Experiences of Impacted Foetal Head: Findings from a Pragmatic Focus Group Study of Mothers and Midwives.

INTRODUCTION: We aimed to explore the lived experiences of caesarean birth complicated by impaction of the foetal head, for mothers and midwives. METHODS: A pragmatic, qualitative, focus group study of mixed-participants was conducted, face-to-face. They were postpartum women (n = 4), midwives (n = 4), and a postpartum midwife (n = 1) who had experience of either providing care for impacted foetal head, and/or had experienced it during their own labour, in Fife, United Kingdom. Data were transcribed and were analysed using template analysis. RESULTS: Three main themes emerged through analysis: (i) current knowledge of impacted foetal head; (ii) current management of impacted foetal head; and (iii) experiences and outcomes of impacted foetal head. Each theme was made up of various initial codes when data were analysed inductively. Finally, each theme could be overlaid onto the three core principles of the Tydeman Tube: (1) to improve outcomes for mother and baby in the second stage of labour; (2) to reduce the risk of trauma to mother and baby in complicated births; and (3) to increase respectful care for women in labour; thus allowing for a neat analytic template. CONCLUSION: A lack of consensus regarding definition, management, and training were highlighted by the midwives. Women anticipated caesarean birth in late labour as straightforward and were therefore unaware of this potential complication. Women and midwives would welcome any new device to facilitate delivery of the impacted foetal head (IFH) as long as it is fully evaluated prior to widespread introduction. Women were not averse to being part of this evaluation process.

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.

Cervical cerclage technique: what do experts actually achieve?

BACKGROUND: Cervical cerclage is a recognized intervention in the management of women at risk of preterm birth and midtrimester loss. The mechanism of action of cerclage is unclear, and the technique has been poorly researched. OBJECTIVE: This study aimed to evaluate cerclage technique among experienced obstetricians, using a previously developed and evaluated cerclage simulator. STUDY DESIGN: This prospective experimental simulation and observational study used identical simulators for 28 consultant obstetricians who were asked to perform their normal cerclage. Suture type, height, knot site, and free thread length were recorded. Using computed tomography, depth of bite and tension (by reduction in area of cervix) were calculated. RESULTS: A total of 52 cervical cerclages were completed (Mersilene tape, n=20; monofilament suture, n=32). Mean suture height was 33 mm (standard deviation, 7.7 mm), greater with monofilament suture than with Mersilene tape, and associated with smaller needle size. Mean depth of bite and mean reduction of starting area did not differ by suture type. Seven procedures showed ≥1 suture bite that had entered the cervical canal once or more. CONCLUSION: This study assessed cerclage technique of experienced obstetricians using simulators and computed tomography imaging, and demonstrated wide variation in technique; this may affect the efficacy of the procedure. Further work should establish optimal technique and consensus for training and clinical practice.

Cervical cerclage training: Development and assessment of a simulator.

BACKGROUND: Cervical cerclage is a mainstay intervention for the prevention of spontaneous preterm birth in high-risk women. Simulation training facilitates high-level skill transfer in a low-consequence environment, and is being integrated into obstetrics and gynecology training. OBJECTIVE: This study aimed to develop a simulator for cervical cerclage, determine its validity as a simulator, and identify parameters suitable as proxy markers for performance. STUDY DESIGN: The 3 aims of this study were achieved, namely: (1) simulator design by obstetricians and a commercial company; (2) survey of obstetricians and gynecologists across a variety of training stages to determine need for and opinion of the simulator; and (3) comparison of novice and expert groups across a variety of proxy markers for successful cerclage insertion. RESULTS: Obstetricians and gynecologists found the simulator to be similar to clinical scenarios and suitable for skill training. Novice participants stated that the use of the simulator improved their confidence (P=.016). In a comparison between 6 expert and 8 novice surgeons, there seemed to be variations across multiple measurements of cerclage placement. CONCLUSION: Simulation is an increasingly prominent training modality for surgical skills. The simulator described herein was considered suitable for training by obstetricians and gynecologists. Further work should focus on the validations of proxy markers of successful insertion, longitudinal assessment of trainees, and correlation of training outcomes with clinical outcomes.

A comparison of technicques to disimpact the fetal head on a second stage caesearean simulator.

BACKGROUND: The rate of second stage caesarean section (CS) is rising with associated increases in maternal and neonatal morbidity, which may be related to impaction of the fetal head in the maternal pelvis. In the last 10 years, two devices have been developed to aid disimpaction and reduce these risks: the Fetal Pillow (FP) and the Tydeman Tube (TT). The aim of this study was to determine the distance of upward fetal head elevation achieved on a simulator for second stage CS using these two devices, compared to the established technique of per vaginum digital disimpaction by an assistant. METHODS: We measured elevation of the fetal head achieved with the two devices (TT and FP), compared to digital elevation, on a second stage Caesearean simulator (Desperate Debra ™ set at three levels of severity. Elevation was measured by both a single operator experienced with use of the TT and FP and also multiple assistants with no previous experience of using either device. All measurements were blinded RESULTS: The trained user achieved greater elevation of the fetal head at both moderate and high levels of severity with the TT (moderate: 30mm vs 12.5mm p<0.001; most severe: 25mm vs 10mm p<0.001) compared to digital elevation. The FP provided comparable elevation to digital at both settings (moderate: 10 vs 12.5mm p=0.149; severe 10 vs 10mm p=0.44). With untrained users, elevation was also significantly greater with the TT compared to digital elevation (20mm vs 10mm p<0.01). However digital disimpaction was significantly greater than the FP (10mm vs 0mm p<0.0001). CONCLUSION: On a simulator, with trained operators, the TT provided greater fetal head elevation than digital elevation and the FP. The FP achieved similar elevation to the digital technique, especially when the user was trained in the procedure.

MAVRIC: a multicenter randomized controlled trial of transabdominal vs transvaginal cervical cerclage.

BACKGROUND: Vaginal cerclage (a suture around the cervix) commonly is placed in women with recurrent pregnancy loss. These women may experience late miscarriage or extreme preterm delivery, despite being treated with cerclage. Transabdominal cerclage has been advocated after failed cerclage, although its efficacy is unproved by randomized controlled trial. OBJECTIVE: The objective of this study was to compare transabdominal cerclage or high vaginal cerclage with low vaginal cerclage in women with a history of failed cerclage. Our primary outcome was delivery at <32 completed weeks of pregnancy. STUDY DESIGN: This was a multicenter randomized controlled trial. Women were assigned randomly (1:1:1) to receive transabdominal cerclage, high vaginal cerclage, or low vaginal cerclage either before conception or at <14 weeks of gestation. RESULTS: The data for 111 of 139 women who were recruited and who conceived were analyzed: 39 had transabdominal cerclage; 39 had high vaginal cerclage, and 33 had low vaginal cerclage. Rates of preterm birth at <32 weeks of gestation were significantly lower in women who received transabdominal cerclage compared with low vaginal cerclage (8% [3/39] vs 33% [11/33]; relative risk, 0.23; 95% confidence interval, 0.07-0.76; P=.0157). The number needed to treat to prevent 1 preterm birth was 3.9 (95% confidence interval, 2.32-12.1). There was no difference in preterm birth rates between high and low vaginal cerclage (38% [15/39] vs 33% [11/33]; relative risk, 1.15; 95% confidence interval, 0.62-2.16; P=.81). No neonatal deaths occurred. In an exploratory analysis, women with transabdominal cerclage had fewer fetal losses compared with low vaginal cerclage (3% [1/39] vs 21% [7/33]; relative risk, 0.12; 95% confidence interval, 0.016-0.93; P=.02). The number needed to treat to prevent 1 fetal loss was 5.3 (95% confidence interval, 2.9-26). CONCLUSION: Transabdominal cerclage is the treatment of choice for women with failed vaginal cerclage. It is superior to low vaginal cerclage in the reduction of risk of early preterm birth and fetal loss in women with previous failed vaginal cerclage. High vaginal cerclage does not confer this benefit. The numbers needed to treat are sufficiently low to justify transabdominal surgery and cesarean delivery required in this select cohort.

The impacted foetal head at caesarean section: incidence and techniques used in a single UK institution.

An impaction of the foetal head at caesarean section is a topical concern in modern obstetric practice. The management options for this problem are well described but the incidence or even definition of impaction, is unknown. The primary aim of this study was to ascertain the incidence of impacted foetal head at CS in labour. This prospective study used data from all women undergoing CS during a 12-month period in a single unit. Following completion of all CS, the surgeon completed a questionnaire covering: cervical dilation at time of CS; if the surgeon felt there was a difficulty in delivering the foetal head as an indicator of impaction, as well as the other techniques utilised. Of 440 EMCS in labour, 18% (n = 81) reported a difficulty delivering the head, which was most common at cervical dilation ≥8 cm (n = 124, 48%). A difficulty with the delivery of the foetal head was associated with 36% increased measured blood loss. Impact statement What is already known on this subject? Impaction of the foetal head at a caesarean section is a recognised complication of CS in late labour but there are no reliable data on the incidence of the problem. It is poorly defined and yet many techniques and devices have been described to overcome this problem, however, optimal management remains uncertain. What do the results of this study add? The primary aim of this study was to determine the incidence of the impacted foetal head during CS in labour as determined by whether the surgeon experienced difficulty with delivery of the head. We report that at least some difficulty in delivering the foetal head at CS is common, and most often encountered when cervical dilation is ≥8 cm. When additional manoeuvres were required, the 'push' technique was exclusively adopted with implications for training. A difficulty in delivering the foetal head was associated with a 36% increase in the measured maternal blood loss. What are the implications of these findings for clinical practice and/or further research? Further multi-centre investigation is required to ascertain incidence of this obstetric problem with predicting factors determined. This work will inform decisions about the optimal management.

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

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.

DNA copy number variations are important in the complex genetic architecture of müllerian disorders.

OBJECTIVE: To clinically and genetically investigate women with müllerian disorders, including Mayer-Rokitanksy-Kuster-Hauser (MRKH) syndrome. DESIGN: Two-year prospective clinical and laboratory study. SETTING: Not applicable. PATIENT(S): Thirty-five women over 16 years of age with a müllerian disorder, including MRKH. INTERVENTION(S): Women were recruited from specialist gynecology clinics or identified from the Scottish Disorders of Sex Development Register (www.sdsd.scot.nhs.uk/index.html). Associated abnormalities were detected by clinical examination, imaging studies, and biochemical analyses. Chromosomal microduplications and microdeletions were detected by array comparative genomic hybridization (CGH) and validated by fluorescence in situ hydridization. MAIN OUTCOME MEASURE(S): Identification of associated congenital and biochemical abnormalities and identification of regions of genomic imbalance using array CGH. RESULT(S): Associated congenital anomalies were common, present in 25/35 (71%) of affected women, particularly renal and skeletal abnormalities, which were present in 15/35 (43%) and 17/35 (49%) women, respectively. Using array CGH, novel or recurrent regions of genomic imbalance were identified in 4/11 (36%) women with MRKH and in 5/24 (21%) women with other müllerian abnormalities. CONCLUSION(S): Additional congenital abnormalities and regions of genomic imbalance are common in women with müllerian disorders, including MRKH. Recurrent microdeletions and microduplications associated with MRKH implicate specific possibly causative genes. The investigation of women with müllerian disorders should be thorough, and array CGH should be considered, given the potential highly significant familial implications of a chromosomal abnormality.

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.

Stability of inhibin A and unconjugated oestriol in the second trimester of pregnancy.

BACKGROUND: The introduction of a second trimester quadruple test for fetal Down's syndrome adds the measurement of serum inhibin A (InhA) and unconjugated oestriol (UE3) to the existing repertoire of alphafetoprotein and intact human chorionic gonadotrophin. The aim of this study was to assess the stability of InhA and UE3 in whole blood and serum. METHODS: To determine whole blood stability, five extra blood specimens were obtained from each of 10 women attending an antenatal clinic. Samples were stored at room temperature for either two hours, one, three, five or seven days and centrifuged prior to analysis. Serum stability was studied by the analysis of surplus serum from 14 routine second trimester screening samples: seven stored at room temperature and seven stored at 4°C. An aliquot from each specimen was analysed two hours, one, three, five or seven days post centrifugation. Specimens were analysed for InhA and UE3 using the Beckman Access 2(®) Immunoassay analyser. RESULTS: No significant difference (P > 0.05) was shown in InhA or UE3 concentrations between the initial time point on the day of venepuncture and each of the subsequent analyses at one, three, five and seven days following collection for either whole blood or serum. CONCLUSIONS: InhA and UE3 are stable in whole blood and serum for seven days.

Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis.

BACKGROUND: Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. METHODS: In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581. FINDINGS: Three participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24.7% (61/247) in the progesterone group and 19.4% (48/247) in the placebo group (odds ratio [OR] 1.36, 95% CI 0.89-2.09; p=0.16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1.16, 95% CI 0.89-1.51). INTERPRETATION: Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy. FUNDING: Chief Scientist Office of the Scottish Government Health Directorate.

PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.

OBJECTIVES: The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting. DESIGN: A multicentre randomised controlled trial (RCT). SETTING: Fetal medicine units. POPULATION: Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO). METHODS: Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant. MAIN OUTCOME MEASURES: The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant. FUNDING: Wellbeing of Women. ESTIMATED COMPLETION DATE: September 2010. TRIAL ALGORITHM: [flowchart: see text].