The acceptability of implementation of group B Streptococcus testing: Perspectives from women and health professionals in the GBS3 trial: A qualitative study.

OBJECTIVE: To determine the acceptability of different methods of routine testing for group B Streptococcus (GBS) colonisation to pregnant women and health care professionals (HCPs), and to examine barriers and facilitators to their implementation. DESIGN: Qualitative study, embedded in a cluster randomised trial SETTING: Four NHS maternity units participating in the GBS3 Trial: two conducting routine antenatal enriched culture medium (ECM) testing; and two using routine rapid intrapartum testing. Sample 39 women and 25 HCPs purposively sampled to ensure representation of women with various birthing experiences and different professions. Methods Women were interviewed approximately 12 weeks postpartum by telephone or online video call, using a semi-structured topic guide. HCPs were interviewed during the testing period of the trial. Interviews were transcribed for thematic analysis and summarised using the framework method. RESULTS: Four categories of interest emerged: (1) views of routine testing; (2) acceptability of the testing procedure; (3) preferences on the types of test; (4) improving the testing procedure. Routine GBS testing was well received by both women and HCPs. Most participants found the procedure acceptable and were willing to receive the offer of testing in the future. Preferences for different testing methods varied, with participants emphasising the importance of evidence and informed choice. CONCLUSIONS: Routine GBS testing is acceptable to most women and HCPs. Areas for consideration and the practicalities of implementing testing in maternity services are highlighted.

GBS vaccines in the UK: a round table discussion.

Background: Group B streptococcus (GBS) remains a leading cause of infant sepsis, meningitis and death despite intrapartum antibiotic prophylaxis. A vaccine is urgently required, and two candidates are in advanced clinical trials. For successful GBS vaccine implementation, especially if a vaccine is licensed based on an immunological threshold, there must be cross-sector engagement, effective advocacy, robust plans for phase IV studies and equitable access. Meeting: A round-table discussion, held at St George's University of London, reviewed the current position of GBS vaccines in the UK context, focusing on phase IV plans, convening a diverse group of stakeholders from across the UK, with a role in GBS vaccine licensure, advocacy, implementation or effectiveness evaluation.Presentations outlined the latest UK epidemiology, noting the rising infant invasive GBS (iGBS) infection rates from 1996 to 2021 for both early and late onset disease, with the highest disease rates in Black infants (1.1/1000 livebirths vs white infants (0.81/1000 livebirths). Potential coverage of the candidate vaccines was high (>95%). Regulatory input suggested that EU regulators would consider waiving the need for a pre-licensure efficacy study if a putative correlate of protection could be adequately justified. Phase IV study methodologies for a GBS vaccine were considered, largely based on previous UK maternal vaccine assessments, such as a nationwide cohort study design using a vaccine register and a maternal services dataset. Other strategies were also discussed such as a cluster or stepped-wedge randomised trial to evaluate implementation outcomes. Opportunities for advocacy, education and engagement with additional key partners were discussed and identified. Conclusions: With an approved GBS vaccine a near possibility, planning of phase IV studies and identification of critical barriers to implementation are urgently needed. Cross-sector engagement is essential and will facilitate a successful pathway.

Severe perineal lacerations in induction of labor versus expectant management: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: This study aimed to evaluate if induction of labor (IOL) is associated with an increased risk of severe perineal laceration. DATA SOURCES: A systematic search was conducted in MEDLINE, Ovid, Scopus, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, and CINHAL using a combination of keywords and text words related to "induction of labor," "severe perineal laceration," "third-degree laceration," "fourth-degree laceration," and "OASIS" from inception of each database until January 2023. STUDY ELIGIBILITY CRITERIA: We included all randomized controlled trials (RCTs) comparing IOL to expectant management of a singleton, cephalic pregnancy at term gestation that reported rates of severe perineal laceration. STUDY APPRAISAL AND SYNTHESIS AND METHODS: The primary outcome of interest was severe perineal laceration, defined as 3rd- or 4th-degree perineal lacerations. We conducted meta-analyses using the random effects model of DerSimonian and Laird to determine the relative risks (RR) or mean differences with 95% confidence intervals (CIs). Bias was assessed using guidelines established by Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: A total of 11,187 unique records were screened and ultimately eight RCTs were included, involving 13,297 patients. There was no statistically significant difference in the incidence of severe perineal lacerations between the IOL and expectant management groups (209/6655 [3.1%] vs 202/6641 [3.0%]; RR 1.03, 95% CI 0.85, 1.26). There was a statistically significant decrease in the rate of cesarean birth (1090/6655 [16.4%] vs 1230/6641 [18.5%], RR 0.89, 95% CI 0.82, 0.95) and fetal macrosomia (734/2696 [27.2%] vs 964/2703 [35.7%]; RR 0.67: 95% CI 0.50, 0.90) in the IOL group. CONCLUSION: There is no significant difference in the risk of severe perineal lacerations between IOL and expectant management in this meta-analysis of RCTs. Furthermore, there is a lower rate of cesarean births in the IOL group, indicating more successful vaginal deliveries with similar rates of severe perineal lacerations. Patients should be counseled that in addition to the known benefits of induction, there is no increased risk of severe perineal lacerations.

The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study.

BACKGROUND: Group B streptococcus (GBS) is a bacterium carried by 20-25 % of pregnant women in the UK, which can be transmitted from pregnant women to their babies at the time of birth. Women can be tested for GBS in pregnancy using a vaginal-rectal swab, however, this testing is currently not routinely offered in the UK. A large clinical trial is underway to determine the clinical and cost-effectiveness of routine testing (ISRCTN reference number ISRCTN49639731). A crucial part of understanding whether this type of test should be implemented is women's views on the acceptability of being offered GBS tests, their preferences towards testing procedures and their willingness to receive these tests. AIM: To explore women's views on the acceptability of different methods of Group B streptococcal bacteria (GBS) testing in pregnancy, including self-swabbing procedures. METHODS: A convenience sample of 19 women (5 pregnant and 14 postpartum) were interviewed using a semi-structured interview guide. Interviews were transcribed and analysed using systematic thematic analysis. RESULTS: Findings show that many of the women interviewed were not concerned about being offered a GBS test, were willing to provide a sample and felt positive towards samples being taken to detect GBS. Women varied in their preferences on the best time for sampling. Some thought being approached during pregnancy gave them time to understand the purpose of testing, prepare for what may happen next and ask questions about potential treatment if needed. Others thought labour was a good time to provide accurate results on GBS carriage at birth and reduce unnecessary worry during pregnancy. However, women were concerned that they may be unable to make an informed decision in labour due to time, pain and the prospect of birthing quickly. Women perceived clinician swabbing as more accurate than self-sampling; however, many thought clinician swabbing might be embarrassing so self-swabs should be available to increase uptake for some women. CONCLUSIONS: Overall, women thought both pregnancy and labour were acceptable times to test for GBS. The majority found both clinician and self-swabbing procedures acceptable; however, many had a preferred swabbing option and thought women should be given the choice of the swabbing procedure most acceptable to them. It is important that women are given information about GBS testing and its procedures in pregnancy regardless of when the GBS swabbing is performed.

Management of Impacted Fetal Head at Caesarean Birth: Scientific Impact Paper No. 73.

Over one-quarter of women in the UK have a caesarean birth (CB). More than one in 20 of these births occurs near the end of labour, when the cervix is fully dilated (second stage). In these circumstances, and when labour has been prolonged, the baby's head can become lodged deep in the maternal pelvis making it challenging to deliver the baby. During the caesarean birth, difficulty in delivery of the baby's head may result - this emergency is known as impacted fetal head (IFH). These are technically challenging births that pose significant risks to both the woman and baby. Complications for the woman include tears in the womb, serious bleeding and longer hospital stay. Babies are at increased risk of injury including damage to the head and face, lack of oxygen to the brain, nerve damage, and in rare cases, the baby may die from these complications. Maternity staff are increasingly encountering IFH at CB, and reports of associated injuries have risen dramatically in recent years. The latest UK studies suggest that IFH may complicate as many as one in 10 unplanned CBs (1.5% of all births) and that two in 100 babies affected by IFH die or are seriously injured. Moreover, there has been a sharp increase in reports of babies having brain injuries when their birth was complicated by IFH. When an IFH occurs, the maternity team can use different approaches to help deliver the baby's head at CB. These include: an assistant (another obstetrician or midwife) pushing the head up from the vagina; delivering the baby feet first; using a specially designed inflatable balloon device to elevate the baby's head and/or giving the mother a medicine to relax the womb. However, there is currently no consensus for how best to manage these births. This has resulted in a lack of confidence among maternity staff, variable practice and potentially avoidable harm in some circumstances. This paper reviews the current evidence regarding the prediction, prevention and management of IFH at CB, integrating findings from a systematic review commissioned from the National Guideline Alliance.

Self-collected versus health-care professional taken swab for identification of vaginal-rectal colonisation with group B streptococcus in late pregnancy: a systematic review.

BACKGROUND: Testing for group B streptococcus (GBS) requires a vaginal-rectal swab in late pregnancy. OBJECTIVE: A systematic review of the test accuracy of a self-collected swab compared with a health-care professional collected swab in the diagnosis of GBS colonisation. SEARCH STRATEGY: The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects [DARE] and the Cochrane Central Register of Controlled Trials [CENTRAL]), EMBASE, MEDLINE and Trip were searched in May 2022. SELECTION CRITERIA: Randomised trials, test accuracy studies or diagnostic yield studies that compared the accuracy of a self-collected vaginal-rectal swab, compared to that taken by a health-care professional, for the detection of GBS colonisation in the third trimester. DATA COLLECTION AND ANALYSIS: Two researchers independently screened, selected studies, extracted data and assessed study quality. MAIN RESULTS: 10 studies, with 2578 women were included. Pooled sensitivity of self-collected swabs was 0.90 (95% confidence interval [CI] 0.81 to 0.95) and pooled specificity was 0.98 (95% CI 0.96 to 0.99). CONCLUSION: This study provides reassuring evidence that self-collected swabs for maternal GBS colonisation are highly accurate relative to swabs collected by health-care professionals. Women requiring a swab for GBS colonisation can self-swab with appropriate instructions if they choose. FUNDING: Personal fellowship from the University of Nottingham for KFW.

Women's knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study.

BACKGROUND: 20-25% pregnant women in the UK carry group B streptococcus (GBS) which, if left undetected, is transmitted from pregnant mothers to their babies during birth in 36% of cases. This transmission leads to early onset GBS infection (EOGBS) in 1% of babies which is a significant cause of mortality and morbidity in newborns. The literature available suggests women's knowledge of GBS is low, with many women unaware of the GBS bacterium. In addition, attitudes towards GBS testing have not been widely examined, with research mostly focusing on attitudes towards potential GBS vaccination. AIM: To examine women's knowledge of GBS in pregnancy and their attitudes towards GBS testing. METHODS: Semi-structured interviews with 19 women (5 pregnant and 14 postpartum). Interviews were transcribed and analysed using systematic thematic analysis. RESULTS: Four main theme categories were identified. Participants had varying levels of awareness of GBS, with the information provided by health professionals not being clearly explained or the importance of GBS being downplayed. Participants wanted more information and to feel informed. Overall, the majority had positive attitudes towards being offered and taking up GBS testing, and this study identified some of the key factors influencing their decision. These included: seeing GBS testing as just another routine procedure during pregnancy; that it would lower the risk of their baby becoming unwell; provide reassurance; and allow them to prepare; and provide informed choices. Participants also expressed a few common concerns about GBS testing: questioning the invasiveness of the procedure; risks to themselves and the baby; and the risk of receiving antibiotics. CONCLUSIONS: Women need clear, detailed information about GBS and GBS testing, and women's concerns are important to address if routine GBS testing is implemented. The efficacy of implementing routine universal testing in the UK is currently being investigated in a large multi-centre clinical trial; the GBS3trial, further qualitative research is needed to look at the acceptability of different methods of GBS testing, as well as the acceptability of GBS testing to women in specific groups, such as those planning a home birth or those from different ethnic backgrounds.

Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study.

Background: Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance. Objective: To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean. Design: A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial. Setting: Secondary care. Participants: Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents. Results: Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable. Limitations: Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial. Conclusions: We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK. Future work: We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies. Study registration: This study is registered as Research Registry 4942. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.

Text: One-quarter of UK pregnant women have a caesarean section. Most of these procedures are straightforward, but in a small number of cases unexpected complications can make the birth difficult. One complication, an impacted fetal head, may happen when caesarean sections are done in the second 'pushing' stage of labour. If the baby's head is low and wedged in the woman's pelvis, lifting it can be difficult, which can result in damage to the mother's womb and vagina, and to her baby. Occasionally, babies die. There are different techniques doctors and midwives can use to make these births easier, but there is uncertainty around which is best. To plan a trial to test these techniques, we needed to know how often impacted head happens, what techniques are used to manage it and whether or not research is acceptable to parents and health-care professionals. We surveyed doctors and midwives to find out which techniques they use and what training they need. We surveyed parents and pregnant women and interviewed women who had experienced a second-stage caesarean. We collected information from UK hospitals to find out how common this is and the impact on women and babies. We found out the following. List: • Around 7% of caesareans take place in second stage, and impacted fetal head occurs in 16% of these births. List: • One-third of women would consent to take part in a trial, if the complication happened to them. List: • Nearly all midwives and doctors thought that this research was important and would be willing to take part. Text: Using all of the information we collected, we designed a clinical trial. We wanted to compare two techniques for managing an impacted fetal head. The first is the vaginal push technique, where the doctor or midwife puts their hand into the mother's vagina to push her baby's head up, and the second is the fetal pillow, a device inserted into the mother's vagina before the operation starts to dislodge the baby's head upwards.

The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study.

BACKGROUND: Caesarean sections (CS) account for 26% of all births in the UK, of which at least 5% are done at full dilatation, in the second stage of labour. Second stage CS may be complicated by the fetal head being deeply impacted in the maternal pelvis, requiring specialist skills to achieve a safe birth. Numerous techniques are used to manage impacted fetal head, however, there are no national clinical guidelines in the UK. AIM: To explore health professionals' and women's views on the acceptability and feasibility of a randomised controlled trial (RCT) designed to explore approaches to managing an impacted fetal head during emergency CS. METHODS: Semi-structured interviews with 10 obstetricians and 16 women (6 pregnant and 10 who experienced an emergency second stage CS). Interviews were transcribed and analysed using systematic thematic analysis. RESULTS: The findings considered the time at which you obtain consent, how and when information about the RCT is presented, and barriers and facilitators to recruiting health professionals and women into the RCT. Obstetricians emphasised the importance of training in the techniques, as well as the potential conflict between the RCT protocol and current site or individual practices. Women said they would trust health professionals' to use the most appropriate technique and abandon the RCT protocol if necessary. Similarly, obstetricians raised the tension between the RCT protocol versus safety in reverting to what they knew under emergency situations. Both groups reflected on how this might affect the authenticity of the results. A range of important maternal, infant and clinical outcomes were raised by women and obstetricians. However, there were varying views on which of the two RCT designs presented to participants would be preferred. Most participants thought the RCT would be feasible and acceptable. CONCLUSIONS: This study suggests an RCT designed to evaluate different techniques for managing an impacted fetal head would be feasible and acceptable. However, it also identified a number of challenges that need to be considered when designing such an RCT. Results can be used to inform the design of RCTs in this area.

Techniques for managing an impacted fetal head at caesarean section: A systematic review.

A complication arising at caesarean birth when the baby's head is deeply engaged in the pelvis and may be difficult to deliver, is known as an 'impacted fetal head'. This obstetric emergency occurs in 16% of second stage caesarean sections. Multiple techniques are described in the literature to manage the complication but there is no consensus regarding which technique results in the best maternal and neonatal outcomes. The objective of this review is to determine which technique for managing impacted fetal head at caesarean section has the best maternal and neonatal outcomes. A literature search of three electronic databases was conducted in November 2021. Studies directly comparing two methods for the management of impacted fetal head at caesarean section in the second stage were included. Systematic reviews, meta-analyses, case-control studies, and studies not fitting the search criteria were excluded. Data was extracted in Covidence and meta-analysis of the six most commonly reported outcomes was conducted using RevMan 5.4. In total, 16 studies (3344women) were included. 13 studies (2506women) compared the push method with reverse breech extraction. meta-analysis showed that risk of extension of the uterine incision, blood transfusion, bladder injury, postpartum haemorrhage, NICU admission and Apgar score <7 at 5 min were significantly higher with the push method compared with reverse breech extraction. Three studies (838women) compared the push method with Patwardhan's technique. meta-analysis of studies comparing the push method with Patwardhan's technique found no significant differences between the two groups in any of the six maternal or neonatal outcomes. Evidence derived from small, inadequately powered studies suggests reverse breech extraction is associated with better outcomes than the push method. The method which produces the best outcomes is still unknown as not all methods have been tested. Further high quality, adequately powered RCTs are warranted for definitive conclusions to be drawn and to ameliorate the paucity of evidence on how best to manage this complication.

Synthetic osmotic dilators (Dilapan-S) or dinoprostone vaginal inserts (Propess) for inpatient induction of labour: A UK cost-consequence model.

OBJECTIVE: To estimate the costs of synthetic osmotic dilators (Dilapan-S) compared to dinoprostone vaginal inserts (Propess) for inpatient induction of labour (IOL). STUDY DESIGN: A population-level, Markov model-based cost-consequence analysis was developed to compare the impact of using Dilapan-S versus Propess. The time horizon was modelled from admission to birth. The target population was women requiring inpatient IOL from 37 weeks with an unfavourable cervix in the UK. Mean population characteristics reflected those of the SOLVE (NCT03001661) trial. No patient data were included in this analysis. The care pathways and staff workload were modelled using data from the SOLVE trial and clinical experience. Cost and clinical inputs were sourced from the SOLVE trial and peer-reviewed literature. Costs were inflated to 2020 British pounds (GBP, £). Outcomes were reported as an average per woman for total costs and required staff time (minutes) from admission for IOL until birth. The model robustness was assessed using a probabilistic, multivariate sensitivity analysis of 2,000 simulations with results presented as the median (interquartile range, IQR). RESULTS: Dilapan-S was cost neutral compared to Propess. Midwife and obstetrician times were decreased by 146 min (-11%) and 11 min (-54%), respectively. Sensitivity analysis showed that in 78% of simulations, use of Dilapan-S reduced midwife time with a median of -160 min (IQR -277 to -24 min). Costs were reduced in 54% of simulations (median -£33, IQR -£319 to £282). CONCLUSIONS: The model indicates that adoption of Dilapan-S is likely to be cost-neutral and reduce staff workload in comparison to Propess. Results require support from real-world data and further exploration of Dilapan-S is to be encouraged.

Recruitment of pregnant women to randomised trials of COVID 19 treatments, and pharmaceutical treatments received outside such trials: A research article.

OBJECTIVES: To document how many pregnant women with COVID-19 reported in the literature had participated in randomised trials, what treatments they received outside such trials and compare the latter with evidence-based treatment recommendations. STUDY DESIGN: A systematic review of observational studies. METHODS: Two clinical trial registries were searched to identify COVID-19 trials open to pregnant women. Studies were then extracted from a regularly updated list of scientific case reports and case series of confirmed or suspected maternal COVID-19 in pregnancy to identify the number of women enrolled into a trial and the pharmaceutical treatments they received outside such trials. RESULTS: 156 studies (case reports, case series and registries) reporting 43,185 pregnant women with COVID-19, after de-duplication. Of these 2,671 (6.2%) were potentially eligible for a randomised trial but only seven women (0.26%) were reported to have enrolled. For 2,839 women the papers included information on treatment received, 1515/2829 (54%) women had received ≥ 1 treatment and in total a COVID-19 pharmaceutical treatment was administered 1,296 times outside of a trial. In 566 (44%) cases the treatments administered to the pregnant women were not recommended by the National Institutes of Health (NIH) at the time of administration. Of 179 case reports of women with COVID 19 in pregnancy, 109/179 women received ≥ 1 COVID-19 pharmaceutical treatment and in total COVID-19 experimental pharmaceutical treatments were administered 274 times. CONCLUSION: During the early phase of the COVID-19 pandemic, pregnant women excluded from randomised trials did not avoid unproven or ineffective treatments.

Impacted fetal head during second stage Caesarean birth: A prospective observational study.

OBJECTIVE: To determine the incidence of, and complication rates from, impacted fetal head at full dilatation Caesarean birth in the UK, and record what techniques were used. DESIGN: Prospective observational study using the UK Obstetric Surveillance System (UKOSS). SETTING: 159 (82%) of the 194 UK hospitals with obstetric units. POPULATION: All women who underwent second stage Caesarean birth in the UK between 1st March and 31st August 2019. Further information was collected on cases where a dis-impaction technique was used, or the operating surgeon experienced 'difficulty' in delivering the head. METHODS: Prospective observational study. MAIN OUTCOME MEASURES: Technique(s) used, maternal and neonatal outcomes. RESULTS: 3,518 s stage Caesarean births reported. The surgeon used a dis-impaction technique or reported 'difficulty' in 564 (16%) of these. The most common dis-impaction techniques used were manual elevation of the head by an assistant through the vagina (n = 235) and a fetal "pillow" (n = 176). Thirteen babies (2%) died or sustained severe injury. Four babies died (two directly attributable to the impacted fetal head). CONCLUSIONS: Difficulty with delivery of the fetal head and the use of dis-impaction techniques during second stage Caesarean sections are common but there is no consensus as to the best method to achieve delivery and in what order.

Managing an impacted fetal head at caesarean section: a UK survey of healthcare professionals and parents.

OBJECTIVE(S): To understand current practice, expertise and training requirements for management of an impacted fetal head (IFH) at caesarean section (CS) in the UK, and whether a clinical trial of techniques to manage an IFH is acceptable. STUDY DESIGN: Five hundred and thirty-eight online surveys were completed by obstetricians (n = 206), obstetric anaesthetists (n = 38), midwives (n = 35) and parents (n = 259). Data was collected on incidences of CS and IFH, current use of techniques, and acceptability of a clinical trial to manage an IFH from health care professionals. Information on incidences of CS and recollection of an IFH, acceptability of techniques, and likelihood of taking part in a clinical trial were sought from parents. RESULTS: The most common technique used by obstetricians (84%) and midwives (69%) was the 'push technique'. Eighty-seven percent of health care professionals would be willing to participate in a clinical trial, with 89% confirming that results would guide their clinical practice. Most parents expressed reluctance regarding participation in a clinical trial during labour (62%), due to preferring a doctor to adopt the technique they felt most comfortable with (63%). CONCLUSION(S): Given the lack of national guidance on appropriate techniques, no formal training, and no consensus on best practice for the management of an IFH during emergency CS, it is perhaps not surprising that the majority of heath care professionals would be willing to participate in a clinical trial, where results will guide their clinical practice. The future development of clinical trials, involving relevant stakeholders in the design of such trials, is crucial to improve upon the guidance and training provided to staff who may encounter an IFH.

The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30-33 weeks gestational age).

BACKGROUND: In the UK, approximately 8% of live births are preterm (before 37 weeks gestation), more than 90% of whom are born between 30 and 36 weeks, forming the largest proportion of a neonatal units' workload. Neonatologists are cautious in initiating full milk feeds for preterm infants due to fears of necrotising enterocolitis (NEC). There is now evidence to dispute this fear. Small studies have shown that feeding preterm infants full milk feeds enterally from birth could result in a shorter length of hospital stay, which is important to parents, clinicians and NHS services without increasing the risk of NEC. This trial aims to investigate whether full milk feeds initiated in the first 24 h after birth reduces the length of hospital stay in comparison to introduction of gradual milk feeding with IV fluids or parenteral nutrition. METHODS: FEED1 is a multi-centre, open, parallel group, randomised, controlled superiority trial of full milk feeds initiated on the day of birth versus gradual milk feeds for infants born at 30+0 to 32+6 (inclusive) weeks gestation. Recruitment will take place in around 40 UK neonatal units. Mothers will be randomised 1:1 to full milk feeds, starting at 60 ml/kg day, or gradual feeds, as per usual local practice. Mother's expressed breast milk will always be the first choice of milk, though will likely be supplemented with formula or donor breast milk in the first few days. Feeding data will be collected until full milk feeds are achieved (≥ 140 ml/kg/day for 3 consecutive days). The primary outcome is length of infant hospital stay. Additional data will be collected 6 weeks post-discharge. Follow-up at 2 years (corrected gestational age) is planned. The sample size is 2088 infants to detect a between group difference in length of stay of 2 days. Accounting for multiple births, this requires 1700 women to be recruited. Primary analysis will compare the length of hospital stay between groups, adjusting for minimisation variables and accounting for multiple births. DISCUSSION: This trial will provide high-quality evidence on feeding practices for preterm infants. Full milk feeds from day of birth could result in infants being discharged sooner. TRIAL REGISTRATION: ISRCTN ISRCTN89654042 . Prospectively registered on 23 September 2019: ISRCTN is a primary registry of the WHO ICTRP network, and all items from the WHO Trial Registration dataset are included.

COVID-19 and pregnancy: A comparison of case reports, case series and registry studies.

BACKGROUND: Selection, outcome and publication biases are well described in case reports and case series but may be less of a problem early in the appearance of a new disease when all cases might appear to be worth publishing. OBJECTIVE: To use a prospectively collected database of primary sources to compare the reporting of COVID-19 in pregnancy in case reports, case series and in registries over the first 8 months of the pandemic. STUDY DESIGN: MEDLINE, Embase and Maternity and Infant Care databases were searched from 22 March to 5 November 2020, to create a curated list of primary sources. Duplicate reports were excluded. Case reports, case series and registry studies of pregnant women with confirmed COVID-19, where neonatal outcomes were reported, were selected and data extracted on neonatal infection status, neonatal death, neonatal intensive care unit admission, preterm birth, stillbirth, maternal critical care unit admission and maternal death. RESULTS: 149 studies comprising 41,658 mothers and 8,854 neonates were included. All complications were more common in case reports, and in retrospective series compared with presumably prospective registry studies. Extensive overlap is likely in registry studies, with cases from seven countries reported by multiple registries. The UK Obstetric Surveillance System was the only registry to explicitly report identification and removal of duplicate cases, although five other registries reported collection of patient identifiable data which would facilitate identification of duplicates. CONCLUSIONS: Since it is likely that registries provide the least biased estimates, the higher rates seen in the other two study designs are probably due to selection or publication bias. However even some registry studies include self- or doctor-reported cases, so might be biased, and we could not completely exclude overlap of cases in some registries.

Evidence around early induction of labor in women of advanced maternal age and those using assisted reproductive technology.

Worldwide, there has been a trend toward later motherhood. Concurrently, the incidence of subfertility has been on the rise, necessitating conception using assisted reproductive technologies (ARTs). These pregnancies are considered high risk due to fetal complications such as antepartum stillbirth and growth restriction and maternal complications such as increase in maternal morbidity and mortality. Early induction of labor can help to mitigate these risks. However, this has to be balanced against the iatrogenic harms of earlier delivery to both the baby, including respiratory distress and NICU stay, and the mother who might experience longer labor and other complications such as uterine hyperstimulation. Induction of labor at 39 weeks is the optimal timing for preventing antepartum stillbirth and avoiding iatrogenic harm. Delivery by elective cesarean section is not advocated as its benefits in these patients are unclear compared with the short- and long-term complications of a major abdominal surgery.

Timing of umbilical cord clamping for preterm infants in low-and-middle-income countries: A survey of current practice.

INTRODUCTION: The optimal timing of umbilical cord clamping in preterm infants has been contested for years. Previously, it was common practice to clamp the cord immediately after birth. There is now high-quality evidence that delayed cord clamping (DCC) (>60 seconds) reduces mortality in preterm infants by allowing placental transfusion. However, it is unclear how well DCC has been implemented into practice. This study aims to assess current practice of timing of cord clamping for both stable and unstable preterm infants in LMICs, where rates of preterm birth and neonatal mortality are high and where there is the potential to see the greatest benefit from implementation of DCC. METHODS: An online survey was created and, following user-testing, circulated to maternity workers in LMICs via The International Federation of Gynaecology and Obstetrics (FIGO), social media and other existing collaborators. Analyses were conducted using SPSS. RESULTS: 70 responses were received across 10 LMICs. 42/70 (60%) participants reported practising DCC for stable preterm infants, compared to only 4/70 (6%) for unstable infants. For stable infants, 22/42 (52%) of those who practised DCC gave their main reason as being "recommended by guidelines". 13/70 (19%) participants said they didn't follow any guidelines for the timing of cord clamping. Only 25/70 (36%) were aware of guidelines for cord clamping in their hospitals, and 9/70 (13%) were aware of related quality improvement projects (QIPs). DISCUSSION: Despite evidence to support the use of DCC, timing of cord clamping in LMICs is variable. Unstable infants requiring stabilisation could benefit most from placental transfusion, yet few respondents practised DCC and few hospitals had QIPs in place. Higher-quality guidelines and training could increase implementation of DCC, and development of affordable equipment to allow bedside resuscitation with the cord intact could aid in reducing neonatal mortality.

Episiotomy and Initiation of Human Milk Feeds: A Retrospective Observational Study.

Objective: To investigate the association, in the United Kingdom, between having an episiotomy during childbirth and giving human milk by any modality as an infant's first feed. We also identified maternal demographic factors and perinatal experiences associated with increased chance of the infant's first feed being human milk. Study Design: Retrospective observational cohort study at two large maternity units within district general hospitals in the United Kingdom. Population: Mothers giving birth vaginally to singleton babies at ≥34 weeks and ≥1,800 g. Methods and Main Outcome Measures: Deidentified data from hospital records were analyzed. The odds ratio (OR) of a mother giving human milk for an infant's first feed after episiotomy versus no episiotomy was calculated using a chi-squared test. Logistic regression was used to investigate and then control for confounders known to affect breastfeeding. Results: A total of 13,906 women met the inclusion criteria (2,113 had had an episiotomy and 11,793 had not). Human milk was given as a first feed to 70% of infants in the study population. Women whose infants received their first feed as human milk were on average older, had lower body mass index, lived in an area of less socioeconomic deprivation, and had fewer previous births than those women who gave formula milk as the first feed to their infant. The occurrence of an episiotomy during delivery was not associated with a change in the odds of the infant receiving human milk for the first feed (OR: 1.12 [confidence interval, CI: 0.96-1.38]). Where a woman had skin-to-skin care with her infant straight after birth, the infant was more likely to receive human milk as a first feed (OR: 4.23 [CI: 3.59-4.98]). Conclusion: There is no link between episiotomy during delivery and the odds of a woman giving human milk as the first feed to her infant.