Real-World Clinical Profile of Patients Prescribed Evolocumab in Japan.

BACKGROUND: Real-world utilization data for evolocumab, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be introduced in Japan in 2016, to date are limited. This study aimed to clarify the current real-world patient user profiles of evolocumab based on large-scale health claims data.Methods and Results: This retrospective database study examined patients from a health administrative database (MDV database) who initiated evolocumab between April 2016 (baseline) and November 2021. Characteristics and clinical profiles of this patient population are described. In all, 4,022 patients were included in the final analysis. Most evolocumab prescriptions occurred in the outpatient setting (3,170; 78.82%), and 940 patients (23.37%) had a recent diagnosis of familial hypercholesterolemia. Common recent atherosclerotic cardiovascular disease events at baseline included myocardial infarction (1,633; 40.60%), unstable angina (561; 13.95%), and ischemic stroke (408; 10.14%). Comorbidity diseases included hypertension (2,504; 62.26%), heart failure (1,750; 43.51%), diabetes (1,199; 29.81%), and chronic kidney disease (297; 7.38%). Among the lipid-lowering regimens concomitant with evolocumab, ezetimibe+statin was used most frequently (1,281; 31.85%), followed by no concomitant lipid-lowering regimen (1,190; 29.59%), statin (950; 23.62%), and ezetimibe (601; 14.94%). The median evolocumab treatment duration for all patients was 260 days (interquartile range 57-575 days). CONCLUSIONS: This study provides real-world insights into evolocumab utilization in Japan for optimizing patient care and adherence to guideline-based therapies to better address hypercholesterolemia in Japan.

Perinatal outcomes of women with gestational breast cancer in Australia and New Zealand: A prospective population-based study.

OBJECTIVE: To determine the epidemiology, clinical management, and outcomes of women with gestational breast cancer (GBC). METHODS: A population-based prospective cohort study was conducted in Australia and New Zealand between 2013 and 2014 using the Australasian Maternity Outcomes Surveillance System (AMOSS). Women who gave birth with a primary diagnosis of breast cancer during pregnancy were included. Data were collected on demographic and pregnancy factors, GBC diagnosis, obstetric and cancer management, and perinatal outcomes. The main outcome measures were preterm birth, maternal complications, breastfeeding, and death. RESULTS: Forty women with GBC (incidence 7.5/100 000 women giving birth) gave birth to 40 live-born babies. Thirty-three (82.5%) women had breast symptoms at diagnosis. Of 27 women diagnosed before 30 weeks' gestation, 85% had breast surgery and 67% had systemic therapy during pregnancy. In contrast, all 13 women diagnosed from 30 weeks had their cancer management delayed until postdelivery. There were 17 preterm deliveries; 15 were planned. Postpartum complications included the following: hemorrhage (n = 4), laparotomy (n = 1), and thrombocytopenia (n = 1). There was one late maternal death. Eighteen (45.0%) women initiated breastfeeding, including 12 of 23 women who had antenatal breast surgery. There were no perinatal deaths or congenital malformations, but 42.5% of babies were preterm, and 32.5% were admitted for higher-level neonatal care. CONCLUSIONS: Gestational breast cancer diagnosed before 30 weeks' gestation was associated with surgical and systemic cancer care during pregnancy and planned preterm birth. In contrast, cancer treatment was deferred to postdelivery for women diagnosed from 30 weeks, reflecting the complexity of managing expectant mothers with GBC in multidisciplinary care settings.

Pregnancy and birth outcomes of single versus multiple embryo transfer in gestational surrogacy arrangements: a systematic review and meta-analysis.

Multiple embryo transfer (MET) is associated with both an increased risk of multiple pregnancy and of live birth. In recent years, MET has become standard practice for most surrogacy arrangements. There is limited review of the use of MET versus single embryo transfer (SET) in surrogacy practice. The present review systematically evaluated the pregnancy outcomes of surrogacy arrangements between MET versus SET among gestational carriers. A systematic search of five computerized databases without restriction to the English language or study type was conducted to evaluate the primary outcomes: (i) clinical pregnancy; (ii) live delivery; and (iii) multiple delivery rates. The search returned 97 articles, five of which met the inclusion criteria. The results showed that clinical pregnancy (RR = 1.21, 95% CI: 1.06-1.39, n = 5, I2 = 41%), live delivery (RR = 1.29, 95% CI: 1.10-1.51, n = 4, I2 = 35%) and multiple delivery rates (RR = 1.42, 95% CI: 6.58-69.73, n = 4, I2 = 54%) were statistically significantly different in MET compared to SET. Adverse events including miscarriage, preterm birth and low birthweight were found following MET. Our findings support the existing evidence that MET results in multiple pregnancy and subsequently more adverse outcomes compared to SET. From a public health perspective, SET should be advocated as the preferred treatment for gestational carriers.

'Battery hens' or 'nuggets of gold': a qualitative study on the barriers and enablers for altruistic egg donation.

The demand for donated eggs outstrips supply in countries such as Australia where only altruistic egg donation is permitted. We conducted semi-structured interviews with women (n = 18), who had donated eggs in Australia in the last three years, to identify barriers and enablers for altruistic egg donation. Women reported difficulties in accessing trusted information on all aspects of egg donation and limited public awareness about the need for donor eggs. They generally had a good experience of pre-donation counselling and of the care provided by the fertility clinic staff. However, post-donation follow-up was deemed inadequate. Participants offered suggestions for how public education campaigns could enhance awareness about egg donation and how clinics could improve the post-donation experience. The findings indicate that the availability of independent, easily accessible, evidence-based information on egg donation; improved public awareness about the need for donor eggs; and proactive recruitment of donors may increase the local supply of donor eggs. Better clinic follow-up care, including post-donation counselling, would improve donors' experience of altruistic egg donation.

Gestational breast cancer in New South Wales: A population-based linkage study of incidence, management, and outcomes.

BACKGROUND: The incidence of gestational breast cancer (GBC) is increasing in high-income countries. Our study aimed to examine the epidemiology, management and outcomes of women with GBC in New South Wales (NSW), Australia. METHODS: A retrospective cohort study using linked data from three NSW datasets. The study group comprised women giving birth with a first-time diagnosis of GBC while the comparison group comprised women giving birth without any type of cancer. Outcome measures included incidence of GBC, maternal morbidities, obstetric management, neonatal mortality, and preterm birth. RESULTS: Between 1994 and 2013, 122 women with GBC gave birth in NSW (crude incidence 6.8/ 100,000, 95%CI: 5.6-8.0). Women aged ≥35 years had higher odds of GBC (adjusted odds ratio (AOR) 6.09, 95%CI 4.02-9.2) than younger women. Women with GBC were more likely to give birth by labour induction or pre-labour CS compared to women with no cancer (AOR 4.8, 95%CI: 2.96-7.79). Among women who gave birth by labour induction or pre-labour CS, the preterm birth rate was higher for women with GBC than for women with no cancer (52% vs 7%; AOR 17.5, 95%CI: 11.3-27.3). However, among women with GBC, preterm birth rate did not differ significantly by timing of diagnosis or cancer stage. Babies born to women with GBC were more likely to be preterm (AOR 12.93, 95%CI 8.97-18.64), low birthweight (AOR 8.88, 95%CI 5.87-13.43) or admitted to higher care (AOR 3.99, 95%CI 2.76-5.76) than babies born to women with no cancer. CONCLUSION: Women aged ≥35 years are at increased risk of GBC. There is a high rate of preterm birth among women with GBC, which is not associated with timing of diagnosis or cancer stage. Most births followed induction of labour or pre-labour CS, with no major short term neonatal morbidity.

Having a baby in your 40s with assisted reproductive technology: The reproductive dilemma of autologous versus donor oocytes.

BACKGROUND: Increasing numbers of women ≥40 years old are accessing assisted reproductive technology (ART) due to age-related infertility. There is limited population-based evidence about the impact on the cumulative live birth rate (CLBR) of women aged ≥40 years using their own oocytes, compared to women of a similar age, using donor oocytes. AIMS: To compare the CLBR for women ≥40 years undergoing ART using autologous oocytes and women of similar age using donor oocytes. MATERIALS AND METHODS: This population-based retrospective cohort study used data from all women aged ≥40 years undergoing ART with donated (n = 987) or autologous oocytes (n = 19 170) in Victoria, Australia between 2009 and 2016. A discrete-time survival model was used to evaluate the CLBR following ART with donor or autologous oocytes. The odds ratio, adjusted for woman's age; male age; parity; cause of infertility; and the associated 95% confidence intervals (CI), were calculated. The numbers needed to be exposed (NNEs) were calculated from the adjusted odds ratio (aOR) and the CLBR in the autologous group. RESULTS: The CLBR ranged from 28.6 to 42.5% in the donor group and from 12.5% to 1.4% in the autologous group. The discrete-time survival analysis with 95% CI demonstrated significant aOR on CLBR across all ages (range aOR: 2.56, 95% CI: 1.62-4.01 to aOR: 15.40, 95% CI: 9.10-26.04). CONCLUSIONS: Women aged ≥40 years, using donor oocytes had a significantly higher CLBR than women using autologous oocytes. The findings can be used when counselling women ≥40 years about their ART treatment options and to inform public policy.

Anxiety, depression and social support in pregnant women with a history of recurrent miscarriage: a cross-sectional study.

Objective: This study aims to investigate the prevalence of anxiety and depressive symptoms and the associations between social support and anxiety/depressive symptoms amongst Chinese pregnant women with a history of recurrent miscarriage. Methods: A cross-sectional study was conducted in Guangzhou, China, between September 2016 and May 2017 with 278 Chinese pregnant women with a history of recurrent miscarriage. Measures included the Self-rating Anxiety Scale (SAS), the Edinburgh Postnatal Depression Scale (EPDS) and the Perceived Social Support Scale (PSSS). Results: The occurrence of anxiety (SAS ≥ 50) and depressive symptoms (EPDS ≥ 13) were 45.0% and 37.0%, respectively. The women reported moderate level of social support. The low and moderate level of social support and education of high school or below were the predictors for anxiety and depressive symptoms. The other predictors for anxiety symptoms were having been married for ≥5 years and no child. Another predictor for depressive symptoms was aged ≥35 years. Anxiety predicted depressive symptoms. Conclusion: The results suggest early routine screening for anxiety and depressive symptoms amongst the Chinese pregnant women with a history of recurrent miscarriage. Health-care professionals should give more effort to enhance these women's social support to decrease their anxiety and depressive symptoms.

In utero exposure to breast cancer treatment: a population-based perinatal outcome study.

Chemotherapy during a viable pregnancy may be associated with adverse perinatal outcomes. We conducted a prospective cohort study to examine the perinatal outcomes of babies born following in utero exposure to chemotherapy in Australia and New Zealand. Over 18 months we identified 24 births, of >400 g and/or >20-weeks' gestation, to women diagnosed with breast cancer in the first or second trimesters. Eighteen babies were exposed in utero to chemotherapy. Chemotherapy commenced at a median of 20 weeks gestation, for a mean duration of 10 weeks. Twelve exposed infants were born preterm with 11 by induced labour or pre-labour caesarean section. There were no perinatal deaths or congenital malformations. Our findings show that breast cancer diagnosed during mid-pregnancy is often treated with chemotherapy. Other than induced preterm births, there were no serious adverse perinatal outcomes.

Oocyte donor age has a significant impact on oocyte recipients' cumulative live-birth rate: a population-based cohort study.

OBJECTIVE: To study the impact of the donor's and recipient's age on the cumulative live-birth rate (CLBR) in oocyte donation cycles. DESIGN: A population-based retrospective cohort study. SETTING: Not applicable. PATIENT(S): All women using donated oocytes (n = 1,490) in Victoria, Australia, between 2009 and 2015. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The association between the donor's and recipient's age and CLBR modeled by multivariate Cox proportional hazard regression with the covariates of male partner's age, recipient parity, and cause of infertility adjusted for, and donor age grouped as <30, 30-34, 35-37, 38-40, and ≥41 years, and recipient age as <35, 35-37, 38-40, 41-42, 43-44, and ≥45 years. RESULT(S): The mean age of the oocyte donors was 33.7 years (range: 21 to 45 years) with 49% aged 35 years and over. The mean age of the oocyte recipients was 41.4 years (range: 19 to 53 years) with 25.4% aged ≥45 years. There was a statistically significant relationship between the donor's age and the CLBR. The CLBR for recipients with donors aged <30 years and 30-34 years was 44.7% and 43.3%, respectively. This decreased to 33.6% in donors aged 35-37 years, 22.6% in donors aged 38-40 years, and 5.1% in donors aged ≥41 years. Compared with recipients with donors aged <30 years, the recipients with donors aged 38-40 years had 40% less chance of achieving a live birth (adjusted hazard ratio 0.60; 95% CI, 0.43-0.86) and recipients with donors aged ≥41 years had 86% less chance of achieving a live birth (adjusted hazard ratio 0.14; 95% CI, 0.04-0.44). The multivariate analysis showed no statistically significant effect of the recipient's age on CLBR. CONCLUSION(S): We have demonstrated that the age of the oocyte donor is critical to the CLBR and is independent of the recipient woman's age. Recipients using oocytes from donors aged ≥35 years had a statistically significantly lower CLBR when compared with recipients using oocytes from donors aged <35 years.

Glucose screening within six months postpartum among Chinese mothers with a history of gestational diabetes mellitus: a prospective cohort study.

BACKGROUND: Gestational diabetes mellitus (GDM) is a risk factor for diabetes mellitus. The 75-g, 2-h oral glucose tolerance test is recommended for mothers with a history of GDM to screen for diabetes in the postnatal period. The aim of this study was to investigate the rate of glucose screening within 6 months postpartum among Chinese mothers with a history of GDM, and to identify its predictors. METHODS: A prospective cohort study was conducted in a regional teaching hospital in Guangzhou, China, between July 2016 and June 2017. The participants were Chinese mothers (n = 237) who were diagnosed with GDM, were aged 18 years or older with no serious physical or mental disease and had not been diagnosed with type 1 or type 2 diabetes prior to their pregnancy. The revised Chinese version of the Champion's Health Belief Model Scale and social-demographic and perinatal characteristics factors were collected and used to predict postpartum glucose screening (yes or no). Adjust odds ratio (AOR) and 95% confidence interval (95% CI) were calculated. RESULTS: The mean age of the 237 mothers was 32.70 years (range from 22 to 44). Almost half of the mothers (45.6%) were college graduates or higher. Chinese mothers reported a high level of perceived benefits, self-efficacy, and health motivation towards postpartum glucose screening, with a mean score above 3.5. Chinese mothers were more likely to undertake postpartum glucose screening if they were a first-time mother [AOR 2.618 (95% CI: 1.398-4.901)], had a high perceived susceptibility score [AOR 2.173 (95% CI: 1.076-4.389)], a high perceived seriousness score [AOR 1.988 (95%CI: 1.020-3.875)] and high perceived benefits score [AOR 2.978 (95%CI: 1.540-5.759)]. CONCLUSION: The results of this study will lead to better identification of mothers with a history of GDM who may not screen for postpartum glucose abnormality. Health care professionals should be cognizant of issues that may affect postpartum glucose screening among mothers with a history of GDM, including parity, perceived susceptibility, perceived seriousness and perceived benefits.

Obstetric anal sphincter injuries among women with gestational diabetes and women without gestational diabetes: A NSW population-based cohort study.

BACKGROUND: Obstetric anal sphincter injuries (OASIs) are associated with maternal morbidity; however, it is uncertain whether gestational diabetes (GDM) is an independent risk factor when considering birthweight mode of birth and episiotomy. AIMS: To compare rates of OASIs between women with GDM and women without GDM by mode of birth and birthweight. To investigate the association between episiotomy, mode of birth and the risk of OASIs. METHODS: A population-based cohort study of women who gave birth vaginally in NSW, from 2007 to 2013. Rates of OASIs were compared between women with and without GDM, stratified by mode of birth, birthweight and a multi-categorical variable of mode of birth and episiotomy. Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were calculated by multivariable logistic regression. RESULTS: The rate of OASIs was 3.6% (95% CI: 2.6-2.7) vs 2.6% (95% CI: 3.4-2.8; P < 0.001) among women with and without GDM, respectively. Women with GDM and a macrosomic baby (birthweight ≥ 4000 g) had a higher risk of OASIs with forceps (aOR 1.76, 95% CI: 1.08-2.86, P = 0.02) or vacuum (aOR 1.89, 95% CI: 1.17-3.04, P = 0.01), compared with those without GDM. For primiparous women with GDM and all women without GDM, an episiotomy with forceps was associated with lower odds of OASIs than forceps only (primiparous GDM, forceps-episiotomy aOR 2.49, 95% CI: 2.00-3.11, forceps aOR 5.30, 95% CI: 3.72-7.54), (primiparous without GDM, forceps-episiotomy aOR 2.71, 95% CI: 2.55-2.89, forceps aOR 5.95, 95% CI: 5.41-6.55) and (multiparous without GDM, forceps-episiotomy aOR 3.75, 95% CI: 3.12-4.50, forceps aOR 6.20, 95% CI: 4.96-7.74). CONCLUSION: Women with GDM and a macrosomic baby should be counselled about the increased risk of OASIs with both vacuum and forceps. With forceps birth, this risk can be partially mitigated by performing a concomitant episiotomy.

Are health facilities well equipped to provide basic quality childbirth services under the free maternal health policy? Findings from rural Northern Ghana.

BACKGROUND: Basic inputs and infrastructure including drugs, supplies, equipment, water and electricity are required for the provision of quality care. In the era of the free maternal health policy in Ghana, it is unclear if such basic inputs are readily accessible in health facilities. The study aimed to assess the availability of basic inputs including drugs, supplies, equipment and emergency transport in health facilities. Women and health providers' views on privacy and satisfaction with quality of care were also assessed. METHODS: The study used a convergent parallel mixed methods in one rural municipality in Ghana, Kassena-Nankana. A survey among facilities (n = 14) was done. Another survey was carried out among women who gave birth in health facilities only (n = 353). A qualitative component involved focus group discussions (FGDs) with women (n = 10) and in-depth interviews (IDIs) with midwives and nurses (n = 25). Data were analysed using descriptive statistics for the quantitative study, while the qualitative data were recorded, transcribed, read and coded using themes. RESULTS: The survey showed that only two (14%) out of fourteen facilities had clean water, and five (36%) had electricity. Emergency transport for referrals was available in only one (7%) facility. Basic drugs, supplies, equipment and infrastructure especially physical space were inadequate. Rooms used for childbirth in some facilities were small and used for multiple purposes. Eighty-nine percent (n = 314) of women reported lack of privacy during childbirth and this was confirmed in the IDIs. Despite this, 77% of women (n = 272) were very satisfied or satisfied with quality of care for childbirth which was supported in the FGDs. Reasons for women's satisfaction included the availability of midwives to provide childbirth services and to have follow-up homes visits. Some midwives were seen to be patient and empathetic. Providers were not satisfied due to health system challenges. CONCLUSION: Government should dedicate more resources to the provision of essential inputs for CHPS compounds providing maternal health services. Health management committees should also endeavour to play an active role in the management of health facilities to ensure efficiency and accountability. These would improve quality service provision and usage, helping to achieve universal health coverage.

Neonatal outcomes among twins following assisted reproductive technology: an Australian population-based retrospective cohort study.

BACKGROUND: While their incidence is on the rise, twin pregnancies are associated with risks to the mothers and their babies. This study aims to investigate the likelihood of adverse neonatal outcomes of twins following assisted reproductive technology (ART) compared to non-ART twins. METHODS: A retrospective population study using the Australian National Perinatal Data Collections (NPDC) which included 19,662 twins of ≥20 weeks gestational age or ≥ 400 g birthweight in Australia. Maternal outcomes and neonatal outcomes (preterm birth, low birth weight, resuscitation and neonatal death) were compared. Generalized Estimating Equations were used to assess the likelihood of any neonatal outcomes, with adjusted odds ratio (AOR) and 95% confidence intervals (CI) presented. Weinberg's differential rule was used to estimate monozygotic twin rate. RESULTS: ART mothers were 3.3 years older than non-ART mothers. The rates of pregnancy-induced hypertension and gestational diabetes were significantly higher for ART mothers than non-ART mothers (12.2% vs. 8.4%, p <  0.01) and (9.7% vs. 7.5%, p <  0.01) respectively. The incidence of monozygotic twins was 2.0% for ART twins and 1.1% for non-ART twins. Compared with non-ART twins, ART twins had higher rates of preterm birth (AOR 1.13, 95% CI: 1.05-1.22), low birth weight (AOR 1.13, 95% CI: 1.05-1.22), and resuscitation (AOR 1.26, 95% CI: 1.17-1.36). Liveborn ART twins had 28% (AOR 1.28, 95% CI 1.09-1.50) increased odds of having any adverse neonatal outcome compared to liveborn non-ART twins, especially for opposite-sex ART twins (AOR 1.42, 95% CI 1.11-1.82). CONCLUSION: As ART twins had higher rates of adverse outcome, special prenatal care is recommended. Couples accessing ART should be fully informed of the risk of adverse outcome of twin pregnancies.

The implementation of the free maternal health policy in rural Northern Ghana: synthesised results and lessons learnt.

OBJECTIVE: A free maternal health policy was implemented under Ghana's National Health Insurance Scheme to promote the use of maternal health services. Under the policy, women are entitled to free services throughout pregnancy and at childbirth. A mixed methods study involving women, providers and insurance managers was carried out in the Kassena-Nankana municipality of Ghana. It explored the affordability, availability, acceptability and quality of services. In this manuscript, we present synthesised results categorised as facilitators and barriers to access as well as lessons learnt (implications). RESULTS: Reasonable waiting times, cleanliness of facilities as well as good interpersonal relationships with providers were the facilitators to access. Barriers included out of pocket payments, lack of, or inadequate supply of drugs and commodities, equipment, water, electricity and emergency transport. Four lessons (implications) were identified. Firstly, out of pocket payments persisted. Secondly, the health system was not strengthened before implementing the free maternal health policy. Thirdly, lower level facilities were poorly resourced. Finally, the lack of essential inputs and infrastructure affected quality of care and therefore, access to care. It is suggested that the Government of Ghana, the Health Insurance Scheme and other stakeholders improve the provision of resources to facilities.

Neonatal outcomes of live-born term singletons in vertex presentation born to mothers with diabetes during pregnancy by mode of birth: a New South Wales population-based retrospective cohort study.

OBJECTIVES: To investigate the association between the mode of birth and adverse neonatal outcomes of macrosomic (birth weight ≥4000 g) and non-macrosomic (birth weight <4000 g) live-born term singletons in vertex presentation (TSV) born to mothers with diabetes (pre-existing and gestational diabetes mellitus (GDM)). DESIGN: A population-based retrospective cohort study. SETTING: New South Wales, Australia. PATIENTS: All live-born TSV born to mothers with diabetes from 2002 to 2012. INTERVENTION: Comparison of neonatal outcomes by mode of birth (prelabour caesarean section (CS) and planned vaginal birth resulted in intrapartum CS, non-instrumental or instrumental vaginal birth). MAIN OUTCOME MEASURES: Five-minute Apgar score <7, admission to neonatal intensive care unit (NICU) or special care nursery (SCN) and the need for resuscitation. RESULTS: Among the 48 882 TSV born to mothers with diabetes, prelabour CS was associated with a significant increase in the rate of admission to NICU/SCN compared with planned vaginal birth.For TSV born to mothers with pre-existing diabetes, compared with non-instrumental vaginal birth, instrumental vaginal birth was associated with increased odds of the need for resuscitation in macrosomic (adjusted ORs (AOR) 2.6; 95% CI (1.2 to 7.5)) and non-macrosomic TSV (AOR 3.3; 95% CI (2.2 to 5.0)).For TSV born to mothers with GDM, intrapartum CS was associated with increased odds of the need for resuscitation compared with non-instrumental vaginal birth in non-macrosomic TSV (AOR 2.3; 95% CI (2.1 to 2.7)). Instrumental vaginal birth was associated with increased likelihood of requiring resuscitation compared with non-instrumental vaginal birth for both macrosomic (AOR 2.3; 95% CI (1.7 to 3.1)) and non-macrosomic (AOR 2.5; 95% CI (2.2 to 2.9)) TSV. CONCLUSION: Pregnant women with diabetes, particularly those with suspected fetal macrosomia, need to be aware of the increased likelihood of adverse neonatal outcomes following instrumental vaginal birth and intrapartum CS when planning mode of birth.

Cesarean section and diabetes during pregnancy: An NSW population study using the Robson classification.

AIM: The aim of this study was to identify the main contributors to cesarean section (CS) among women with and without diabetes during pregnancy using the Robson classification and to compare CS rates within Robson groups. METHODS: A population-based cohort study was conducted of all women who gave birth in New South Wales, Australia, between 2002 and 2012. Women with pregestational diabetes (types 1 and 2) and gestational diabetes mellitus (GDM) were grouped using the Robson classification. Adjusted odd ratios (AOR) and 95% confidence intervals (CI) were calculated using multivariable logistic regression. RESULTS: The total CS rate was 53.6% for women with pregestational diabetes, 36.8% for women with GDM and 28.5% for women without diabetes. Previous CS contributed the most to the total number of CS in all populations. For preterm birth, the contribution to the total was 20.5% for women with pregestational diabetes and 5.7% for women without diabetes. Compared to women without diabetes, for nulliparous with pregestational diabetes, the odds of CS was 1.4 (95% CI, 1.1-1.8) for spontaneous labor and 2.0 (95% CI, 1.7-2.3) for induction of labor. CONCLUSION: A history of CS was the main contributor to the total CS. Reducing primary CS is the first step to lowering the high rate of CS among women with diabetes. Nulliparous women were more likely to have CS if they had pregestational diabetes. This increase was also evident in all multiparous women giving birth. The high rate of preterm births and CS reflects the clinical issues for women with diabetes during pregnancy.

Has the free maternal health policy eliminated out of pocket payments for maternal health services? Views of women, health providers and insurance managers in Northern Ghana.

INTRODUCTION: The free maternal health policy was implemented in Ghana in 2008 under the National Health Insurance Scheme (NHIS). The policy sought to eliminate out of pocket (OOP) payments and enhance the utilisation of maternal health services. It is unclear whether the policy had altered OOP payments for services. The study explored views on costs and actual OOP payments during pregnancy. The source of funding for payments was also explored. METHODS: A convergent parallel mixed methods design, involving quantitative and qualitative data collection approaches. The study was set in the Kassena-Nankana municipality, a rural area in Ghana. Women (n = 406) who utilised services during pregnancy were surveyed. Also, 10 focus groups discussions (FGDs) were held with women who used services during pregnancy as well as 28 in-depth interviews (IDIs) with midwives/nurses (n = 25) and insurance managers/directors (n = 3). The survey was analysed using descriptive statistics, focussing on costs from the women's perspective. Qualitative data were audio recorded, transcribed and translated verbatim into English where necessary. The transcripts were read and coded into themes and sub-themes. RESULTS: The NHIS did not cover all expenses in relation to maternal health services. The overall mean for OOP cost during pregnancy was GH¢17.50 (US$8.60). Both FGDs and IDIs showed that women especially paid for drugs and ultrasound scan services. Sixty-five percent of the women used savings, whilst twenty-two percent sold assets to meet the OOP cost. Some women were unable to afford payments due to poverty and had to forgo treatment. Participants called for payments to be eliminated and for the NHIS to absorb the cost of emergency referrals. All participants admitted the benefits of the policy. CONCLUSION: Women needed to make payments despite the policy. Measures should be put in place to eliminate payments to enable all women to receive services and promote universal health coverage.

Gestational age-specific perinatal mortality rates for assisted reproductive technology (ART) and other births.

STUDY QUESTION: Is perinatal mortality rate higher among births born following assisted reproductive technology (ART) compared to non-ART births? SUMMARY ANSWER: Overall perinatal mortality rates in ART births was higher compared to non-ART births, but gestational age-specific perinatal mortality rate of ART births was lower for very preterm and moderate to late preterm births. WHAT IS KNOWN ALREADY: Births born following ART are reported to have higher risk of adverse perinatal outcomes compared to non-ART births. STUDY DESIGN, SIZE, DURATION: This population-based retrospective cohort study included 407 368 babies (391 952 non-ART and 15 416 ART)-393 491 singletons and 10 877 twins or high order multiples. PARTICIPANTS/MATERIALS, SETTING, METHODS: All births (≥20 weeks of gestation and/or ≥400 g of birthweight) in five states and territories in Australia during the period 2007-2009 were included in the study, using National Perinatal Data Collection (NPDC). Primary outcome measures were rates of stillbirth, neonatal and perinatal deaths. Adjusted odds ratio (AOR) and 95% confidence interval (CI) were used to estimate the likelihood of perinatal death. MAIN RESULTS AND THE ROLE OF CHANCE: Rates of multiple birth and low birthweight were significantly higher in ART group compared to the non-ART group (P < 0.01). Overall perinatal mortality rate was significantly higher for ART births (16.5 per 1000 births, 95% CI 14.5-18.6), compared to non-ART births (11.3 per 1000 births, 95% CI 11.0-11.6) (AOR 1.45, 95% CI 1.26-1.68). However, gestational age-specific perinatal mortality rate of ART births (including both singletons and multiples) was lower for very preterm (<32 weeks' gestation) and moderate to late preterm births (32-36 weeks' gestation) (AOR 0.61, 95% CI 0.53-0.70 and AOR 0.61, 95% CI 0.53-0.70, respectively) compared to non-ART births. Congenital abnormality and spontaneous preterm were the most common causes of neonatal deaths in both ART and non-ART group. LIMITATIONS, REASONS FOR CAUTION: Due to different cut-off limit for perinatal period in Australia, the results of this study should be interpreted with cautions for other countries. Australian definition of perinatal period commences at 20 completed weeks (140 days) of gestation and ends 27 completed days after birth which is different from the definition by World Health Organisation (commences at 22 completed weeks (154 days) of gestation and ends seven completed days after birth) and by Centers for Disease Control and Prevention (includes infant deaths under age 7 days and fetal deaths at 28 weeks of gestation or more). WIDER IMPLICATIONS OF THE FINDINGS: Preterm birth is the single most important contributing factor to increased risk of perinatal mortality among ART singletons compared to non-ART singletons. Further research on reducing early preterm delivery, with the aim of reducing the perinatal mortality among ART births is needed. Couples who access ART treatment should be fully informed regarding the risk of preterm birth and subsequent risk of perinatal death. STUDY FUNDING/COMPETING INTEREST(S): There was no funding associated with this study. No conflict of interest was declared.

The operations of the free maternal care policy and out of pocket payments during childbirth in rural Northern Ghana.

BACKGROUND: To promote skilled attendance at births and reduce maternal deaths, the government of Ghana introduced the free maternal care policy under the National Health Insurance Scheme (NHIS) in 2008. The objective is to eliminate financial barriers associated with the use of services. But studies elsewhere showed that out of pocket (OOP) payments still exist in the midst of fee exemptions. The aim of this study was to estimate OOP payments and the financial impact on women during childbirth in one rural and poor area of Northern Ghana; the Kassena-Nankana municipality. Costs were taken from the perspective of women. METHODS: Quantitative and qualitative data collection techniques were used in a convergent parallel mixed methods study. The study used structured questionnaire (n = 353) and focus group discussions (FGDs =7) to collect data from women who gave birth in health facilities. Quantitative data from the questionnaire were analysed, using descriptive statistics. Qualitative data from the FGDs were recorded, transcribed and analysed to determine common themes. RESULTS: The overall mean OOP payments during childbirth was GH¢33.50 (US$17), constituting 5.6% of the average monthly household income. Over one-third (36%, n = 145) of women incurred OOP payments which exceeded 10% of average monthly household income (potentially catastrophic). Sixty-nine percent (n = 245) of the women perceived that the NHIS did not cover all expenses incurred during childbirth; which was confirmed in the FGDs. Both survey and FGDs demonstrated that women made OOP payments for drugs and other supplies. The FGDs showed women bought disinfectants, soaps, rubber pads and clothing for newborns as well. Seventy-five percent (n = 264) of the women used savings, but 19% had to sell assets to finance the payments; this was supported in the FGDs. CONCLUSION: The NHIS policy has not eliminated financial barriers associated with childbirth which impacts the welfare of some women. Women continued to make OOP payments, largely as a result of a delay in reimbursement by the NHIS. There is need to re-examine the reimbursement system in order to prevent shortage of funding to health facilities and thus encourage skilled attendance for the reduction of maternal deaths as well as the achievement of universal health coverage.

Morbidity and mortality among very preterm singletons following fertility treatment in Australia and New Zealand, a population cohort study.

BACKGROUND: Due to high rates of multiple birth and preterm birth following fertility treatment, the rates of mortality and morbidity among births following fertility treatment were higher than those conceived spontaneously. However, it is unclear whether the rates of adverse neonatal outcomes remain higher for very preterm (<32 weeks gestational age) singletons born after fertility treatment. This study aims to compare adverse neonatal outcomes among very preterm singletons born after fertility treatment including assisted reproductive technology (ART) hyper-ovulution (HO) and artificial insemination (AI) to those following spontaneous conception. METHODS: The population cohort study included 24069 liveborn very preterm singletons who were admitted to Neonatal Intensive Care Unit (NICU) in Australia and New Zealand from 2000 to 2010. The in-hospital neonatal mortality and morbidity among 21753 liveborn very preterm singletons were compared by maternal mode of conceptions: spontaneous conception, HO, ART and AI. Univariate and multivariate binary logistic regression analysis was used to examine the association between mode of conception and various outcome factors. Odds ratio (OR) and adjusted odds ratio (AOR) and 95% confidence interval (CI) were calculated. RESULTS: The rate of small for gestational age was significantly higher in HO group (AOR 1.52, 95% CI 1.02-2.67) and AI group (AOR 2.98, 95% CI 1.53-5.81) than spontaneous group. The rate of birth defect was significantly higher in ART group (AOR 1.71, 95% CI 1.36-2.16) and AI group (AOR 3.01, 95% CI 1.47-6.19) compared to spontaneous group. Singletons following ART had 43% increased odds of necrotizing enterocolitis (AOR 1.43, 95% CI 1.04-1.97) and 71% increased odds of major surgery (AOR 1.71, 95% CI 1.37-2.13) compared to singletons conceived spontaneously. Other birth and NICU outcomes were not different among the comparison groups. CONCLUSIONS: Compared to the spontaneous conception group, risk of congenital abnormality significantly increases after ART and AI; the risk of morbidities increases after ART, HO and AI. Preconception planning should include comprehensive information about the benefits and risks of fertility treatment on the neonatal outcomes.