Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention to improve maternal mental health in the peripartum: study protocol for a randomised controlled trial.

BACKGROUND: Perinatal women are highly vulnerable to developing mental health issues and particularly susceptible to a recurrence of psychiatric illness. Poor mental health during the perinatal period can have long-term impacts on the physical and psychiatric health of both mother and child. A potentially useful strategy to improve women's mental health is through a mobile application teaching mindfulness, an evidence-based technique helping individuals focus on the present moment. METHODS: A mixed method, prospective randomised controlled trial. The study group comprise women aged 18 years and over, who are attending the public and private maternity clinics at Mater Mothers' Hospital. A sample of 360 prenatal women will be randomised into the intervention group (with the use of the mindfulness app) or usual care. Participants will remain in the study for 11 months and will be assessed at four timepoints for changes in postnatal depression, mother-infant bonding, and quality of life. A cost-effectiveness evaluation will also be conducted using quality-adjusted life year (QALY) calculations. A random selection of intervention participants will be invited to attend focus groups to give feedback on the mindfulness app. DISCUSSION: Previous studies have found mindfulness interventions can reduce stress, anxiety, depression, and sleep disturbances in a prenatal population. The risks of the intervention are low, but could be of significant benefit for women who are unable to attend face-to-face appointments due to geographical, financial, or time barriers; during endemic or pandemic scenarios; or due to health or mobility issues. TRIAL REGISTRATION: This study was approved by the Mater Misericordiae Human Research Ethics Committee (83,589). Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001581752 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385107&isReview=true ). Registered on 22 Dec. 2022.

Is a randomized controlled trial of waterbirth possible? An Australian feasibility study.

BACKGROUND: The safety of waterbirth is contested because of the lack of evidence from randomized trials and conflicting results. This research assessed the feasibility of a prospective study of waterbirth (trial or cohort). METHODS: We conducted a prospective cohort study at an Australian maternity hospital. Eligible women with uncomplicated pregnancies at 36 weeks of gestation were recruited and surveyed about their willingness for randomization. The primary midwife assessed waterbirth eligibility and intention on admission in labor, and onset of second stage. Primary outcomes measured feasibility. Intention-to-treat analysis, and per-protocol analysis, compared clinical outcomes of women and their babies who intended waterbirth and nonwaterbirth at onset of second stage. RESULTS: 1260 participants were recruited; 15% (n = 188) agreed to randomization in a future trial. 550 women were analyzed by intention-to-treat analysis: 351 (waterbirth) and 199 (nonwaterbirth). In per-protocol analysis, 14% (n = 48) were excluded. Women in the waterbirth group were less likely to have amniotomy and more likely to have water immersion and physiological third stage. There were no differences in other measures of maternal morbidity. There were no significant differences between groups for serious neonatal morbidity; four cord avulsions occurred in the waterbirth group with none in the landbirth group. An RCT would need approximately 6000 women to be approached at onset of second stage. CONCLUSIONS: A randomized trial of waterbirth compared with nonwaterbirth, powered to detect a difference in serious neonatal morbidity, is unlikely to be feasible. A powered prospective study with intention-to-treat analysis at onset of second stage is feasible.

Clinician's Attitudes to the Introduction of Routine Weighing in Pregnancy.

Background. Excessive gestational weight gain poses significant short- and long-term health risks to both mother and baby. Professional bodies and health services increasingly recommend greater attention be paid to weight gain in pregnancy. A large Australian tertiary maternity hospital plans to facilitate the (re)introduction of routine weighing of all women at every antenatal visit. Objective. To identify clinicians' perspectives of barriers and enablers to routinely weighing pregnant women and variations in current practice, knowledge, and attitudes between different staff groups. Method. Forty-four maternity staff from three professional groups were interviewed in four focus groups. Staff included midwives; medical staff; and dietitians. Transcripts underwent qualitative content analysis to identify and examine barriers and enablers to the routine weighing of women throughout pregnancy. Results. While most staff supported routine weighing, various concerns were raised. Issues included access to resources and staff; the ability to provide appropriate counselling and evidence-based interventions; and the impact of weighing on patients and the therapeutic relationship. Conclusion. Many clinicians supported the practice of routine weighing in pregnancy, but barriers were also identified. Implementation strategies will be tailored to the discrete professional groups and will address identified gaps in knowledge, resources, and clinician skills and confidence.

Women's, midwives' and obstetricians' experiences of a structured process to document refusal of recommended maternity care.

PROBLEM/BACKGROUND: Ethical and professional guidance for midwives and obstetricians emphasises informed consent and respect for patient autonomy; the right to refuse care is well established. However, the existing literature is largely silent on the appropriate clinical responses when pregnant women refuse recommended care, and accounts of disrespectful interactions and conflict are numerous. Policies and processes to support women and maternity care providers are rare and unstudied. AIM: To document the perspectives of women, midwives and obstetricians following the introduction of a structured process (Maternity Care Plan; MCP) to document refusal of recommended maternity care in a large tertiary maternity unit. METHODS: A qualitative, interpretive study involved thematic analysis of in-depth semi-structured interviews with women (n=9), midwives (n=12) and obstetricians (n=9). FINDINGS: Four major themes were identified including: 'Reassuring and supporting clinicians'; 'Keeping the door open'; 'Varied awareness, criteria and use of the MCP process' and 'No guarantees'. CONCLUSION: Clinicians felt protected and reassured by the structured documentation and communication process and valued keeping women engaged in hospital care. This, in turn, protected women's access to maternity care. However, the process could not guarantee favourable responses from other clinicians subsequently involved in the woman's care. Ongoing discussions of risk, perceived by women and some midwives to be pressure to consent to recommended care, were still evident. These limitations may have been attributable to the absence of agreed criteria for initiating the MCP process and fragmented care. Varying awareness and use of the process also diminished women's access to it.

Does preconception care work?

BACKGROUND: To date, there is a lack of evidence to suggest that a systematic and coordinated approach to prepregnancy care might make a difference. AIMS: To evaluate whether women who receive preconception care through a structured approach will be more likely to be healthy around the time of conception compared with women who plan their pregnancy but have not been exposed to preconception care. METHODS: A case control study was undertaken of women who attended the preconception care service and subsequently conceived, received maternity care and gave birth at Mater Health Services Brisbane between January 2010 and January 2013. Pregnancy information and birth outcomes for each woman who attended the service were matched with those of three women who reported that they had planned their pregnancy but did not attend the service. Records were matched for prepregnancy BMI, age, parity, prepregnancy smoking status and number of health conditions. RESULTS: Pregnant women who attended preconception care were more likely to have received adequate peri-conceptual folate, to report being vaccinated against influenza and hepatitis B, to have consulted with a specialist with the specific aim of optimising a pre-existing health condition and to report less weight gain up until booking. Preterm birth and hypertensive disorders of pregnancy were less common amongst women who had attended preconception care, and there were trends towards a decreased incidence of gestational diabetes, LGA and fetal anomalies. CONCLUSION: These preliminary data provide some optimism that a comprehensive preconception care service may positively influence maternal and neonatal outcomes.

Dietary supplements for preventing postnatal depression.

BACKGROUND: Postnatal depression is a medical condition that affects many women and the development of their infants. There is a lack of evidence for treatment and prevention strategies that are safe for mothers and infants. Certain dietary deficiencies in a pregnant or postnatal woman's diet may cause postnatal depression. By correcting these deficiencies postnatal depression could be prevented in some women. Specific examples of dietary supplements aimed at preventing postnatal depression include: omega-3 fatty acids, iron, folate, s-adenosyl-L-methionine, cobalamin, pyridoxine, riboflavin, vitamin D and calcium. OBJECTIVES: To assess the benefits of dietary supplements for preventing postnatal depression either in the antenatal period, postnatal period, or both. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). SELECTION CRITERIA: Randomised controlled trials, involving women who were pregnant or who had given birth in the previous six weeks, who were not depressed or taking antidepressants at the commencement of the trials. The trials could use as intervention any dietary supplementation alone or in combination with another treatment compared with any other preventive treatment, or placebo, or standard clinical care. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and assessed the risk of bias for the two included studies. Two review authors extracted data and the data were checked for accuracy. MAIN RESULTS: We included two randomised controlled trials.One trial compared oral 100 microgram (µg) selenium yeast tablets with placebo, taken from the first trimester until birth. The trial randomised 179 women but outcome data were only provided for 85 women. Eighty-three women were randomised to each arm of the trial. Sixty-one women completed the selenium arm, 44 of whom completed an Edinburgh Postnatal Depression Scale (EPDS). In the placebo arm, 64 women completed the trial, 41 of whom completed an EPDS. This included study (n = 85) found selenium had an effect on EPDS scores but did not reach statistical significance (P = 0.07). There was a mean difference (MD) of -1.90 (95% confidence interval (CI) -3.92 to 0.12) of the self-reported EPDS completed by participants within eight weeks of delivery. There was a high risk of attrition bias due to a large proportion of women withdrawing from the study or not completing an EPDS. This included study did not report on any of the secondary outcomes of this review.The other trial compared docosahexanoic acid (DHA) and eicosapentaenoic acid (EPA) with placebo. The trial randomised 126 women at risk of postpartum depression to three arms: 42 were allocated to EPA, 42 to DHA, and 42 to placebo. Three women in the EPA arm, four in the DHA arm, and one woman in the placebo arm were lost to follow-up. Women who were found to have major depressive disorder, bipolar disorder, current substance abuse or dependence, suicidal ideation or schizophrenia at recruitment were excluded from the study. The women who discontinued the intervention (five in the EPA arm, four in the DHA arm and seven in the placebo arm) were included in the intention-to-treat analysis, while those who were lost to follow-up were not. Women received supplements or placebo from recruitment at a gestational age of 12 to 20 weeks until their final review visit six to eight weeks postpartum. The primary outcome measure was the Beck Depression Inventory (BDI) score at the fifth visit (six to eight weeks postpartum). No benefit was found for EPA-rich fish oil (MD 0.70, 95% CI -1.78 to 3.18) or DHA-rich fish oil supplementation (MD 0.90, 95% CI -1.33 to 3.13) in preventing postpartum depression. No difference was found in the effect on postnatal depression comparing EPA with DHA (MD -0.20, 95% CI -2.61 to 2.21). No benefit or significant effect was found in terms of the secondary outcomes of the presence of major depressive disorder at six to eight weeks postpartum, the number of women who commenced antidepressants, maternal estimated blood loss at delivery or admission of neonates to the neonatal intensive care unit. AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude that selenium, DHA or EPA prevent postnatal depression. There is currently no evidence to recommend any other dietary supplement for prevention of postnatal depression.

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).

Antenatal perineal massage for reducing perineal trauma.

BACKGROUND: Perineal trauma following vaginal birth can be associated with significant short-term and long-term morbidity. Antenatal perineal massage has been proposed as one method of decreasing the incidence of perineal trauma. OBJECTIVES: To assess the effect of antenatal digital perineal massage on the incidence of perineal trauma at birth and subsequent morbidity. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (22 October 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2012, Issue 10), PubMed (1966 to October 2012), EMBASE (1980 to October 2012) and reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials evaluating any described method of antenatal digital perineal massage undertaken for at least the last four weeks of pregnancy. DATA COLLECTION AND ANALYSIS: Both review authors independently applied the selection criteria, extracted data from the included studies and assessed study quality. We contacted study authors for additional information. MAIN RESULTS: We included four trials (2497 women) comparing digital perineal massage with control. All were of good quality. Antenatal digital perineal massage was associated with an overall reduction in the incidence of trauma requiring suturing (four trials, 2480 women, risk ratio (RR) 0.91 (95% confidence interval (CI) 0.86 to 0.96), number needed to treat to benefit (NNTB) 15 (10 to 36)) and women practicing perineal massage were less likely to have an episiotomy (four trials, 2480 women, RR 0.84 (95% CI 0.74 to 0.95), NNTB 21 (12 to 75)). These findings were significant for women without previous vaginal birth only. No differences were seen in the incidence of first- or second-degree perineal tears or third-/fourth-degree perineal trauma. Only women who have previously birthed vaginally reported a statistically significant reduction in the incidence of pain at three months postpartum (one trial, 376 women, RR 0.45 (95% CI 0.24 to 0.87) NNTB 13 (7 to 60)). No significant differences were observed in the incidence of instrumental deliveries, sexual satisfaction, or incontinence of urine, faeces or flatus for any women who practised perineal massage compared with those who did not massage. AUTHORS' CONCLUSIONS: Antenatal digital perineal massage reduces the likelihood of perineal trauma (mainly episiotomies) and the reporting of ongoing perineal pain, and is generally well accepted by women. As such, women should be made aware of the likely benefit of perineal massage and provided with information on how to massage.

Midwifery group practice and mode of birth.

BACKGROUND: Midwifery-led models of care, specifically Midwifery Group Practices (MGPs), have been promoted as one way to address the increasing caesarean rate. Whilst women report a high level of satisfaction, and experience lower rates of induction and epidural analgesia, a Cochrane review reported no differences in mode of birth. METHOD: A retrospective cohort study was performed using routinely collected de-identified data of all term births between 2006 and 2010. Outcomes for 1545 women under MGP model were compared with 13,880 women cared for in all other models. Primary outcome measure was unassisted vaginal birth. Predictors investigated were model of care, induction and epidural analgesia. Both bivariate analysis and multivariate logistic regression analysis was undertaken (controlling for important confounders) with adjusted odds ratios (aOR) and 95% confidence intervals (CI) presented. FINDINGS: Significant differences were demonstrated in the demographic and clinical characteristics of the groups. Compared with those in other models of care, women in MGP care had similar rates of induction but significantly fewer received epidural analgesia (28.4% vs 33.5%; p<0.001). There was no difference in the mode of birth. When adjusted for confounders, women in MGP care were no more or less likely to have an unassisted vaginal birth (aOR 1.07; 95% CI 0.92-1.24; p=0.397), birth assisted by instrument (aOR 1.02; 95% CI 0.86-1.21; p=0.852) or emergency caesarean section (aOR 0.89; 95% CI 0.74-1.06; p=0.193). However, in the subgroup of women who did not receive epidural analgesia, women in MGP care had an increased likelihood of an unassisted vaginal birth (aOR 1.29; 95% CI 1.06-1.58; p=0.013). CONCLUSION: Women in MGP care are no more or less likely to have an unassisted vaginal birth.