Induction of labor and cesarean birth in lower-risk nulliparous women at term: A retrospective cohort study.

OBJECTIVE: To evaluate whether induction of labor (IOL) is associated with cesarean birth (CB) and perinatal mortality in uncomplicated first births at term compared with expectant management outside the confines of a randomized controlled trial. METHODS: Population-based retrospective cohort study of all births in Victoria, Australia, from 2010 to 2018 (n = 640,191). Preliminary analysis compared IOL at 37 weeks with expectant management at that gestational age and beyond for uncomplicated pregnancies. Similar comparisons were made for IOL at 38, 39, 40, and 41 weeks of gestation and expectant management. The primary analysis repeated these comparisons, limiting the population to nulliparous women with uncomplicated pregnancies and excluding those with a medical indication for IOL. We compared perinatal mortality between groups using Chi-square tests and multivariable logistic regression for all other comparisons. Adjusted odds ratios and 99% confidence intervals were reported. p < 0.01 denoted statistical significance. RESULTS: Among nulliparous, uncomplicated pregnancies at ≥37 weeks of gestation in Victoria, IOL increased from 24.6% in 2010 to 30.0% in 2018 (p < 0.001). In contrast to the preliminary analysis, the primary analysis showed that IOL in lower-risk nulliparous women was associated with increased odds of CB when performed at 38 (aOR 1.23(1.13-1.32)), 39 (aOR 1.31(1.23-1.40)), 40 (aOR 1.42(1.35-1.50)), and 41 weeks of gestation (aOR 1.43(1.35-1.51)). Perinatal mortality was rare in both groups and non-significantly lower in the induced group at most gestations. DISCUSSION: For lower-risk nulliparous women, the odds of CB increased with IOL from 38 weeks of gestation, along with decreased odds of perinatal mortality at 41 weeks only.

A double-blinded randomised controlled study of fluid restriction versus liberal fluid during induction of labour: A pilot study.

BACKGROUND: Excess intravenous fluid for women requiring an induction of labour may adversely affect the duration of labour and maternal/neonatal outcomes. AIMS: This study aimed to determine the difference in duration of labour and outcomes with a low background infusion rate, compared to liberal background intravenous fluid management. MATERIALS AND METHODS: A double blind randomised controlled pilot study was performed on 200 women who underwent induction of labour at a single institution. Women were randomised to an intravenous rate of 40 mL/h versus 250 mL/h of Hartmann's solution. Fluid boluses were strictly controlled to limit bias. This trial was registered with the Australian clinical trial registry: ACTRN12621001298808. RESULTS: Analysis of the total amount of fluid received showed good separation with Group 1 (40 mL/h) receiving 1,736 mL less than Group 2 (250 mL/h), median (interquartile range) 841 mL (458, 1691) versus 2,577 mL (1620, 4326) (P < 0.001). Median duration of labour was shorter in Group 1 by 24 min (P = ns). Subset analysis of nulliparous women showed that duration of labour was shorter in Group 1 by 83.5 min (P = ns). CONCLUSION: As this was a pilot study, a significant difference in duration of labour or secondary outcomes was not seen. Given the increasing numbers of nulliparous women having an induction of labour, potential for adverse maternal and neonatal outcomes and the associated higher rate of operative birth, this study guides power calculations and supports proof of concept for future research into optimum fluid management during induction of labour for these women.

Elective induction of labour at full-term gestations and childhood school outcomes.

AIM: To explore the association between induction of labour at full-term gestations in low-risk nulliparous women and childhood school outcomes. METHODS: A retrospective whole-of-population cohort study linking perinatal data to educational test scores at grades 3, 5 and 7 in Victoria, Australia. Low-risk nulliparous women with singleton pregnancies induced at 39 and 40 weeks without a medical indication were compared to those expectantly managed from that week of gestation. Multivariable logistic regressions were used as well as generalised estimating equations on longitudinal data. RESULTS: At 39 weeks, there were 3687 and 103 164 infants in the induction and expectant arms, respectively. At 40 weeks' gestation, there were 7914 and 70 280 infants, respectively. Infants born to nulliparous women induced at 39 weeks' gestation had significantly poorer educational outcomes at grade 3 (adjusted odds ratio (aOR) = 1.39, 95% confidence interval (CI): 1.13-1.70) but not grades 5 (aOR = 1.05, 95% CI: 0.84-1.33) and 7 (aOR = 1.07, 95% CI: 0.81-1.40) compared to those expectantly managed. Infants born to nulliparous women induced at 40 weeks had comparable educational outcomes at grade 3 (aOR = 1.06, 95% CI: 0.90-1.25) but poorer educational outcomes at grades 5 (aOR = 1.23, 95% CI: 1.05-1.43) and 7 (aOR = 1.23, 95% CI: 1.03-1.47) compared to those expectantly managed. CONCLUSIONS: There were inconsistent associations between elective induction of labour at full-term gestations in low-risk nulliparous women and impaired childhood school outcomes.

Effect of asthma management with exhaled nitric oxide versus usual care on perinatal outcomes.

INTRODUCTION: Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide (F ENO)-based asthma management improves perinatal outcomes compared to usual care. METHODS: The Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided by F ENO (adjustment of asthma treatment according to exhaled nitric oxide and symptoms each 6-12 weeks) to usual care (no treatment adjustment as part of the trial). The primary outcome was a composite of adverse perinatal events (preterm birth, small for gestational age (SGA), perinatal mortality or neonatal hospitalisation) assessed using hospital records. Secondary outcomes included maternal asthma exacerbations. Concealed random allocation, stratified by study site and self-reported smoking status was used, with blinded outcome assessment and statistical analysis (intention to treat). RESULTS: Pregnant women with current asthma were recruited; 599 to the control group (608 infants) and 601 to the intervention (615 infants). There were no significant group differences for the primary composite perinatal outcome (152 (25.6%) out of 594 control, 177 (29.4%) out of 603 intervention; OR 1.21, 95% CI 0.94-1.56; p=0.15), preterm birth (OR 1.14, 95% CI 0.78-1.68), SGA (OR 1.06, 95% CI 0.78-1.68), perinatal mortality (OR 3.62, 95% CI 0.80-16.5), neonatal hospitalisation (OR 1.24, 95% CI 0.89-1.72) or maternal asthma exacerbations requiring hospital admission or emergency department presentation (OR 1.19, 95% CI 0.69-2.05). CONCLUSION: F ENO-guided asthma pharmacotherapy delivered by a nurse or midwife in the antenatal clinic setting did not improve perinatal outcomes.

Bimanual examination for clot evacuation: a retrospective cohort study of women with postpartum haemorrhage after vaginal delivery.

BACKGROUND: Bimanual clot evacuation (BCE) is a simple clinical manoeuvre that may reduce need for surgical intervention in the management of severe postpartum haemorrhage (PPH). We sought to determine whether performing BCE in cases of severe PPH after vaginal birth reduces the need for surgical intervention. METHODS: A retrospective chart review of women who delivered vaginally with a severe PPH between January 1, 2011 and December 31, 2014 in a single tertiary women's hospital in Sydney, Australia was conducted. Severe PPH was classified as a blood loss ≥1000mls. The need for surgical management (including operating theatre uterine exploration or evacuation, intrauterine balloon tamponade, repair of significant trauma, uterine or internal iliac artery ligation, B-Lynch suture insertion or hysterectomy) was the primary outcome measure, as expressed by need for operating theatre utilisation. RESULTS: From a cohort of 438, 149 women (34.0%) had BCE, of whom 29 (19.5%) required surgical management compared to 103 of 289 women with no BCE (35.6%); an odds ratio (OR) of 0.38 for BCE (confidence interval 0.20-0.72; p = 0.003). Early BCE (< 1 h of delivery) was associated with a further reduction in surgery (OR 0.24; confidence interval 0.08-0.70; p = 0.009) compared to late BCE (> 1 h of delivery). There was no reduction in estimated blood loss (p = 0.86) or blood transfusion (p = 0.71) with BCE. CONCLUSION: Our study suggests BCE reduces theatre utilisation in the context of severe PPH following vaginal delivery. Prospective trials are needed to determine whether BCE should be endorsed as a treatment modality for PPH post-vaginal delivery.

Study protocol for a comparative effectiveness trial of two models of perinatal integrated psychosocial assessment: the PIPA project.

BACKGROUND: Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The primary aims of the PIPA Project are to examine the clinical- and cost-effectiveness of two alternative models of integrated psychosocial care during pregnancy: 'care as usual' (the SAFE START model) and an alternative model (the PIPA model). The acceptability and perceived benefit of each model of care from the perspective of both pregnant women and their healthcare providers will also be assessed. Our secondary aim is to examine the psychometric properties of a number of symptom-based screening tools for depression and anxiety when used in pregnancy. METHODS: This is a comparative-effectiveness study comparing 'care as usual' to an alternative model sequentially over two 12-month periods. Data will be collected from women at Time 1 (initial antenatal psychosocial assessment), Time 2 (2-weeks after Time 1) and from clinicians at Time 3 for each condition. Primary aims will be evaluated using a between-groups design, and the secondary aim using a within group design. DISCUSSION: The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman's psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines. TRIAL REGISTRATION: ACTRN12617000932369.

The Breathing for Life Trial: a randomised controlled trial of fractional exhaled nitric oxide (FENO)-based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health.

BACKGROUND: Asthma exacerbations are common during pregnancy and associated with an increased risk of adverse perinatal outcomes. Adjusting asthma treatment based on airway inflammation rather than symptoms reduces the exacerbation rate by 50 %. The Breathing for Life Trial (BLT) will test whether this approach also improves perinatal outcomes. METHODS/DESIGN: BLT is a multicentre, parallel group, randomised controlled trial of asthma management guided by fractional exhaled nitric oxide (FENO, a marker of eosinophilic airway inflammation) compared to usual care, with prospective infant follow-up. Women with physician-diagnosed asthma, asthma symptoms and/or medication use in the previous 12 months, who are 12-22 weeks gestation, will be eligible for inclusion. Women randomised to the control group will have one clinical assessment of their asthma, including self-management education. Any treatment changes will be made by their general practitioner. Women randomised to the intervention group will have clinical assessments every 3-6 weeks during pregnancy, and asthma treatments will be adjusted every second visit based on an algorithm which uses FENO to adjust inhaled corticosteroid (ICS) dose (increase in dose when FENO >29 parts per billion (ppb), decrease in dose when FENO <19 ppb, and no change when FENO is between 19 and 29 ppb). A long acting beta agonist (LABA) will be added when symptoms remain uncontrolled. Both the control and intervention groups will report on exacerbations at a postpartum phone interview. The primary outcome is adverse perinatal outcome (a composite measure including preterm birth, intrauterine growth restriction, neonatal hospitalisation at birth or perinatal mortality), assessed from hospital records. Secondary outcomes will be each component of the primary outcome, maternal exacerbations requiring medical intervention during pregnancy (both smokers and non-smokers), and hospitalisation and emergency department presentation for wheeze, bronchiolitis or croup in the first 12 months of infancy. Outcome assessment and statistical analysis of the primary outcome will be blinded. To detect a reduction in adverse perinatal outcomes from 35 % to 26 %, 600 pregnant women with asthma per group are required. DISCUSSION: This trial will provide evidence for the effectiveness of a FENO-based management strategy in improving perinatal outcomes in pregnant women with asthma. If successful, this would improve the management of pregnant women with asthma worldwide. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000202763 .

Supporting Women Planning a Vaginal Breech Birth: An International Survey.

OBJECTIVE: The aim of this study was to explore the experiences of women who planned a vaginal breech birth. METHOD: An online survey was developed consisting of questions regarding women's experiences surrounding planned vaginal breech birth. The survey was distributed between April 2014 and January 2015 to closed membership Facebook groups that had a consumer focus on vaginal breech birth. RESULTS: In total, 204 unique responses to the survey were obtained from women who had sought the option of a vaginal breech birth in a previous pregnancy. Most women (80.8%) stated that they were happy with the birth choices they made, and a significant proportion (89.4%) would attempt a vaginal breech birth in subsequent pregnancies. Less than half of women were formally referred to a clinician skilled in vaginal breech birth when their baby was diagnosed breech (41.8%), while the remainder sourced a clinician themselves. Half of the women felt supported by their care provider (56.7%) and less than half (42.3%) felt supported by family and friends. CONCLUSION: The women who responded to this international survey sought the option of a vaginal breech birth, were subsequently happy with this decision, and would attempt a vaginal breech birth in their next pregnancy. Access to vaginal breech birth is important for some women; however, this choice may be challenging to achieve. Consistent information and support from clinicians is important to assist decision-making.

Women's experiences of planning a vaginal breech birth in Australia.

BACKGROUND: In many countries, planned vaginal breech birth (VBB) is a rare event. After the Term Breech Trial in 2000, VBB reduced and caesarean section for breech presentation increased. Despite this, women still request VBB. The objective of this study was to explore the experiences and decision-making processes of women who had sought a VBB. METHODS: A qualitative study using descriptive exploratory design was undertaken. Twenty-two (n = 22) women who planned a VBB, regardless of eventual mode of birth were recruited. The women had given birth at one of two maternity hospitals in Australia that supported VBB. In-depth, semi-structured interviews using an interview guide were conducted. Interviews were analysed thematically. RESULTS: Twenty two women were interviewed; three quarters were primiparous (n = 16; 73%). Nine (41%) were already attending a hospital that supported VBB with the remaining women moving hospitals. All women actively sought a vaginal breech birth because the baby remained breech after an external cephalic version - 12 had a vaginal birth (55%) and 10 (45%) a caesarean section after labour commenced. There were four main themes: Reacting to a loss of choice and control, Wanting information that was trustworthy, Fighting the system and seeking support for VBB and The importance of 'having a go' at VBB. CONCLUSIONS: Women seeking a VBB value clear, consistent and relevant information in deciding about mode of birth. Women desire autonomy to choose vaginal breech birth and to be supported in their choice with high quality care.

Caseload midwifery care versus standard maternity care for women of any risk: M@NGO, a randomised controlled trial.

BACKGROUND: Women at low risk of pregnancy complications benefit from continuity of midwifery care, but no trial evidence exists for women with identified risk factors. We aimed to assess the clinical and cost outcomes of caseload midwifery care for women irrespective of risk factors. METHODS: In this unblinded, randomised, controlled, parallel-group trial, pregnant women at two metropolitan teaching hospitals in Australia were randomly assigned to either caseload midwifery care or standard maternity care by a telephone-based computer randomisation service. Women aged 18 years and older were eligible if they were less than 24 weeks pregnant at the first booking visit. Those who booked with another care provider, had a multiple pregnancy, or planned to have an elective caesarean section were excluded. Women allocated to caseload care received antenatal, intrapartum, and postnatal care from a named caseload midwife (or back-up caseload midwife). Controls received standard care with rostered midwives in discrete wards or clinics. The participant and the clinician were not masked to assignment. The main primary outcome was the proportion of women who had a caesarean section. The other primary maternal outcomes were the proportions who had an instrumental or unassisted vaginal birth, and the proportion who had epidural analgesia during labour. Primary neonatal outcomes were Apgar scores, preterm birth, and admission to neonatal intensive care. We analysed all outcomes by intention to treat. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000349246. FINDINGS: Publicly insured women were screened at the participating hospitals between Dec 8, 2008, and May 31, 2011. 1748 pregnant women were randomly assigned, 871 to caseload and 877 to standard care. The proportion of caesarean sections did not differ between the groups (183 [21%] in the caseload group vs 204 [23%] in the standard care group; odds ratio [OR] 0·88, 95% CI 0·70-1·10; p=0·26). The proportion of women who had elective caesarean sections (before onset of labour) differed significantly between caseload and standard care (69 [8%] vs 94 [11%]; OR 0·72, 95% CI 0·52-0·99; p=0·05). Proportions of instrumental birth were similar (172 [20%] vs 171 [19%]; p=0·90), as were the proportions of unassisted vaginal births (487 [56%] vs 454 [52%]; p=0·08) and epidural use (314 [36%] vs 304 [35%]; p=0·54). Neonatal outcomes did not differ between the groups. Total cost of care per woman was AUS$566·74 (95% 106·17-1027·30; p=0·02) less for caseload midwifery than for standard maternity care. INTERPRETATION: Our results show that for women of any risk, caseload midwifery is safe and cost effective. FUNDING: National Health and Medical Research Council (Australia).

Does pregnancy and/or shifting positions create more room in a woman's pelvis?

OBJECTIVE: The purpose of this study was to assess the impact of different positions on pelvic diameters by comparing pregnant and nonpregnant women who assumed a dorsal supine and kneeling squat position. STUDY DESIGN: In this cohort study from a tertiary referral center in Germany, we enrolled 50 pregnant women and 50 nonpregnant women. Pelvic measurements were obtained with obstetric magnetic resonance imaging pelvimetry with the use of a 1.5-T scanner. We compared measurements of the depth (anteroposterior (AP) and width (transverse diameters) of the pelvis between the 2 positions. RESULTS: The most striking finding was a significant 0.9-1.9 cm increase (7-15%) in the average transverse diameters in the kneeling squat position in both pregnant and nonpregnant groups. The average bispinous diameter in the pregnant group increased from 12.6 cm ± 0.65 cm in the supine dorsal to 14.5 cm ± 0.64 cm (P < .0001) in the kneeling squat; in the nonpregnant group the increase was from 12 cm ± 0.76 cm to 13.9 cm ± 1.04 cm (P < .0001). The average bituberous diameter in the pregnant group increased from 13.6 cm ± 0.93 cm in the supine dorsal to 14.5 cm ± 0.83 cm (P < .0001) in the kneeling squat position; in the nonpregnant women the increase was from 12.6 cm ± 0.92 cm to 13.5 cm ± 0.88 cm (P < .0001). CONCLUSION: A kneeling squat position significantly increases the bony transverse and anteroposterior dimension in the mid pelvic plane and the pelvic outlet. Because this indicates that pelvic diameters change when women change positions, the potential for facilitation of delivery of the fetal head suggests further research that will compare maternal delivery positions is warranted.

Caseload midwifery compared to standard or private obstetric care for first time mothers in a public teaching hospital in Australia: a cross sectional study of cost and birth outcomes.

BACKGROUND: In many countries midwives act as the main providers of care for women throughout pregnancy, labour and birth. In our large public teaching hospital in Australia we restructured the way midwifery care is offered and introduced caseload midwifery for one third of women booked at the hospital. We then compared the costs and birth outcomes associated with caseload midwifery compared to the two existing models of care, standard hospital care and private obstetric care. METHODS: We undertook a cross sectional study examining the risk profile, birth outcomes and cost of care for women booked into one of the three available models of care in a tertiary teaching hospital in Australia between July 1st 2009 December 31st 2010. To control for differences in population or case mix we described the outcomes for a cohort of low risk first time mothers known as the 'standard primipara'. RESULTS: Amongst the 1,379 women defined as 'standard primipara' there were significant differences in birth outcome. These first time 'low risk' mothers who received caseload care were more likely to have a spontaneous onset of labour and an unassisted vaginal birth 58.5% in MGP compared to 48.2% for Standard hospital care and 30.8% with Private obstetric care (p < 0.001). They were also significantly less likely to have an elective caesarean section 1.6% with MGP versus 5.3% with Standard care and 17.2% with private obstetric care (p < 0.001). From the public hospital perspective, over one financial year the average cost of care for the standard primipara in MGP was $3903.78 per woman. This was $1375.45 less per woman than those receiving Private obstetric care and $1590.91 less than Standard hospital care per woman (p < 0.001). Similar differences in cost were found in favour of MGP for all women in the study who received caseload care. CONCLUSIONS: Cost reduction appears to be achieved through reorganising the way care is delivered in the public hospital system with the introduction of Midwifery Group Practice or caseload care. The study also highlights the unexplained clinical variation that exists between the three models of care in Australia.

Lessons to be learnt in managing the breech presentation at term: an 11-year single-centre retrospective study.

BACKGROUND: The 2000 publication of the Term Breech Trial significantly impacted obstetric practice in Australia with a rapid increase in delivery of term breech singletons by caesarean section. More reassuring data from European centres who continued to offer vaginal breech deliveries to carefully selected women have led to a softening of international guidelines which now support an individualised approach to management. The application of this principle to an Australian population, particularly in the wake of such a major change in obstetric practice, has not previously been demonstrated. AIM: To compare short-term neonatal and maternal morbidity for infants with a singleton breech presentation born after 37 weeks, according to planned mode of delivery. MATERIALS AND METHODS: Eleven-year single-centre retrospective study with intention-to-treat analysis based on intended mode of delivery. RESULTS: Two hundred and forty-three of 766 (31.7%) eligible women elected for planned vaginal breech delivery. The overall success rate in this group was 58%. Morbidity rates were low and compare favourably with similar international studies. However, there was a nonsignificant trend towards higher rates of short-term serious neonatal and maternal morbidity in the planned vaginal delivery group (1.6 vs 0.4%, P = 0.08 and 8.2 vs 4.8%, P = 0.06, respectively). CONCLUSIONS: Attempted vaginal delivery for breech presentation remains an option in carefully selected women under strict obstetric protocols.

Moxibustion for cephalic version: a feasibility randomised controlled trial.

BACKGROUND: Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. METHODS: The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound), were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. RESULTS: Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5) was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to increase women's choices, and explore opportunities to normalise birth. The sample size for a future trial is estimated to be 381 women. CONCLUSION: Our findings should be interpreted with caution as the study was underpowered to detect statistical differences between groups. Acceptance by women and health professionals towards moxibustion suggest further research is warranted. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000985280.

Intrapartum interventions and outcomes for women and children following induction of labour at term in uncomplicated pregnancies: a 16-year population-based linked data study.

OBJECTIVES: We compared intrapartum interventions and outcomes for mothers, neonates and children up to 16 years, for induction of labour (IOL) versus spontaneous labour onset in uncomplicated term pregnancies with live births. DESIGN: We used population linked data from New South Wales, Australia (2001-2016) for healthy women giving birth at 37+0 to 41+6 weeks. Descriptive statistics and logistic regression were performed for intrapartum interventions, postnatal maternal and neonatal outcomes, and long-term child outcomes adjusted for maternal age, country of birth, socioeconomic status, parity and gestational age. RESULTS: Of 474 652 included births, 69 397 (15%) had an IOL for non-medical reasons. Primiparous women with IOL versus spontaneous onset differed significantly for: spontaneous vaginal birth (42.7% vs 62.3%), instrumental birth (28.0% vs 23.9%%), intrapartum caesarean section (29.3% vs 13.8%), epidural (71.0% vs 41.3%), episiotomy (41.2% vs 30.5%) and postpartum haemorrhage (2.4% vs 1.5%). There was a similar trend in outcomes for multiparous women, except for caesarean section which was lower (5.3% vs 6.2%). For both groups, third and fourth degree perineal tears were lower overall in the IOL group: primiparous women (4.2% vs 4.9%), multiparous women (0.7% vs 1.2%), though overall vaginal repair was higher (89.3% vs 84.3%). Following induction, incidences of neonatal birth trauma, resuscitation and respiratory disorders were higher, as were admissions to hospital for infections (ear, nose, throat, respiratory and sepsis) up to 16 years. There was no difference in hospitalisation for asthma or eczema, or for neonatal death (0.06% vs 0.08%), or in total deaths up to 16 years. CONCLUSION: IOL for non-medical reasons was associated with higher birth interventions, particularly in primiparous women, and more adverse maternal, neonatal and child outcomes for most variables assessed. The size of effect varied by parity and gestational age, making these important considerations when informing women about the risks and benefits of IOL.

Harnessing technology to enable all women mobility in labour and birth: feasibility of implementing beltless non-invasive fetal ECG applying the NASSS framework.

BACKGROUND: A new wireless and beltless monitoring device utilising fetal and maternal electrocardiography (ECG) and uterine electromyography, known as 'non-invasive fetal ECG' (NIFECG) was registered for clinical use in Australia in 2018. The safety and reliability of NIFECG has been demonstrated in controlled settings for short periods during labour. As far as we are aware, at the time our study commenced, this was globally the first trial of such a device in an authentic clinical setting for the entire duration of a woman's labour. METHODS: This study aimed to assess the feasibility of using NIFECG fetal monitoring for women undergoing continuous electronic fetal monitoring during labour and birth. Women were eligible to participate in the study if they were at 36 weeks gestation or greater with a singleton pregnancy, planning to give birth vaginally and with obstetric indications as per local protocol (NSW Health Fetal Heart Rate Monitoring Guideline GL2018_025. 2018) for continuous intrapartum fetal monitoring. Written informed consent was received from participating women in antenatal clinic prior to the onset of labour. This single site clinical feasibility study took place between January and July 2020 at the Royal Hospital for Women in Sydney, Australia. Quantitative and qualitative data were collected to inform the analysis of results using the NASSS (Non-adoption, Abandonment, Scale up, Spread and Sustainability) framework, a validated tool for analysing the implementation of new health technologies into clinical settings. RESULTS: Women responded positively about the comfort and freedom of movement afforded by the NIFECG. Midwives reported that when no loss of contact occurred, the device enabled them to focus less on the technology and more on supporting women's physical and emotional needs during labour. Midwives and obstetricians noticed the benefits for women but expressed a need for greater certainty about the reliability of the signal. CONCLUSION: The NIFECG device enables freedom of movement and positioning for labouring women and was well received by women and the majority of clinicians. Whilst measurement of the uterine activity was reliable, there was uncertainty for clinicians in relation to loss of contact of the fetal heart rate. If this can be ameliorated the device shows potential to be used as routinely as cardiotocography (CTG) for fetal monitoring. This is the first time the NASSS framework has been used to synthesise the implementation needs of a health technology in the care of women during labour and birth. Our findings contribute new knowledge about the determinants for implementation of a complex technology in a maternity care setting. TRIAL REGISTRATION: The Universal Trial Number is reU1111-1228-9845 and the Australian and New Zealand Clinical Trial Registration Number is 12619000293167p. Trial registration occurred on the 20 February, 2019. The trial protocol may be viewed at http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377027.

Persistent occiput posterior position outcomes following manual rotation: a randomized controlled trial.

BACKGROUND: Persistent occiput posterior position in labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation from the occiput posterior position to the occiput anterior position in the second stage of labor is considered a safe and easy to perform procedure that in observational studies has shown promise as a method for preventing operative deliveries. OBJECTIVE: This study aimed to determine the efficacy of prophylactic manual rotation in the management of occiput posterior position for preventing operative delivery. The hypothesis was that among women who are at least 37 weeks pregnant and whose baby is in the occiput posterior position early in the second stage of labor, manual rotation will reduce the rate of operative delivery compared with the "sham" rotation. STUDY DESIGN: A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 4 tertiary hospitals was conducted in Australia. A total of 254 nulliparous and parous women with a term pregnancy and a baby in the occiput posterior position in the second stage of labor were randomly assigned to receive either a prophylactic manual rotation (n=127) or a sham rotation (n=127). The primary outcome was operative delivery (cesarean, forceps, or vacuum delivery). Secondary outcomes were cesarean delivery, combined maternal mortality and serious morbidity, and combined perinatal mortality and serious morbidity. Analysis was by intention to treat. Proportions were compared using chi-square tests adjusted for stratification variables using the Mantel-Haenszel method or the Fisher exact test. Planned subgroup analyses by operator experience and by manual rotation technique (digital or whole-hand rotation) were performed. RESULTS: Operative delivery occurred in 79 of 127 women (62%) assigned to prophylactic manual rotation and 90 of 127 women (71%) assigned to sham rotation (common risk difference, 12; 95% confidence interval, -1.7 to 26; P=.09). Among more experienced operators or investigators, operative delivery occurred in 46 of 74 women (62%) assigned to manual rotation and 52 of 71 women (73%) assigned to a sham rotation (common risk difference, 18; 95% confidence interval, -0.5 to 36; P=.07). Cesarean delivery occurred in 22 of 127 women (17%) in both groups. Instrumental delivery (forceps or vacuum) occurred in 57 of 127 women (45%) assigned to prophylactic manual rotation and 68 of 127 women (54%) assigned to sham rotation (common risk difference, 10; 95% confidence interval, -3.1 to 22; P=.14). There was no significant difference in the combined maternal and perinatal outcomes. CONCLUSION: Prophylactic manual rotation did not result in a reduction in the rate of operative delivery. Given manual rotation was associated with a nonsignificant reduction in operative delivery, more randomized trials are needed, as our trial might have been underpowered. In addition, further research is required to further explore the potential impact of operator or investigator experience.