in western New York on individuals born since January 1982 and followed through December 2012. RESULTS: In 208 adults with DMD, the number of individuals (N) and median ages (years) at which certain critical milestones were crossed and interventions initiated were as follows: development of cardiomyopathy, N = 145 (16.7); initiation of non-invasive ventilation, N = 99 (18.0); gastrostomy, N = 47 (19.0); and death, N = 59 (21.8). DISCUSSION: These population-based data provide critical information about late-stage health profiles among adults with DMD for developing appropriate models of care. Muscle Nerve 58: 219-223, 2018.

Population-Based Surveillance of Birth Defects Potentially Related to Zika Virus Infection - 15 States and U.S. Territories, 2016.

Zika virus infection during pregnancy can cause serious birth defects, including microcephaly and brain abnormalities (1). Population-based birth defects surveillance systems are critical to monitor all infants and fetuses with birth defects potentially related to Zika virus infection, regardless of known exposure or laboratory evidence of Zika virus infection during pregnancy. CDC analyzed data from 15 U.S. jurisdictions conducting population-based surveillance for birth defects potentially related to Zika virus infection.* Jurisdictions were stratified into the following three groups: those with 1) documented local transmission of Zika virus during 2016; 2) one or more cases of confirmed, symptomatic, travel-associated Zika virus disease reported to CDC per 100,000 residents; and 3) less than one case of confirmed, symptomatic, travel-associated Zika virus disease reported to CDC per 100,000 residents. A total of 2,962 infants and fetuses (3.0 per 1,000 live births; 95% confidence interval [CI] = 2.9-3.2) (2) met the case definition.† In areas with local transmission there was a non-statistically significant increase in total birth defects potentially related to Zika virus infection from 2.8 cases per 1,000 live births in the first half of 2016 to 3.0 cases in the second half (p = 0.10). However, when neural tube defects and other early brain malformations (NTDs)§ were excluded, the prevalence of birth defects strongly linked to congenital Zika virus infection increased significantly, from 2.0 cases per 1,000 live births in the first half of 2016 to 2.4 cases in the second half, an increase of 29 more cases than expected (p = 0.009). These findings underscore the importance of surveillance for birth defects potentially related to Zika virus infection and the need for continued monitoring in areas at risk for Zika.

Prevalence and Clinical Attributes of Congenital Microcephaly - New York, 2013-2015.

Congenital Zika virus infection can cause microcephaly and other severe fetal neurological anomalies (1). To inform microcephaly surveillance efforts and assess ascertainment sources, the New York State Department of Health and the New York City Department of Health and Mental Hygiene sought to determine the prevalence of microcephaly in New York during 2013-2015, before known importation of Zika virus infections. Suspected newborn microcephaly diagnoses were identified from 1) reports submitted by birth hospitals in response to a request and 2) queries of a hospital administrative discharge database for newborn microcephaly diagnoses. Anthropometric measurements, maternal demographics, and pregnancy characteristics were abstracted from newborn records from both sources. Diagnoses were classified using microcephaly case definitions developed by CDC and the National Birth Defects Prevention Network (NBDPN) (2). During 2013-2015, 284 newborns in New York met the case definition for severe congenital microcephaly (prevalence = 4.2 per 10,000 live births). Most newborns with severe congenital microcephaly were identified by both sources; 263 (93%) were identified through hospital requests and 256 (90%) were identified through administrative discharge data. The proportions of newborns with severe congenital microcephaly who were black (30%) or Hispanic (31%) were higher than the observed proportions of black (15%) or Hispanic (23%) infants among New York live births. Fifty-eight percent of newborns with severe congenital microcephaly were born to mothers with pregnancy complications or who had in utero or perinatal infections or teratogenic exposures, genetic disorders, or family histories of birth defects.

Population-based microcephaly surveillance in the United States, 2009 to 2013: An analysis of potential sources of variation.

BACKGROUND: Congenital microcephaly has been linked to maternal Zika virus infection. However, ascertaining infants diagnosed with microcephaly can be challenging. METHODS: Thirty birth defects surveillance programs provided data on infants diagnosed with microcephaly born 2009 to 2013. The pooled prevalence of microcephaly per 10,000 live births was estimated overall and by maternal/infant characteristics. Variation in prevalence was examined across case finding methods. Nine programs provided data on head circumference and conditions potentially contributing to microcephaly. RESULTS: The pooled prevalence of microcephaly was 8.7 per 10,000 live births. Median prevalence (per 10,000 live births) was similar among programs using active (6.7) and passive (6.6) methods; the interdecile range of prevalence estimates was wider among programs using passive methods for all race/ethnicity categories except Hispanic. Prevalence (per 10,000 live births) was lowest among non-Hispanic Whites (6.5) and highest among non-Hispanic Blacks and Hispanics (11.2 and 11.9, respectively); estimates followed a U-shaped distribution by maternal age with the highest prevalence among mothers <20 years (11.5) and ≥40 years (13.2). For gestational age and birth weight, the highest prevalence was among infants <32 weeks gestation and infants <1500 gm. Case definitions varied; 41.8% of cases had an HC ≥ the 10th percentile for sex and gestational age. CONCLUSION: Differences in methods, population distribution of maternal/infant characteristics, and case definitions for microcephaly can contribute to the wide range of observed prevalence estimates across individual birth defects surveillance programs. Addressing these factors in the setting of Zika virus infection can improve the quality of prevalence estimates. Birth Defects Research (Part A) 106:972-982, 2016. © 2016 Wiley Periodicals, Inc.

Fetal alcohol syndrome among children aged 7-9 years - Arizona, Colorado, and New York, 2010.

Fetal alcohol syndrome (FAS) is a serious birth defect and developmental disorder caused by in utero exposure to alcohol. Assessment of the public health burden of FAS through surveillance has proven difficult; there is wide variation in reported prevalence depending on the study population and surveillance method. Generally, records-based birth prevalence studies report estimates of 0.2-1.5 per 1,000 live births, whereas studies that use in-person, expert assessment of school-aged children in a community report estimates of 6-9 per 1,000 population. The Fetal Alcohol Syndrome Surveillance Network II addressed some of the challenges in records-based ascertainment by assessing a period prevalence of FAS among children aged 7‒9 years in Arizona, Colorado, and New York. The prevalence across sites ranged from 0.3 to 0.8 per 1,000 children. Prevalence of FAS was highest among American Indian/Alaska Native children and lowest among Hispanic children. These estimates continue to be much lower than those obtained from studies using in-person, expert assessment. Factors that might contribute to this discrepancy include 1) inadequate recognition of the physical and behavioral characteristics of FAS by clinical care providers; 2) insufficient documentation of those characteristics in the medical record; and 3) failure to consider prenatal alcohol exposure with diagnoses of behavioral and learning problems. Addressing these factors through training of medical and allied health providers can lead to practice changes, ultimately increasing recognition and documentation of the characteristics of FAS.

Methods for surveillance of fetal alcohol syndrome: The Fetal Alcohol Syndrome Surveillance Network II (FASSNetII) - Arizona, Colorado, New York, 2009 - 2014.

Surveillance of fetal alcohol syndrome (FAS) is important for monitoring the effects of prenatal alcohol exposure and describing the public health burden of this preventable disorder. Building on the infrastructure of the Fetal Alcohol Syndrome Surveillance Network (FASSNet, 1997-2002), in 2009 the Centers for Disease Control and Prevention awarded 5-year cooperative agreements to three states, Arizona, Colorado, and New York, to conduct population-based surveillance of FAS. The Fetal Alcohol Syndrome Surveillance Network II (FASSNetII, 2009-2014) developed a surveillance case definition based on three clinical criteria: characteristic facial features, central nervous system abnormalities, and growth deficiency. FASSNetII modified the FASSNet methods in three important ways: (1) estimation of a period prevalence rather than birth prevalence; (2) surveillance of FAS among school-age children (ages 7-9 years) to better document the central nervous system abnormalities that are not apparent at birth or during infancy; and (3) implementation of an expert clinical review of abstracted data for probable and confirmed cases classified through a computerized algorithm. FASSNetII abstracted data from multiple sources including birth records, medical records from child development centers or other specialty clinics, and administrative databases such as hospital discharge and Medicaid. One challenge of FASSNetII was its limited access to non-medical records. The FAS prevalence that could be estimated was that of the population identified through an encounter with the healthcare system. Clinical and public health programs that identify children affected by FAS provide critical information for targeting preventive, medical and educational services in this vulnerable population.

Sibling concordance for clinical features of Duchenne and Becker muscular dystrophies.

INTRODUCTION: The correlation of markers of disease severity among brothers with Duchenne or Becker muscular dystrophy has implications for clinical guidance and clinical trials. METHODS: Sibling pairs with Duchenne or Becker muscular dystrophy (n = 60) were compared for ages when they reached clinical milestones of disease progression, including ceased ambulation, scoliosis of ≥ 20°, and development of cardiomyopathy. RESULTS: The median age at which younger brothers reached each milestone, compared with their older brothers ranged from 25 months younger for development of cardiomyopathy to 2 months older for ceased ambulation. For each additional month of ambulation by the older brother, the hazard of ceased ambulation by the younger brother decreased by 4%. CONCLUSIONS: The ages when siblings reach clinical milestones of disease vary widely between siblings. However, the time to ceased ambulation for older brothers predicts the time to ceased ambulation for their younger brothers.

Exploring the feasibility of using electronic health records in the surveillance of fetal alcohol syndrome.

BACKGROUND: Explore the use of electronic health records (EHRs) in fetal alcohol syndrome (FAS) surveillance systems. METHODS: Using EHRs we identified diagnoses and anthropometric measurements related to the FAS criteria developed by the Fetal Alcohol Syndrome Surveillance Network (FASSNet) among children aged 0 to 12 years. RESULTS: There were 143,393 distinct children aged between 0 and 12 years enrolled in Kaiser Permanente, Georgia, during the study period. Based on diagnoses and anthropometric measurements, 20,101 children met at least one criterion of interest, and when grouped into combinations of different criteria there were 2285 who met GROWTH+CNS criteria, 76 children who met GROWTH+FACE criteria, 107 children who met CNS+FACE criteria, and 93 children who met GROWTH+CNS+FACE criteria. The prevalence of FAS as defined by FASSNet is 1.92 per 1000 children. We linked 17,084 (85.0%) children to their mothers in the health plan; only 3% of mothers of children in the GROWTH+CNS+FACE group had an indication of alcohol or drugs use, but they had the highest rate of depression (39%). CONCLUSION: Data of utility in identification of FAS are readily available in EHRs and may serve as a basis for intervention with at-risk children and in planning of future FAS surveillance programs.

Impact of COVID-19 on antenatal care provision at public hospitals in the Sidama region, Ethiopia: A mixed methods study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) continues to pose a global public health threat. The pandemic overstretched already weak health systems in low- and low-middle-income countries, including Ethiopia. There is a paucity of studies on the impact of COVID-19 on antenatal care access, uptake, and provision in Ethiopia. This study examines the impact of COVID-19 on antenatal care provision in the Sidama region, Ethiopia. METHODS: A concurrent mixed-methods study was conducted between 14 February and 10 May 2022 at 15 public hospitals in the Sidama region. An interrupted times series design was applied for a quantitative study, which included data from all pregnant women who attended antenatal care before COVID-19 (12 months, March 2019 to February 2020) and during COVID-19 (six months, March to August 2020) at 15 public hospitals in the region. The total numbers in the antenatal care 1 cohort (at least one antenatal care contact) and antenatal care 4 cohort (at least four antenatal care contacts) were 15,150 and 5,850, respectively, forming a combined final dataset of 21,000 women. Routinely collected monthly data were derived from the hospitals' health management information system and imported into Stata version 17 for analysis. The mean monthly incidence rate ratio of antenatal care uptake was calculated using a Poisson regression model with a 95% confidence interval. Simultaneously, an exploratory study design was conducted for qualitative using in-depth interviews to explore maternity care providers' perceptions of the impact of COVID-19 on antenatal care access, uptake, and provision. Qualitative data were thematically analysed. The quantitative and qualitative findings were then integrated using the joint display technique. RESULTS: Our findings indicate a significant monthly decrease of 0.7% in antenatal care 1 and 1.8% in antenatal care 4 during the first six months of the pandemic. A lack of medical supplies, fear of contracting COVID-19, inadequate personal protective equipment, discrimination against those attending the hospital, and the absence of antenatal care guidelines for care provision, COVID-19 vaccine hesitancy and long waiting times for ANC led to disrupted access, uptake, and provision of antenatal care during COVID-19. CONCLUSION AND RECOMMENDATIONS: Our findings demonstrate that the COVID-19 pandemic affected antenatal care access, uptake, and provision in the study area from March to August 2020. To mitigate disrupted antenatal care access, uptake and provision, antenatal care clinics should be equipped with medical supplies. It is crucial to maintain rapport between the community and maternity care providers and provide training for maternity care providers regarding the adapted/adopted guidelines during COVID-19 at the hospital grassroots level for use in the current and future pandemics. Pregnant women should have timely access to maternity care providers in order to maintain at least a minimum standard of care in current and future pandemics.

How does the use of continuous electronic fetal monitoring influence women's experiences of labour? A systematic integrative review of the literature from high income countries.

BACKGROUND: A variety of technologies are used to monitor fetal wellbeing in labour. Different types of fetal monitoring devices impact women's experiences of labour and birth. AIM: This review aims to understand how continuous electronic fetal monitoring (CEFM) influences women's experiences, with a focus on sense of control, active decision-making and mobility. METHODS: A systematic search of the literature was conducted. Findings from qualitative, quantitative and mixed methods studies were analysed to provide a review of current evidence. FINDINGS: Eighteen publications were included. The findings were synthesised into three themes: 'Feeling reassured versus anxious about the welfare of their baby', 'Feeling comfortable and free to be mobile versus feeling uncomfortable and restricted', and 'Feeling respected and empowered to make decisions versus feeling depersonalised with minimal control '. Women experienced discomfort and a lack of mobility as a result of some CEFM technologies. They often felt anxious and had mixed feelings about their baby's welfare whilst these were in use. Some women valued the data produced by CEFM technologies about the welfare of their baby. Many women experienced a sense of depersonalisation and lack of control whilst CEFM technologies were used. DISCUSSION: Fetal monitoring technologies influence women's experiences of labour both positively and negatively. Wireless devices were associated with the most positive response as they enabled greater freedom of movement. CONCLUSION: The design of emerging fetal monitoring technologies should incorporate elements which foster freedom of movement, are comfortable and provide women with a sense of choice and control. The implementation of fetal monitoring that enables these elements should be prioritised by health professionals.

Exploring the feasibility of conducting a randomised controlled trial of group-based pregnancy care and education: a pilot randomised controlled trial in Melbourne, Australia.

BACKGROUND: In group-based pregnancy models, antenatal care and childbirth/parenting education are provided in groups of eight to 10 women, usually with two midwives, and six to eight sessions. Current evidence is inconclusive regarding potential benefit or harm. We aimed to explore the feasibility of implementing an adequately powered randomised controlled trial (RCT). METHODS: A two-arm pilot RCT was conducted in a tertiary maternity hospital in Melbourne, Australia. Women were randomly allocated to either the intervention to receive group-based antenatal care and education (group care) or to usual care, which included hospital-based midwife, caseload midwifery, team midwifery, or GP shared care. Participants were English-speaking, primiparous, low risk, and < 24 weeks gestation at booking. DATA COLLECTION: feasibility measures throughout pilot, baseline questionnaire at recruitment, clinical outcome data from the medical record, and a telephone-administered questionnaire 6 weeks postpartum. A focus group explored midwives' views. RESULTS: Seventy-four women were recruited from May to June 2017 (group care = 40, usual care = 34). Study uptake was 35%. Women allocated to group care rated their overall pregnancy care more highly (88% good/very good vs 77% in usual care). There was no evidence of harm related to group care. Overarching themes from the midwives were that group care helped 'build connections' and 'empower women'. All midwives would work in the model again and believed it should be expanded. CONCLUSION: Group care was acceptable to both women and midwives with no evidence of harm. The pilot demonstrated the feasibility of undertaking a large adequately powered RCT, important given the inconclusive evidence on clinical outcomes regarding the model, and its current relatively widespread implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000858695.

Tending to the machine: The impact of intrapartum fetal surveillance on women in Australia.

Qualitative research about women and birthing people's experiences of fetal monitoring during labour and birth is scant. Labour and birth is often impacted by wearable or invasive monitoring devices, however, most published research about fetal monitoring is focused on the wellbeing of the fetus. This manuscript is derived from a larger mixed methods study, 'WOmen's Experiences of Monitoring Baby (The WOMB Study)', aiming to increase understanding of the experiences of women and birthing people in Australia, of being monitored; and about the information they received about fetal monitoring devices during pregnancy. We constructed a national cross-sectional survey that was distributed via social media in May and June, 2022. Responses were received from 861 participants. As far as we are aware, this is the first survey of the experiences of women and birthing people of intrapartum fetal monitoring conducted in Australia. This paper comprises the analysis of the free text survey responses, using qualitative and inductive content analysis. Two categories were constructed, Tending to the machine, which explores participants' perceptions of the way in which clinicians interacted with fetal monitoring technologies; and Impressions of the machine, which explores the direct impact of fetal monitoring devices upon the labour and birth experience of women and birthing people. The findings suggest that some clinicians need to reflect upon the information they provide to women and birthing people about monitoring. For example, freedom of movement is an important aspect of supporting the physiology of labour and managing pain. If freedom of movement is important, the physical restriction created by a wired cardiotocograph is inappropriate. Many participants noticed that clinicians focused their attention primarily on the technology. Prioritising the individual needs of the woman or birthing person is key to providing high quality woman-centred intrapartum care. Women should be provided with adequate information regarding the risks and benefits of different forms of fetal monitoring including how the form of monitoring might impact her labour experience.

Reproductive patterns among mothers of males diagnosed with Duchenne or Becker muscular dystrophy.

Diagnosis of a child with Duchenne or Becker muscular dystrophy (DBMD) may impact future maternal reproductive choice; however, little is known about the reproductive patterns of mothers with a male child diagnosed with DBMD. Using population-based surveillance data collected by the muscular dystrophy surveillance, tracking, and research network, the proportion of mothers who conceived and delivered a live birth following the diagnosis of DBMD in an affected male child and factors associated with such reproductive choice were identified. To accomplish this, maternal demographic data were linked to birth certificate data to construct the reproductive history for 239 mothers. Univariable and bivariable analyses were conducted to determine the proportion of mothers delivering a live birth and associated factors. By the time of the current study, 96 (40.2%) of the 239 mothers had at least one live birth following delivery of their oldest affected male child; 53 (22.2%) of these mothers had a live birth before and 43 (18.0%) had a live birth after DBMD diagnosis of a male child. Mothers with a live birth after diagnosis were significantly younger at diagnosis of the oldest affected male child (26.2 ± 4.2 years vs. 31.5 ± 5.5 years), and were less likely to be white non-Hispanic compared to those with no live birth after diagnosis. These results suggest that about one in five mothers deliver a live birth subsequent to DBMD diagnosis in a male child. Maternal age and race/ethnicity were associated with this reproductive choice.

Australian women's experiences of wearing a non-invasive fetal electrocardiography (NIFECG) device during labour.

BACKGROUND: Continuous electronic fetal monitoring devices can restrict women's freedom of movement and choice of positioning during labour and birth. Despite the use of continuous electronic fetal monitoring for the past 50 years, little attention has been paid to women's experiences of wearing different fetal monitoring devices in labour. AIM: To explore women's views and experiences of wearing a beltless continuous electronic fetal monitoring device, the non-invasive fetal electrocardiogram during labour. METHODS: A qualitative descriptive approach was taken. Recruitment was via a larger clinical feasibility study. Some women who consented to take part in the clinical feasibility study also consented to being interviewed during the postnatal period. Transcripts were thematically analysed. FINDINGS: Women reported improved comfort when wearing the non-invasive fetal electrocardiogram device. They appreciated how it enabled freedom of movement and an ability to actively participate in labour. They compared their experience with previous use of cardiotocography which they felt compromised their bodily autonomy. All forms of continuous electronic fetal monitoring experienced by women resulted in the unwelcome experience of 'Poking and prodding' by the midwife. DISCUSSION: Continuous electronic fetal monitoring can negatively impact women's labour and birth experience, particularly when the measurement of fetal wellbeing is prioritised. CONCLUSION: The way in which continuous electronic fetal monitoring technology is designed and used is an important component of optimising physiological processes and positive experiences for women during labour and birth for women with complex pregnancies. Non-invasive fetal electrocardiograpy is a promising additional option for women.