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AbstractObjectivesTo investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions.DesignPragmatic, multicentre, stepped wedge cluster randomised trial.Setting60 midwifery practices in the Netherlands.Participants13 046 women aged 16 years or older with a low risk singleton pregnancy.Interventions60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks’ gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies.Main outcome measuresThe primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth.ResultsBetween 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks’ gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies.ConclusionIn low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies.Trial registrationNetherlands Trial Register NTR4367.

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. 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. 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. Our results show that for women of any risk, caseload midwifery is safe and cost effective. National Health and Medical Research Council (Australia).

Background Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women’s satisfaction with care across the maternity continuum. Methods Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating. Results Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88 % in the caseload group and 74 % in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95 % CI 2.79, 4.03), intrapartum care (OR 2.14; 95 % CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95 % CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95 % CI 2.64, 3.85). Conclusion For women at low risk of medical complications, caseload midwifery increases women’s satisfaction with antenatal, intrapartum and postpartum care. Trial registration Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007).

Pelvic organ prolapse (POP) is a common condition that can significantly impact a woman's quality of life. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment for prolapse, but evidence on its effectiveness from low-resource settings is limited. This study aimed to assess the effect of midwife-led PFMT on prolapse symptoms and health-related quality of life (HRQoL) among women with mild-to-moderate POP in Ethiopia. A community-based, parallel-groups, two-arm cluster-randomized controlled trial was conducted in Dale and Wonsho districts of Sidama Region, Ethiopia. Women with symptomatic POP stages I-III were randomized by cluster to receive either midwife-led PFMT plus lifestyle counseling (intervention group) or lifestyle counseling alone (control group). The participants and counselors knew what the women were receiving, but they were not aware of the other group. The outcome assessors, who collected data at the end of intervention, were blinded to the participants' treatment allocation. The primary outcomes were changes in prolapse symptom score (POP-SS) and prolapse quality of life (P-QoL). Mixed-effects generalized linear model was used to determine the effect of PFMT on prolapse symptoms and P-QoL at 99% confidence level. Adjusted β coefficients were used as effect measures. The level of significance was adjusted for multiple comparisons. A total of 187 women were randomized to intervention (n = 86) from four clusters and control (n = 101) arms from another four clusters. At sixth months, the intervention group showed significantly greater improvements both in prolapse symptoms and P-QoL. The mean change difference in POP-SS was -4.11 (99% CI [-5.38, -2.83]; p <  0.001). Similarly, the mean change difference was: -8.86 (99% CI [-13.84, -3.89]; p < 0.001) in physical domain of P-QoL; -11.18 (99% CI [-15.03, -7.32]; p < 0.001) in psychological domain of P-QoL, and -9.01 (99% CI [-10.49, -5.54]; p < 0.001) in personal relationship domain of P-QoL. A significantly higher proportion (83.72%) of women in the intervention group perceived their condition as \"better\" after the intervention as compared to 41.58% in the control group. Women with earlier stages of prolapse (stages I and II) experienced higher benefits compared to those in stage III. A midwife-led PFMT combined with lifestyle counseling significantly improves prolapse symptoms and quality of life in mild-to-moderate POP. This strategy can be integrated into the existing maternal and reproductive health programs to address POP in low-income settings where access to trained specialist is limited. The trial was registered at the Pan African Clinical Trial Registry (https://pactr.samrc.ac.za) database, with the registration number PACTR202302505126575 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24311).

This study investigated the feasibility and preliminary effects of enhanced midwifery care in reducing subclinical depression symptoms among women in ethnically diverse areas of the South Western Sydney Local Health District (SWSLHD). A pilot randomised controlled trial was conducted among pregnant women attending the Fairfield and/or Liverpool antenatal clinic with an Edinburgh Depression Scale (EDS) score of 10-12 (i.e., just below the generally accepted clinical cut-off score of 13 to indicate subclinical depressive symptoms) during the first antenatal visit (i.e., before 26 weeks gestation). Participants were randomly allocated to either the intervention group which received continuous and coordinated support from a dedicated Registered Midwife (RM) trained in counselling and linked with a multidisciplinary team, or the usual care group, which received standard maternity care from various providers without continuity or additional coordinated support. Primary outcomes included feasibility of recruitment, randomisation, intervention delivery and fidelity, and retention and follow-up. The secondary outcomes were improvement in depressive symptom severity assessed via EDS, psychological distress (Kessler's psychological distress scale-K10), and parenting confidence (Karitane Parenting Confidence Scale (KPCS). Descriptive analyses were used to assess the feasibility outcomes, whereas mixed-effects models were used to examine the effects of treatment on secondary outcomes. Thirty-seven mothers were recruited into the study, of which eighteen were randomised to the intervention group and nineteen to the usual care group. The intervention was delivered with good fidelity, and remote adaptations during COVID-19 ensured both continuity of care and high retention at 6-month follow-up. Findings of the mixed-effects models showed significant within-group reduction in EDS scores over time, with scores at 8 weeks postpartum (T2) significantly lower than at baseline (T0; β = -2.77, SE = 1.36, < 0.05) but no significant differences between the groups (β = -0.02, SE = 1.63, = 0.992) or time-by-group interactions at any timepoint for EDS, K10, and KPCS. These findings demonstrate the feasibility of enhanced midwifery care in a \"hard to reach\" population of SWSLHD and highlight the need for adequately powered trials to determine its effectiveness on maternal mental health and parenting outcomes.

ObjectivesTo assess the feasibility of an intervention of midwifery support for antenatal pelvic floor muscle exercises (PFME) to prevent postnatal urinary incontinence (UI).DesignFeasibility and pilot cluster randomised controlled trial. Clusters were community midwifery teams.SettingCommunity maternity antenatal care.ParticipantsOne hundred seventy-five women; 186 midwives.InterventionMidwifery training and resources for midwives and women to support antenatal PFME. Control clusters continued standard care.OutcomesWomen reporting: that their midwife explained how to do PFME, PFME adherence and postpartum UI. Midwives reporting: pre-post-training PFME confidence, intervention acceptability. Fidelity of training delivery and implementation.ResultsNinety-five midwives in intervention clusters; 91 midwives in control clusters. Of 998 women sent questionnaires, 175 responded: 15.8% in intervention, 16.4% in control clusters. Women’s characteristics in both trial arms were similar and characteristics of respondents and non-respondents were similar. Sixty-five percent (95% CI 56.9% to 72.4%) of women in intervention clusters reported their midwife explained how to do PFME vs 38% (95% CI 24.6% to 51.2%) in control clusters. Fifty percent (95% CI 24.1% to 77.1%) of women in intervention clusters vs 38% (95% CI 12.4% to 67.1%) in control clusters reported doing enough PFME to potentially prevent UI. Fourty-four percent (95% CI 32.0% to 56.1%) of women in intervention clusters reported UI vs 54% (95% CI 42.2% to 65.8%) in control clusters.Intervention training was delivered with fidelity and received positively. Midwives reported improvements in PFME confidence/knowledge (median increase of at least 1 point on a 0–4 scale for each of eight questions). Midwives (26%) most frequently reported insufficient time as an implementation barrier.ConclusionsThis pilot trial produced consistent new findings that training and resourcing midwives to teach and support pregnant women to undertake PFME is acceptable and feasible for women and midwives. It increased the number of women who are informed about PFME, with potential to improve PFME adherence and reduce postpartum UI. Recent changes to the National Health Service perinatal pelvic healthcare means a full trial is not possible.Trial registration numberISRCTN10833250.

Adolescent pregnancy is associated with elevated stress, anxiety, and depression, often exacerbated by limited social support. Despite the recognized risks faced by pregnant adolescents, there is a paucity of research evaluating the effectiveness of psychoeducational interventions specifically integrated into antenatal care for this population. Midwife-led care is widely recognized for its holistic and personalized approach, which is particularly valuable for adolescent mothers. Psychoeducational interventions, enhancements have shown promise in reducing psychological distress and improving well-being among pregnant adolescents. However, evidence remains limited, with few randomized controlled trials evaluating the impact of these interventions when delivered as part of routine childbirth preparation classes. This study aimed to assess the effect of a midwife-led psychoeducational life skills intervention, incorporated into routine childbirth preparation classes, on pregnancy-related anxiety, stress, depression, and perceived social support in pregnant adolescents. This randomized controlled trial involved 90 pregnant adolescents recruited from health centers, with 45 participants assigned to the intervention group and 45 to the control group. The intervention group received ten structured psychoeducational sessions focusing on life skills, delivered by a trained instructor alongside standard childbirth preparation classes. The control group received only routine prenatal education. The control group received routine care only. Outcome assessors were blinded to group allocation. Primary outcomes were pregnancy-related anxiety, perceived stress, and depression; the secondary outcome was perceived social support. Data were collected using validated self-report measures at three time points: baseline (pre-intervention), immediately post-intervention, and one month after the intervention. Statistical analyses were performed using SPSS version 22, including repeated-measures analysis of variance (ANOVA), independent t-tests, and chi-square tests. Ethical approval: IR.AJUMS.REC.1402.140. Trial registration: IRCT20190129042544N1 (26 June 2023). Compared with controls, the intervention group demonstrated significant reductions in anxiety (η² = 0.32, p  < 0.001), perceived stress (η² = 0.29, p  < 0.001), and depression (η² = 0.31, p  < 0.001). Perceived social support increased within both groups, but between-group differences were not significant ( p  = 0.238). The group × time interaction was statistically significant for anxiety, stress, and depression, compared with the control group, and this effect was maintained at both the 1-month and 3-month follow-up assessments, indicating the sustained efficacy of the midwife-led psychoeducational life skills program. The integration of a psychoeducational life skills program into routine midwife-led antenatal education proved effective in improving the psychological well-being of pregnant adolescents, as evidenced by significant reductions in anxiety, stress, and depression. These findings support the inclusion of structured psychoeducational interventions in adolescent maternity care services to promote mental health during pregnancy. While both the intervention and control groups experienced increased perceived social support, the lack of a significant between-group difference suggests that additional or alternative strategies may be needed to further enhance social support outcomes in this population. Trial registration : The study protocol was prospectively registered in the Iranian Registry for Randomized Controlled Trials on 26 June 2023 (registration number: IRCT20190129042544N1), and participant recruitment began on October 1, 2024.

Background High levels of childbirth fear impact birth preparation, obstetric outcomes and emotional wellbeing for around one in five women living in developed countries. Higher rates of obstetric intervention and caesarean section (CS) are experienced in fearful women. The efficacy of interventions to reduce childbirth fear is unclear, with no previous randomised controlled trials reporting birth outcomes or postnatal psychological wellbeing following a midwife led intervention. Method Between May 2012 and June 2013 women in their second trimester of pregnancy were recruited. Women with a fear score ≥ 66 on the Wijma Delivery Expectancy / Experience Questionnaire (W-DEQ) were randomised to receive telephone psycho-education by a midwife, or usual maternity care. A two armed non-blinded parallel (1:1) multi-site randomised controlled trial with participants allocated in blocks of ten and stratified by hospital site and parity using an electronic centralised computer service. The outcomes of the RCT on obstetric outcomes, maternal psychological well-being, parenting confidence, birth satisfaction, and future birth preference were analysed by intention to treat and reported here. Results 1410 women were screened for high childbirth fear (W-DEQ ≥66). Three hundred and thirty-nine ( n  = 339) women were randomised (intervention n  = 170; controls n  = 169). One hundred and eighty-four women (54 %) returned data for final analysis at 6 weeks postpartum (intervention n  = 91; controls n  = 93). Compared to controls the intervention group had a clinically meaningful but not statistically significant reduction in overall caesarean section (34 % vs 42 %, p  = 0.27) and emergency CS rates (18 % vs 25 %, p  = 0.23). Fewer women in the intervention group preferred caesarean section for a future pregnancy (18 % vs 30 %, p  = 0.04). All other obstetric variables remained similar. There were no differences in postnatal depression symptoms scores, parenting confidence, or satisfaction with maternity care between groups, but a lower incidence of flashbacks about their birth in the intervention group compared to controls (14 % vs 26 %, p  = 0.05). Postnatally women who received psycho-education reported that the ‘decision aid’ helped reduce their fear (53 % vs 37 %, p  = 0.02). Conclusion Following a brief antenatal midwife-led psycho-education intervention for childbirth fear women were less likely to experience distressing flashbacks of birth and preferred a normal birth in a future pregnancy. A reduction in overall CS rates was also found. Psycho-education for fearful women has clinical benefits for the current birth and expectations of future pregnancies. Trial registration Australian New Zealand Controlled Trials Registry ACTRN12612000526875 , 17th May 2012

Trial design A randomised, parallel group, pragmatic trial. Setting A large UK maternity hospital. Participants Term infants <2 weeks old with a mild or moderate degree of tongue-tie, and their mothers who were having difficulties breastfeeding. Objectives To determine if immediate frenotomy was better than standard breastfeeding support. Interventions Participants were randomised to an early frenotomy intervention group or a ‘standard care’ comparison group. Outcomes Primary outcome was breastfeeding at 5 days, with secondary outcomes of breastfeeding self-efficacy and pain on feeding. Final assessment was at 8 weeks; 20 also had qualitative interviews. Researchers assessing outcomes, but not participants, were blinded to group assignment. Results 107 infants were randomised, 55 to the intervention group and 52 to the comparison group. Five-day outcome measures were available for 53 (96%) of the intervention group and 52 (100%) of the comparison group, and intention-to-treat analysis showed no difference in the primary outcome—Latch, Audible swallowing, nipple Type, Comfort, Hold score. Frenotomy did improve the tongue-tie and increased maternal breastfeeding self-efficacy. At 5 days, there was a 15.5% increase in bottle feeding in the comparison group compared with a 7.5% increase in the intervention group. After the 5-day clinic, 44 of the comparison group had requested a frenotomy; by 8 weeks only 6 (12%) were breastfeeding without a frenotomy. At 8 weeks, there were no differences between groups in the breastfeeding measures or in the infant weight. No adverse events were observed. Conclusions Early frenotomy did not result in an objective improvement in breastfeeding but was associated with improved self-efficacy. The majority in the comparison arm opted for the intervention after 5 days.

Background This study investigated the effectiveness of brief midwife-led counseling based on Gamble and colleagues’ approach in decreasing post-traumatic stress disorder, depression, and anxiety symptoms among a group of women who had experienced a traumatic childbirth. Methods From among 270 pregnant women screened to participate in the study, 90 women experienced a traumatic childbirth. They were randomly assigned into two groups: intervention ( n  = 45) and control group ( n  = 45). We did a face-to-face counseling session within 72 h after giving birth and a telephone counseling session four to 6 weeks after giving birth for the intervention group. The control group only received the postnatal routine care. The outcome measures were post-traumatic stress disorder, depression, and anxiety symptoms. Results At the three-month follow-up, the intervention group showed significantly higher improvement on post-traumatic stress disorder, depression, and anxiety symptoms compared to the control group. Conclusions Gamble and colleagues’ midwife-led brief counseling could be an effective approach to reduce psychological distress of women who have experienced a traumatic childbirth. Trial registration number IRCT201608285417N2 , Date of Registration: 2/21/2017.