Nicola Vousden

Assessment of a Full Dilatation Cesarean Delivery Simulator

OBJECTIVE: To assess a full dilatation cesarean delivery simulator and to establish expert consensus on the most effective techniques for safe delivery. METHODS: Three delivery scenarios with increasing degrees of difficulty were tested. Face and content validity were assessed using visual analog scale (VAS) scores on how realistic the simulator was and how useful it would be for training, respectively. Construct validity was assessed by comparing success at delivery and time taken between senior doctors and junior doctors. Expert opinion was sought through a questionnaire. RESULTS: The training scenarios were undertaken by 30 doctors working in the specialty of obstetrics and gynecology. The number of participants able to deliver and the perceived difficulty they experienced correlated with the difficulty level of the three scenarios (success: scenario 1, 100% [n=30]; scenario 2, 90% [n=27]; and scenario 3, 62% [n=16] P<.05; mean VAS: scenario 1, 29/100; scenario 2, 42/100; and scenario 3, 88/100; P<.001). Average time to delivery for each scenario was 45 seconds, 43 seconds, and 109 seconds, respectively (P<.001). Overall, 87% found the simulator to be realistic (median VAS 58/100, interquartile range 40–74) and 93% thought it would be useful as a training device (median VAS 80/100, interquartile range 55–97). Questionnaires were received from 47 consultants with an average of 18 years of experience. High uterine incision and assistance to push the fetal head up transvaginally were the only two techniques reported by more than half of the respondents. CONCLUSION: This full dilatation cesarean delivery simulator has been validated as a training device; we believe it should be used to develop a consensus for accepted techniques. LEVEL OF EVIDENCE: III

Caesarean section at full dilatation: incidence, impact and current management

The incidence of caesarean sections performed at full dilatation is increasing, and may now represent around 8000 deliveries in the UK each year. Delivery can be technically challenging due to fetal impaction into the pelvis, and may be associated with greater maternal and fetal morbidity even without failed attempt at vaginal delivery. Guidelines are needed to define optimal management, including the use of new devices to teach or assist safe delivery. Best practice should be incorporated into structured training programmes such as Managing Obstetric Emergencies and Trauma (MOET).

What is the impact of preconception abdominal cerclage on fertility: evidence from a randomized controlled trial

There is documented concern that cerclage may cause cervical stenosis or changes to the cervical mucus, which may reduce fertility. The aim of this study is to determine whether placement of a preconception abdominal cerclage affects fertility.

Assessment of a vaginal device for delivery of the impacted foetal head at caesarean section.

Abstract The aim of this study was to assess a new device (Tydeman Tube) designed to facilitate delivery of the impacted foetal head at caesarean section. Standard digital vaginal technique and the Tydeman Tube were each used to elevate the foetal head on a validated full dilatation caesarean simulator. Greater elevation of the foetal head was achieved with the Tydeman Tube than digital technique (mean difference +9.1 mm, p < 0.001). Although greater force was applied to achieve this elevation (mean difference +0.42 Kgf, p < 0.001), the force was spread over a greater area (6.97 cm2 versus 2.0 cm2). Therefore, mean pressures applied to the foetal head were lower (mean difference −2.3 Kg cm2, p < 0.001). The first uses of the Tydeman Tube in clinical practice were described. Clinicians found it easy to use and effective (mean score 7.7/10). The Tydeman Tube is an effective tool for delivering the impacted foetal head on a simulator and its initial use in clinical practise has proved positive.

PM.61 The Use of Quantitative Fetal Fibronectin to Predict Obstetric Outcome: A Comparison of a New and Established Quantitative Bedside Analyser in Asymptomatic High-Risk Women

Background Preterm birth (PTB) remains a significant cause of neonatal morbidity and mortality. The most accurate predictors of PTB are ultrasound determined cervical length (CL) and fetal fibronectin (fFN)1. Quantitative fFN can be used to further outline risk in symptomatic women2. New devices are appearing on the market. Objectives To compare the capacity of two different quantitative fetal fibronectin (fFN) systems to predict cervical shortening in asymptomatic women at high-risk of PTB. Methods Women underwent CL measurement and fFN testing between 20+0 and 24+6 week of gestation in the Preterm Surveillance Clinic at St. Thomas’ Hospital (August to November 2012). Fetal fibronectin samples were run using a bedside immunoassay system (10Q system, Hologic, Marlborough) and bedside chemiluminescence system (DryLab, Audit Diagnostics, Ireland). Results 130 fFN tests were taken from 89 women. Comparison of all test results showed considerable difference between methods (R2 0.22). A short cervix (<25 mm) was found in 14 women. The 10Q system was able to significantly detect cervical shortening (Area under the curve 0.69, 95% CI 0.57–0.82, p = 0.002), however DryLab system could not (AUC 0.52, 95% CI 0.35–0.71, p = 0.12). Hologic 10Q had a better positive predictive value than DryLab (29% vs. 22% respectively), but similar negative predictive values (88% vs 87% respectively). Secondary outcomes such as gestational age at delivery will be presented. Conclusion Quantitative fFN is associated with cervical shortening and therefore risk of imminent preterm birth in asymptomatic women. Not all commercial devices are accurate. References Bolt LA, Chandiramani M, De Greef A, Seed PT, Kurtzman J & Shennan AH. The Value of combined cervical length measurement and fetal fibronectin testing to predict spontaneous preterm birth in asymptomatic high-risk women. J Matern Fetal Neonatal Med 2011;24(7):928–932. Abbott DS, Radford SK, Seed OT, et al. Evaluation of quantitative fetal fibronectin test for spontaneous preterm birth in symptomatic women. AJOG 2012.

PM.24 Quantitative Fetal Fibronectin as a Predictor of Preterm Birth in Asymptomatic Women with Trans-Abdominal Cerclage

Background Preterm birth (PTB) remains a significant cause of neonatal morbidity and mortality. The most accurate predictors of PTB are ultrasound determined cervical length (CL) and fetal fibronectin (fFN). Cervical cerclage in situ gives more false positive fFN results1 but its value in abdominal cerclage is unknown. The aim of this study is to assess the accuracy of quantitative fFN for prediction of PTB (<34 weeks’) in asymptomatic high-risk women with abdominal cerclage. Method Secondary analysis of quantitative fFN results from EQUIPP study, taken between 20+0 and 24+6 week’ in asymptomatic women referred to specialist antenatal clinics (2010–2012), with a trans-abdominal, elective or ultrasound-indicated (emergency) cervical cerclage. Results Quantitative fFN may be most accurate for predicting PTB at <34 weeks’ in women with abdominal cerclage (AUC 1.0 (95% CI 0.0–1.0), 0.82 (95% CI 0.70 – 0.94) and 0.60 (95% CI 0.45–0.75) respectively). For delivery at <34 weeks’ the sensitivity and specificity of fFN testing was lower in women with elective and emergency cervical cerclage compared to women with abdominal cerclage (Table 1). The positive predictive value of the test is similar between groups. Abstract PM.24 Table 1 Type of Cerclage Sensitivity Specificity NPV PPV Abdominal (n = 20) 100% 95% 100% 50% Elective Cervical (n = 67) 69% 81% 92% 47% Emergency Cervical (n = 55) 74% 44% 70% 49% Conclusion Asymptomatic high-risk women with cervical cerclage in situ may have more false positive fFN test than women with an abdominal cerclage. Quantitative fFN is an accurate predictor of PTB in women with abdominal cerclage. Reference Duhig K, Chandiramani M, Seed PT, Briley AT, Kenyon AP & Shennan AH. Fetal fibronectin as a predictor of spontaneous preterm labour in asymptomatic women with cervical cerclage. BJOG 2009.116: 799–803

1 day of nitrofurantoin was not as effective as 7 days for asymptomatic bacteriuria in pregnancy

### Design: randomised controlled trial. ### Allocation: concealed.* ### Blinding: blinded (patients, healthcare providers, data collectors, and outcome assessors).* ### Setting: antenatal clinics in 7 hospitals in Thailand, the Philippines, Vietnam, and Argentina. ### Patients: 778 pregnant women (mean age 27 y) at 12–32 weeks of gestation who were diagnosed (by a 2-step screening process) as having asymptomatic bacteriuria caused by a micro-organism sensitive to nitrofurantoin. Women with symptoms of urinary tract infection (UTI), treatment of UTI in the current pregnancy, a condition requiring continuous steroid or antibiotic therapy, antibiotic hypersensitivity, or haematological disease (including glucose-6-phosphate dehydrogenase deficiency) were excluded. ### Intervention: nitrofurantoin, 100 mg orally twice daily, for 1 day (n = 386) or 7 days (n = 392). The 1-day group received placebo tablets after day 1 to …

Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial)

BackgroundObstetric haemorrhage, sepsis and pregnancy hypertension account for more than 50% of maternal deaths worldwide. Early detection and effective management of these conditions relies on vital signs. The Microlife® CRADLE Vital Sign Alert (VSA) is an easy-to-use, accurate device that measures blood pressure and pulse. It incorporates a traffic-light early warning system that alerts all levels of healthcare provider to the need for escalation of care in women with obstetric haemorrhage, sepsis or pregnancy hypertension, thereby aiding early recognition of haemodynamic instability and preventing maternal mortality and morbidity. The aim of the trial was to determine whether implementation of the CRADLE intervention (the Microlife® CRADLE VSA device and CRADLE training package) into routine maternity care in place of existing equipment will reduce a composite outcome of maternal mortality and morbidity in low- and middle-income country populations.MethodsThe CRADLE-3 trial was a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care. Each cluster crossed from routine maternity care to the intervention at 2-monthly intervals over the course of 20 months (April 2016 to November 2017). All women identified as pregnant or within 6 weeks postpartum, presenting for maternity care in cluster catchment areas were eligible to participate. Primary outcome data (composite of maternal death, eclampsia and emergency hysterectomy per 10,000 deliveries) were collected at 10 clusters (Gokak, Belgaum, India; Harare, Zimbabwe; Ndola, Zambia; Lusaka, Zambia; Free Town, Sierra Leone; Mbale, Uganda; Kampala, Uganda; Cap Haitien, Haiti; South West, Malawi; Addis Ababa, Ethiopia). This trial was informed by the Medical Research Council guidance for complex interventions. A process evaluation was undertaken to evaluate implementation in each site and a cost-effectiveness evaluation will be undertaken.DiscussionAll aspects of this protocol have been evaluated in a feasibility study, with subsequent optimisation of the intervention. This trial will demonstrate the potential impact of the CRADLE intervention on reducing maternal mortality and morbidity in low-resource settings. It is anticipated that the relatively low cost of the intervention and ease of integration into existing health systems will be of significant interest to local, national and international health policy-makers.Trial registrationISCRTN41244132. Registered on 2 February 2016.Prospective protocol modifications have been recorded and were communicated to the Ethics Committees and Trials Committees. The adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist and the SPIRIT Checklist are attached as Additional file 1.

Innovations in vital signs measurement for the detection of hypertension and shock in pregnancy

Approximately 820 women die in pregnancy and childbirth every day worldwide, with 99% of these occurring in low-resource settings. The most common causes of maternal mortality are haemorrhage, sepsis and hypertensive disorders. There are established, effective solutions to these complications, however challenges remain in identifying who is at greatest risk and ensuring that interventions are delivered early when they have the greatest potential to benefit. Measuring vital signs is the first step in identifying women at risk. Overstretched or poorly trained staff and inadequate access to accurate, reliable equipment to measure vital signs can potentially result in delayed treatment initiation. Early warning systems may help alert users to identify patients at risk, especially where novel technologies can improve usability by automating calculations and alerting users to abnormalities. This may be of greatest benefit in under-resourced settings where task-sharing is common and early identification of complications can allow for prioritisation of life-saving interventions. This paper highlights the challenges of accurate vital sign measurement in pregnancy and identifies innovations which may improve detection of pregnancy complications.

Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings

Objectives Haemorrhage, hypertension, sepsis and abortion complications (often from haemorrhage or sepsis) contribute to 60% of all maternal deaths. Each is associated with vital signs (blood pressure (BP) and pulse) abnormalities, and the majority of deaths are preventable through simple and timely intervention. This paper presents the development and evaluation of the CRADLE Vital Signs Alert (VSA), an accurate, low-cost and easy-to-use device measuring BP and pulse with an integrated traffic light early warning system. The VSA was designed to be used by all cadres of healthcare providers for pregnant women in low-resource settings with the aim to prevent avoidable maternal mortality and morbidity. Methods The development and the mixed-methods clinical evaluation of the VSA are described. Results Preliminary fieldwork identified that introduction of BP devices to rural clinics improved antenatal surveillance of BP in pregnant women. The aesthetics of the integrated traffic light system were developed through iterative qualitative evaluation. The traffic lights trigger according to evidence-based vital sign thresholds in hypertension and haemodynamic compromise from haemorrhage and sepsis. The VSA can be reliably used as an auscultatory device, as well as its primary semiautomated function, and is suitable as a self-monitor used by pregnant women. Conclusion The VSA is an accurate device incorporating an evidence-based traffic light early warning system. It is designed to ensure suitability for healthcare providers with limited training and may improve care for women in pregnancy, childbirth and in the postnatal period.