LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial.

INTRODUCTION: There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique. METHODS AND ANALYSIS: A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months' postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities. ETHICS AND DISSEMINATION: The study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021.We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE. TRIAL REGISTRATION NUMBER: ISRCTN14566195.

The impact of preoperative oral nutrition supplementation on outcomes in patients undergoing gastrointestinal surgery for cancer in low- and middle-income countries: a systematic review and meta-analysis.

Malnutrition is an independent predictor for postoperative complications in low- and middle-income countries (LMICs). We systematically reviewed evidence on the impact of preoperative oral nutrition supplementation (ONS) on patients undergoing gastrointestinal cancer surgery in LMICs. We searched EMBASE, Cochrane Library, Web of Science, Scopus, WHO Global Index Medicus, SciELO, Latin American and Caribbean Health Sciences Literature (LILACS) databases from inception to March 21, 2022 for randomised controlled trials evaluating preoperative ONS in gastrointestinal cancer within LMICs. We evaluated the impact of ONS on all postoperative outcomes using random-effects meta-analysis. Seven studies reported on 891 patients (446 ONS group, 445 control group) undergoing surgery for gastrointestinal cancer. Preoperative ONS reduced all cause postoperative surgical complications (risk ratio (RR) 0.53, 95% CI 0.46-0.60, P < 0.001, I2 = 0%, n = 891), infection (0.52, 0.40-0.67, P = 0.008, I2 = 0%, n = 570) and all-cause mortality (0.35, 0.26-0.47, P = 0.014, I2 = 0%, n = 588). Despite heterogeneous populations and baseline rates, absolute risk ratio (ARR) was reduced for all cause (pooled effect -0.14, -0.22 to -0.06, P = 0.006; number needed to treat (NNT) 7) and infectious complications (-0.13, -0.22 to -0.06, P < 0.001; NNT 8). Preoperative nutrition in patients undergoing gastrointestinal cancer surgery in LMICs demonstrated consistently strong and robust treatment effects across measured outcomes. However additional higher quality research, with particular focus within African populations, are urgently required.

A comparison of intrapartum interventions and adverse outcomes by parity in planned freestanding midwifery unit and alongside midwifery unit births: secondary analysis of 'low risk' births in the birthplace in England cohort.

BACKGROUND: For low risk women, there is good evidence that planned birth in a midwifery unit is associated with a reduced risk of maternal interventions compared with planned birth in an obstetric unit. Findings from the Birthplace cohort study have been interpreted by some as suggesting a reduced risk of interventions in planned births in freestanding midwifery units (FMUs) compared with planned births in alongside midwifery units (AMUs). However, possible differences have not been robustly investigated using individual-level Birthplace data. METHODS: This was a secondary analysis of data on 'low risk' women with singleton, term, 'booked' pregnancies collected in the Birthplace national prospective cohort study. We used logistic regression to compare interventions and outcomes by parity in 11,265 planned FMU births and 16,673 planned AMU births, adjusted for potential confounders, using planned AMU birth as the reference group. Outcomes considered included adverse perinatal outcomes (Birthplace primary outcome measure), instrumental delivery, intrapartum caesarean section, 'straightforward vaginal birth', third or fourth degree perineal trauma, blood transfusion and maternal admission for higher-level care. We used a significance level of 1% for all secondary outcomes. RESULTS: There was no significant difference in adverse perinatal outcomes between planned AMU and FMU births. The odds of instrumental delivery were reduced in planned FMU births (nulliparous: aOR 0.63, 99% CI 0.46-0.86; multiparous: aOR 0.41, 99% CI 0.25-0.68) and the odds of having a 'straightforward vaginal birth' were increased in planned FMU births compared with planned AMU births (nulliparous: aOR 1.47, 99% CI 1.17-1.85; multiparous: 1.86, 99% CI 1.35-2.57). The odds of intrapartum caesarean section did not differ significantly between the two settings (nulliparous: p = 0.147; multiparous: p = 0.224). The overall pattern of findings suggested a trend towards lower intervention rates and fewer adverse maternal outcomes in planned FMU births compared with planned AMU births. CONCLUSIONS: The findings support the recommendation that 'low risk' women can be informed that planned birth in an FMU is associated with a lower rate of instrumental delivery and a higher rate of 'straightforward vaginal birth' compared with planned birth in an AMU; and that outcomes for babies do not appear to differ between FMUs and AMUs.

A summary of the iodine supplementation study protocol (I2S2): a UK multicentre randomised controlled trial in preterm infants.

This paper summarises the study protocol for the randomised controlled trial of iodine supplementation in preterm infants. Iodine is essential for the synthesis of thyroxine, and thyroxine is essential for normal brain development in utero and for the first 2-3 years of life. The recommended iodine intake in parenteral nutrition regimens is 1 µg/kg/day and commercially available parenteral solutions for infants reflect these recommendations. In the absence of other iodine sources, infants are vulnerable to negative iodine balance and insufficiency. As many preterm infants are fed parenterally for prolonged periods with solutions which have been shown to be iodine-deficient, the I2S2 Trial was designed to establish whether iodine supplementation of preterm infants benefits neurodevelopment.

Duration and urgency of transfer in births planned at home and in freestanding midwifery units in England: secondary analysis of the birthplace national prospective cohort study.

BACKGROUND: In England, there is a policy of offering healthy women with straightforward pregnancies a choice of birth setting. Options may include home or a freestanding midwifery unit (FMU). Transfer rates from these settings are around 20%, and higher for nulliparous women. The duration of transfer is of interest because of the potential for delay in access to specialist care and is also of concern to women. We aimed to estimate the duration of transfer in births planned at home and in FMUs and explore the effects of distance and urgency on duration. METHODS: This was a secondary analysis of data collected in a national prospective cohort study including 27,842 'low risk' women with singleton, term, 'booked' pregnancies, planning birth in FMUs or at home in England from April 2008 to April 2010. We described transfer duration using the median and interquartile range, for all transfers and those for reasons defined as potentially urgent or non-urgent, and used cumulative distribution curves to compare transfer duration by urgency. We explored the effect of distance for transfers from FMUs and described outcomes in women giving birth within 60 minutes of transfer. RESULTS: The median overall transfer time, from decision to transfer to first OU assessment, was shorter in transfers from home compared with transfers from FMUs (49 vs 60 minutes; p < 0.001). The median duration of transfers before birth for potentially urgent reasons (home 42 minutes, FMU 50 minutes) was 8-10 minutes shorter compared with transfers for non-urgent reasons. In transfers for potentially urgent reasons, the median overall transfer time from FMUs within 20 km of an OU was 47 minutes, increasing to 55 minutes from FMUs 20-40 km away and 61 minutes in more remote FMUs. In women who gave birth within 60 minutes after transfer, adverse neonatal outcomes occurred in 1-2% of transfers. CONCLUSIONS: Transfers from home or FMU commonly take up to 60 minutes from decision to transfer, to first assessment in an OU, even for transfers for potentially urgent reasons. Most transfers are not urgent and emergencies and adverse outcomes are uncommon, but urgent transfer is more likely for nulliparous women.

Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study.

OBJECTIVE: To compare perinatal outcomes, maternal outcomes, and interventions in labour by planned place of birth at the start of care in labour for women with low risk pregnancies. DESIGN: Prospective cohort study. SETTING: England: all NHS trusts providing intrapartum care at home, all freestanding midwifery units, all alongside midwifery units (midwife led units on a hospital site with an obstetric unit), and a stratified random sample of obstetric units. PARTICIPANTS: 64,538 eligible women with a singleton, term (≥37 weeks gestation), and "booked" pregnancy who gave birth between April 2008 and April 2010. Planned caesarean sections and caesarean sections before the onset of labour and unplanned home births were excluded. MAIN OUTCOME MEASURE: A composite primary outcome of perinatal mortality and intrapartum related neonatal morbidities (stillbirth after start of care in labour, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus, or fractured clavicle) was used to compare outcomes by planned place of birth at the start of care in labour (at home, freestanding midwifery units, alongside midwifery units, and obstetric units). RESULTS: There were 250 primary outcome events and an overall weighted incidence of 4.3 per 1000 births (95% CI 3.3 to 5.5). Overall, there were no significant differences in the adjusted odds of the primary outcome for any of the non-obstetric unit settings compared with obstetric units. For nulliparous women, the odds of the primary outcome were higher for planned home births (adjusted odds ratio 1.75, 95% CI 1.07 to 2.86) but not for either midwifery unit setting. For multiparous women, there were no significant differences in the incidence of the primary outcome by planned place of birth. Interventions during labour were substantially lower in all non-obstetric unit settings. Transfers from non-obstetric unit settings were more frequent for nulliparous women (36% to 45%) than for multiparous women (9% to 13%). CONCLUSIONS: The results support a policy of offering healthy women with low risk pregnancies a choice of birth setting. Women planning birth in a midwifery unit and multiparous women planning birth at home experience fewer interventions than those planning birth in an obstetric unit with no impact on perinatal outcomes. For nulliparous women, planned home births also have fewer interventions but have poorer perinatal outcomes.

Vitamin A supplementation for reducing the risk of mother-to-child transmission of HIV infection.

BACKGROUND: Observational studies of pregnant women in sub-Saharan Africa have shown that low serum vitamin A levels are associated with an increased risk of mother-to-child transmission (MTCT) of HIV. Vitamin A is cheap and easily provided through existing health services in low-income settings. It is thus important to determine the effect of routine supplementation of HIV positive pregnant or breastfeeding women with this vitamin on the risk of MTCT of HIV, which currently results in more than 1000 new HIV infections each day world-wide. OBJECTIVES: We aimed to assess the effect of antenatal and or postpartum vitamin A supplementation on the risk of MTCT of HIV as well as infant and maternal mortality and morbidity. SEARCH STRATEGY: In June 2010 we searched the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, AIDS Education Global Information System, and WHO International Clinical Trials Registry Platform; and checked reference lists of identified articles for any studies published after the earlier version of this review was updated in 2008. SELECTION CRITERIA: We selected randomised controlled trials conducted in any setting that compared vitamin A supplementation with placebo in known HIV-infected pregnant or breastfeeding women. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed trial eligibility and quality and extracted data. We calculated relative risks (RR) or mean differences (MD), with their 95% confidence intervals (CI) for each study. We conducted meta-analysis using a fixed-effects method (when there was no significant heterogeneity between study results, i.e. P>0.1) or the random-effects method (when there was significant heterogeneity), and report the Higgins' statistic for all pooled effect measures. MAIN RESULTS: Five randomised controlled trials which enrolled 7,528 HIV-infected women (either during pregnancy or the immediate postpartum period) met our inclusion criteria. These trials were conducted in Malawi, South Africa, Tanzania, and Zimbabwe between 1995 and 2005. We combined the results of these trials and found no evidence that vitamin A supplementation has an effect on the risk of MTCT of HIV (4 trials, 6517 women: RR 1.04, 95% CI 0.87 to 1.24; I(2)=68%). However, antenatal vitamin A supplementation significantly improved birth weight (3 trials, 1809 women: MD 89.78, 95%CI 84.73 to 94.83; I(2)=33.0%), but there was no evidence of an effect on preterm births (3 trials, 2110 women: RR 0.88, 95%CI 0.65 to 1.19; I(2)=58.1%), stillbirths (4 trials, 2855 women: RR 0.99, 95%CI 0.68 to 1.43; I(2)=0%), deaths by 24 months (2 trials, 1635 women: RR 1.03, 95%CI 0.88 to 1.20; I(2)=0%), postpartum CD4 levels (1 trial, 727 women: MD -4.00, 95% CI -51.06 to 43.06), and maternal death ( 1 trial, 728 women: RR 0.49, 95%CI 0.04 to 5.37). AUTHORS' CONCLUSIONS: Current best evidence shows that antenatal or postpartum vitamin A supplementation probably has little or no effect on mother-to-child transmission of HIV. According to the GRADE classification, the quality of this evidence is moderate; implying that the true effect of vitamin A supplementation on the risk of mother-to-child transmission of HIV is likely to be close to the findings of this review, but that there is also a possibility that it is substantially different.

Donor breast milk versus infant formula for preterm infants: systematic review and meta-analysis.

OBJECTIVES: To compare the effect of donor breast milk with infant formula in preterm infants. Separate comparisons with formula were made for donor breast milk that was: (1) given as a sole diet; (2) given as a supplement to mother's own breast milk; and (3) fortified with macronutrients and micronutrients. The main outcomes were death, necrotising enterocolitis (NEC), infection, growth and development. DATA SOURCES: Electronic databases-Cochrane, CENTRAL, MEDLINE, EMBASE, CINAHL, and HMIC: DH. REVIEW METHODS: Systematic review and meta-analysis of trials and observational studies of preterm or low birthweight infants. RESULTS: Seven studies (including five randomised controlled trials), all from the 1970s and 1980s, fulfilled the inclusion criteria. All studies compared the effect of sole donor breast milk with formula (combined n = 471). One of these also compared the effect of donor breast milk with formula given as a supplement to mother's own milk (n = 343). No studies examined fortified donor breast milk. A meta-analysis based on three studies found a lower risk of NEC in infants receiving donor breast milk compared with formula (combined RR 0.21, 95% CI 0.06 to 0.76). Donor breast milk was associated with slower growth in the early postnatal period, but its long-term effect is unclear. CONCLUSION: Donor breast milk is associated with a lower risk of NEC and slower growth in the early postnatal period, but the quality of the evidence is limited. Further research is needed to confirm these findings and measure the effect of fortified or supplemented donor breast milk.

Acute obstetric emergency drill in England and Wales: a survey of practice.

Multidisciplinary training for obstetric emergencies is an issue of current interest and debate in the UK. This paper presents a survey of current practice in obstetric emergency drill training in England and Wales. A wide range of training methods and opinions about these methods are demonstrated in this survey. There is much interest in improving the management of obstetric emergencies and this is to be encouraged. However, reliable methods to assess and thereby optimise methods are urgently required in order that women and their babies can realise the maximum benefit from these complex interventions.