Instruments for assisted vaginal birth.

BACKGROUND: Assisted vaginal births are carried out to expedite birth for the benefit of mothers and babies but are sometimes associated with significant morbidity for both. Various instruments are available, broadly divided into forceps and vacuum cups, and choice may be influenced by clinical circumstances, operator preference, experience and availability.  OBJECTIVES: To evaluate the different instruments in terms of success in achieving a vaginal birth, and the risk of morbidity for mother and baby. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (14 May 2021), and reference lists of retrieved studies. SELECTION CRITERIA: We selected randomised controlled trials of assisted vaginal birth using different instruments. The review did not include quasi-randomised trials, cluster-randomised trials or cross-over designs. The review included trials for which abstracts alone were available as long as there was sufficient information to assess eligibility.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We used the GRADE approach to assess the certainty of evidence.  The main outcomes assessed included failed delivery with allocated instrument, any maternal trauma, third- and fourth-degree tears, postpartum haemorrhage, any neonatal trauma, low Apgar and low umbilical artery pH.  MAIN RESULTS: We included 31 studies involving a total of 5754 women.  Risk of bias criteria were largely assessed as 'unclear', due to a lack of detail in trial reports. Blinding would have been challenging for all trials due to their inability to conceal the type of instrument used from either the woman or the operator, which is reflected in the risk of bias assessment. Any type of forceps versus any type of vacuum cup (12 studies, 3129 women) Forceps may be less likely to fail in achieving vaginal birth: risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.88; 11 studies, 3080 women; low certainty. 'Any maternal trauma' may be slightly more likely with forceps: odds ratio (OR) 1.53, 95% CI 0.98 to 2.40; 5 studies, 1356 women; low certainty; and third- or fourth-degree tears may also be more likely with forceps: RR 1.83, 95% CI 1.32 to 2.55; 9 studies, 2493 women; low certainty. There is no evidence of a difference in the incidence of postpartum haemorrhage (PPH) between the two groups: RR 1.71, 95% CI 0.59 to 4.95; 2 studies, 523 women; low certainty, because the evidence is very imprecise due to a very wide CI.  More women in the forceps group reported requiring pain relief. There is probably no evidence of difference in rates of low Apgar: RR 0.83, 95% CI 0.46 to 1.51; 7 studies, 1644 women; moderate certainty; or low umbilical artery pH in the forceps group compared to any vacuum: RR 1.33, 95% CI 0.91 to 1.93; 2 studies, 789 women; low certainty; both of these outcomes are imprecise and have wide CIs that include both benefit and harm. There were also lower rates of fetal trauma with 'any forceps' (cephalhematoma, retinal haemorrhage and jaundice). The composite outcome of 'any neonatal trauma' was not reported. Low-cavity forceps versus any vacuum cup (2 studies, 218 women) We included two small studies with 218 participants in this comparison, but we judged most of the evidence as very low certainty, hence it was not feasible to make judgements on the difference in the rates of failed delivery, any maternal trauma or third- and fourth- degree tears. PPH and low umbilical artery pH were not reported. Soft vacuum cup versus any rigid cup (9 studies, 1148 women) Failed delivery may be more likely in the soft vacuum cup group: RR 1.62, 95% CI 1.21 to 2.17; 9 studies, 1148 women; low certainty. There may be no difference in the rates of 'any maternal trauma': OR 0.63, 95% CI 0.24 to 1.67; 2 studies, 348 women; low certainty, but the confidence interval is wide, indicating possible benefit or harm. There may be no difference in the rates of third- or fourth-degree tears: RR 0.93, 95% CI 0.35 to 2.44; 4 studies, 619 women; low certainty. There is probably no difference in the rates of PPH: RR 0.89, 95% CI 0.49 to 1.61; 5 studies, 737 women; moderate certainty between the soft and rigid cup groups.   There may be little or no difference in the incidence of low Apgar scores: RR 0.82, 95% CI 0.49 to 1.37; 9 studies, 1148; low certainty; or low umbilical artery pH: RR 0.80, 95% CI 0.47 to 1.36; 1 study, 100 women; low certainty. Handheld vacuum versus any vacuum cup (4 studies, 968 women) There may be no difference in the rates of failures with allocated instrument: RR 1.35, 95% CI 0.81 to 2.25; 4 studies, 962 women; low certainty, any maternal trauma: OR 1.16, 95% CI 0.71 to 1.88; 2 studies; 394 women; low certainty, PPH: RR 0.31, 95% CI 0.03 to 2.92; 1 study, 164 women; low certainty, low umbilical artery pH: RR 1.06, 95% CI 0.71 to 1.59; 1 study, 164 women; low certainty, or low Apgar scores: RR 1.25, 95% CI 0.34 to 4.61; 3 studies, 784 women; low certainty) between the two groups. There is probably no difference in the rates of third- or fourth-degree tears between the 'handheld vacuum' and 'any vacuum cup' groups: RR 1.15, 95% CI 0.62 to 2.12; 4 studies, 962 women; moderate certainty. AUTHORS' CONCLUSIONS: This review provides low-certainty evidence that forceps may be more likely to achieve vaginal birth and have lower rates of fetal trauma, but at a greater risk of perineal trauma and higher pain relief requirements compared with vacuum cups. There was low-certainty evidence that rigid vacuum cups may be more likely to achieve a vaginal birth than soft cups but with more fetal trauma, whilst handheld vacuum cups had similar success rates compared to other cups. There was no evidence of a difference in the rates of third- or fourth-degree tears or postpartum haemorrhages between types of cups, but wide confidence intervals around the estimates indicate further research is needed in this area.

Non-contraceptive oestrogen-containing preparations for controlling symptoms of premenstrual syndrome.

BACKGROUND: Premenstrual syndrome (PMS) is a psychological and somatic disorder of unknown aetiology, with symptoms typically including irritability, depression, mood swings, bloating, breast tenderness and sleep disturbances. About 3% to 10% of women who experience these symptoms may also meet criteria for premenstrual dysphoric disorder (PMDD). PMS symptoms recur during the luteal phase of the menstrual cycle and reduce by the end of menstruation. PMS results from ovulation and may be due to ovarian steroid interactions relating to neurotransmitter dysfunction. Premenstrual disorders have a devastating effect on women, their families and their work.Several treatment options have been suggested for PMS, including pharmacological and surgical interventions. The treatments thought to be most effective tend to fall into one of two categories: suppressing ovulation or correcting a speculated neuroendocrine anomaly.Transdermal oestradiol by patch, gel or implant effectively stops ovulation and the cyclical hormonal changes which produce the cyclical symptoms. These preparations are normally used for hormone therapy and contain lower doses of oestrogen than found in oral contraceptive pills. A shortened seven-day course of a progestogen is required each month for endometrial protection but can reproduce premenstrual syndrome-type symptoms in these women. OBJECTIVES: To determine the effectiveness and safety of non-contraceptive oestrogen-containing preparations in the management of PMS. SEARCH METHODS: On 14 March 2016, we searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register; Cochrane Central Register of Studies (CRSO); MEDLINE; Embase; PsycINFO; CINAHL; ClinicalTrials.gov; metaRegister of Controlled trials (mRCT); and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal. In addition, we checked the reference lists of articles retrieved. SELECTION CRITERIA: We included published and unpublished randomized placebo or active controlled trials on the efficacy of the use of non-contraceptive oestrogen-containing preparations in the management of premenstrual syndrome in women of reproductive age with PMS diagnosed by at least two prospective cycles without current psychiatric disorder. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, extracted data on premenstrual symptoms and adverse effects and entered data into Review Manager 5 software. Where possible, intention-to-treat or modified intention-to-treat analysis was used. Studies were pooled using a fixed-effect model, analysing cross-over trials as parallel trials. Standardised mean differences (SMDs) with 95% confidence intervals (CIs) were calculated for premenstrual symptom scores. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes. The overall quality of the evidence was assessed using the GRADE working group methods. MAIN RESULTS: The search resulted in 524 potentially relevant articles. Five eligible randomized controlled trials (RCTs) were identified (305 women). Trials using oral tablets, transdermal patches and implants were identified. No trial used gels.One small cross-over trial (11 women, effective sample size 22 women considering cross-over trials) compared oral luteal-phase oestrogen versus placebo. Data were very low quality and unsuitable for analysis, but study authors reported that the intervention was ineffective and might aggravate the symptoms of PMS. They also reported that there were no adverse events.Three studies compared continuous oestrogen with progestogen versus placebo (with or without progestogen). These trials were of reasonable quality, although with a high risk of attrition bias and an unclear risk of bias due to potential carry-over effects in two cross-over trials. Continuous oestrogen had a small to moderate positive effect on global symptom scores (SMD -0.34, 95% CI -0.59 to -0.10, P = 0.005, 3 RCTs, 158 women, effective sample size 267 women, I² = 63%, very low quality evidence). The evidence was too imprecise to determine if the groups differed in withdrawal rates due to adverse effects (RR 0.64, 95% CI 0.26 to 1.58, P = 0.33, 3 RCTs, 196 women, effective sample size 284 women, I² = 0%, very low quality evidence). Similarly, the evidence was very imprecise in measures of specific adverse events, with large uncertainties around the true value of the relative risk. None of the studies reported on long-term risks such as endometrial cancer or breast cancer.One study compared patch dosage (100 vs 200 µg oestrogen, with progestogen in both arms) and had a high risk of performance bias, detection bias and attrition bias. The study did not find evidence that dosage affects global symptoms but there was much uncertainty around the effect estimate (SMD -1.55, 95% CI -8.88 to 5.78, P = 0.68, 1 RCT, 98 women, very low quality evidence). The evidence on rates of withdrawal for adverse events was too imprecise to draw any conclusions (RR 0.70, 95% CI 0.34 to 1.46, P = 0.34, 1 RCT, 107 women, low-quality evidence). However, it appeared that the 100 µg dose might be associated with a lower overall risk of adverse events attributed to oestrogen (RR 0.51, 95% Cl 0.26 to 0.99, P = 0.05, 1 RCT, 107 women, very low quality evidence) with a large uncertainty around the effect estimate.The overall quality of the evidence for all comparisons was very low, mainly due to risk of bias (specifically attrition), imprecision, and statistical and clinical heterogeneity. AUTHORS' CONCLUSIONS: We found very low quality evidence to support the effectiveness of continuous oestrogen (transdermal patches or subcutaneous implants) plus progestogen, with a small to moderate effect size. We found very low quality evidence from a study based on 11 women to suggest that luteal-phase oral unopposed oestrogen is probably ineffective and possibly detrimental for controlling the symptoms of PMS. A comparison between 200 µg and 100 µg doses of continuous oestrogen was inconclusive with regard to effectiveness, but suggested that the lower dose was less likely to cause side effects. Uncertainty remains regarding safety, as the identified studies were too small to provide definite answers. Moreover, no included trial addressed adverse effects that might occur beyond the typical trial duration of 2-8 months. This suggests the choice of oestrogen dose and mode of administration could be based on an individual woman's preference and modified according to the effectiveness and tolerability of the chosen regimen.

A dedicated undergraduate gynaecology teaching clinic: The Keele experience.

Much discussion in the literature centres on how best to teach medical students the intricacies of gynaecological assessment and the subsequent formulation of a management plan. At Keele University skills are initially developed in a simulated setting and then transferred to the workplace where students continue to develop their skills. A dedicated undergraduate gynaecology teaching clinic has been developed and comprises of 2-3 students and a tutor. All 38 students rotating through the department between January and June 2013 were invited to complete an anonymous questionnaire to evaluate this clinic and 36 (95%) of them responded. Respondents felt significantly more comfortable taking a gynaecology history, ensuring privacy during examination and formulating a management plan post-clinic (all p < 0.001), with female students feeling significantly more comfortable than their male counterparts (p = 0.04). The use of this clinic shows great promise to help students learn an unfamiliar and challenging skill.

Development and face validation of strategies for improving consultation skills.

While formative workplace based assessment can improve learners' skills, it often does not because the procedures used do not facilitate feedback which is sufficiently specific to scaffold improvement. Provision of pre-formulated strategies to address predicted learning needs has potential to improve the quality and automate the provision of written feedback. To systematically develop, validate and maximise the utility of a comprehensive list of strategies for improvement of consultation skills through a process involving both medical students and their clinical primary and secondary care tutors. Modified Delphi study with tutors, modified nominal group study with students with moderation of outputs by consensus round table discussion by the authors. 35 hospital and 21 GP tutors participated in the Delphi study and contributed 153 new or modified strategies. After review of these and the 205 original strategies, 265 strategies entered the nominal group study to which 46 year four and five students contributed, resulting in the final list of 249 validated strategies. We have developed a valid and comprehensive set of strategies which are considered useful by medical students. This list can be immediately applied by any school which uses the Calgary Cambridge Framework to inform the content of formative feedback on consultation skills. We consider that the list could also be mapped to alternative skills frameworks and so be utilised by schools which do not use the Calgary Cambridge Framework.

Unusual presentation of a septate hymen leading to a retained vaginal tampon in the urinary bladder.

There is a wide range of hymenal variants which exist and usually become apparent to women during puberty. Our case describes a 16-year-old woman with a previously undiagnosed hymenal septum who presented with a retained tampon within the urinary bladder. This case report discusses a rare presentation of a hymenal variant and highlights the importance of understanding the difference in pelvic examinations in children and adolescents when compared with adults and awareness of the different hymenal variants.

Choice of instruments for assisted vaginal delivery.

BACKGROUND: Instrumental or assisted vaginal birth is commonly used to expedite birth for the benefit of either mother or baby or both. It is sometimes associated with significant complications for both mother and baby. The choice of instrument may be influenced by clinical circumstances, operator choice and availability of specific instruments. OBJECTIVES: To evaluate different instruments in terms of achieving a vaginal birth and avoiding significant morbidity for mother and baby. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2010). SELECTION CRITERIA: Randomised controlled trials of assisted vaginal delivery using different instruments. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality, extracted the data, and checked them for accuracy. MAIN RESULTS: We included 32 studies (6597 women) in this review. Forceps were less likely than the ventouse to fail to achieve a vaginal birth with the allocated instrument (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.45 to 0.94). However, with forceps there was a trend to more caesarean sections, and significantly more third- or fourth-degree tears (with or without episiotomy), vaginal trauma, use of general anaesthesia, and flatus incontinence or altered continence. Facial injury was more likely with forceps (RR 5.10, 95% CI 1.12 to 23.25). Using a random-effects model because of heterogeneity between studies, there was a trend towards fewer cases of cephalhaematoma with forceps (average RR 0.64, 95% CI 0.37 to 1.11).Among different types of ventouse, the metal cup was more likely to result in a successful vaginal birth than the soft cup, with more cases of scalp injury and cephalhaematoma. The hand-held ventouse was associated with more failures than the metal ventouse, and a trend to fewer than the soft ventouse.Overall forceps or the metal cup appear to be most effective at achieving a vaginal birth, but with increased risk of maternal trauma with forceps and neonatal trauma with the metal cup. AUTHORS' CONCLUSIONS: There is a recognised place for forceps and all types of ventouse in clinical practice. The role of operator training with any choice of instrument must be emphasised. The increasing risks of failed delivery with the chosen instrument from forceps to metal cup to hand-held to soft cup vacuum, and trade-offs between risks of maternal and neonatal trauma identified in this review need to be considered when choosing an instrument.

Estimation of proteinuria as a predictor of complications of pre-eclampsia: a systematic review.

BACKGROUND: Proteinuria is one of the essential criteria for the clinical diagnosis of pre-eclampsia. Increasing levels of proteinuria is considered to be associated with adverse maternal and fetal outcomes. We aim to determine the accuracy with which the amount of proteinuria predicts maternal and fetal complications in women with pre-eclampsia by systematic quantitative review of test accuracy studies. METHODS: We conducted electronic searches in MEDLINE (1951 to 2007), EMBASE (1980 to 2007), the Cochrane Library (2007) and the MEDION database to identify relevant articles and hand-search of selected specialist journals and reference lists of articles. There were no language restrictions for any of these searches. Two reviewers independently selected those articles in which the accuracy of proteinuria estimate was evaluated to predict maternal and fetal complications of pre-eclampsia. Data were extracted on study characteristics, quality and accuracy to construct 2 x 2 tables with maternal and fetal complications as reference standards. RESULTS: Sixteen primary articles with a total of 6749 women met the selection criteria with levels of proteinuria estimated by urine dipstick, 24-hour urine proteinuria or urine protein:creatinine ratio as a predictor of complications of pre-eclampsia. All 10 studies predicting maternal outcomes showed that proteinuria is a poor predictor of maternal complications in women with pre-eclampsia. Seventeen studies used laboratory analysis and eight studies bedside analysis to assess the accuracy of proteinuria in predicting fetal and neonatal complications. Summary likelihood ratios of positive and negative tests for the threshold level of 5 g/24 h were 2.0 (95% CI 1.5, 2.7) and 0.53 (95% CI 0.27, 1) for stillbirths, 1.5 (95% CI 0.94, 2.4) and 0.73 (95% CI 0.39, 1.4) for neonatal deaths and 1.5 (95% 1, 2) and 0.78 (95% 0.64, 0.95) for Neonatal Intensive Care Unit admission. CONCLUSION: Measure of proteinuria is a poor predictor of either maternal or fetal complications in women with pre-eclampsia.

Tests for predicting complications of pre-eclampsia: a protocol for systematic reviews.

BACKGROUND: Pre-eclampsia is associated with several complications. Early prediction of complications and timely management is needed for clinical care of these patients to avert fetal and maternal mortality and morbidity. There is a need to identify best testing strategies in pre eclampsia to identify the women at increased risk of complications. We aim to determine the accuracy of various tests to predict complications of pre-eclampsia by systematic quantitative reviews. METHOD: We performed extensive search in MEDLINE (1951-2004), EMBASE (1974-2004) and also will also include manual searches of bibliographies of primary and review articles. An initial search has revealed 19500 citations. Two reviewers will independently select studies and extract data on study characteristics, quality and accuracy. Accuracy data will be used to construct 2 x 2 tables. Data synthesis will involve assessment for heterogeneity and appropriately pooling of results to produce summary Receiver Operating Characteristics (ROC) curve and summary likelihood ratios. DISCUSSION: This review will generate predictive information and integrate that with therapeutic effectiveness to determine the absolute benefit and harm of available therapy in reducing complications in women with pre-eclampsia.

Development of a clockwork light source to enable cervical inspection by village health workers.

BACKGROUND: Cervical cancer can often be prevented by screening and may be curable if identified and treated in its early stages. However, 80% of new cases occur in less-developed countries where cervical cancer screening programmes are small-scale or non-existent. This is a human tragedy of great proportion, with many of those affected being young mothers. There is some evidence that cancerous or precancerous lesions may be detected by visual inspection with acetic acid (VIA) and field studies indicate that this technique is effective, safe and acceptable to women. However, the provision of a light source for inspection of the cervix presents a major problem in less-developed countries, where candles and torches often provide the only means of illumination. Our objective was to develop a light source based on clockwork technology, that required no batteries or external power source. METHODS: We adapted the design of a commercially available clockwork torch to provide a light source for cervical inspection. The light source was then tested under laboratory conditions in a comparison with other illumination methods typically used in this application. RESULTS: The light source gave illuminance levels greater than those produced by any other method tested, and also had considerable advantages in terms of ease of use and safety. CONCLUSION: This design is small, compact, effective and safe to use and promises a better and more affordable means of visualising the cervix. Further field trials of VIA are now required which incorporate this light source.

Training tomorrow's doctors in the preoperative clinic.

BACKGROUND: The reduction in the length of hospital stay for surgical patients at a time of expanding medical student numbers has created challenges in the provision of adequate exposure to surgical patients. This has required the use of surgical learning opportunities in the ambulatory setting, including the preoperative assessment clinic. At Keele University, fourth-year medical students follow patient journeys through the preoperative assessment process, gaining experience of history taking, examination, prescribing and practical skills. This is followed by group discussion with a clinical teaching fellow, focusing on management and clinical reasoning. We audited the experience our students gained in the preoperative assessment clinic against the relevant Tomorrow's Doctors outcomes. METHODS: An audit tool was created by reviewing the patient journey to identify potential learning opportunities. These were then mapped to the relevant Tomorrow's Doctors outcomes. Audit pro formas were completed for each student at the end of the clinic by the clinical educator, with a total of 42 sessions audited. RESULTS: Our findings show that it is possible for students to gain experience in all nine of the identified Tomorrow's Doctors outcomes in the preoperative assessment clinic. Practical procedure experience was gained by 92 per cent of students, and 70 per cent demonstrated clinical judgment and decision skills. DISCUSSION: This study shows that students can gain experience in multiple Tomorrow's Doctors outcomes in the preoperative assessment clinic. In particular, it is a useful environment to learn and teach practical procedures, clinical reasoning and decision-making skills.

Review of singleton fetal and neonatal deaths associated with cranial trauma and cephalic delivery during a national intrapartum-related confidential enquiry.

OBJECTIVE: To review delivery details of intrapartum-related fetal and neonatal deaths with singleton cephalic presentation and birthweight of 2500 g or more in which traumatic cranial or cervical spine injury or substantial difficulty at delivery of the head was a dominant feature. DESIGN: Review of freestyle summary reports and standard questionnaire responses submitted to the national secretariat for the Confidential Enquiry into Stillbirths and Death in Infancy (CESDI) during the 1994/1995 intrapartum-related mortality enquiry following regional multidisciplinary panel review. SETTING: United Kingdom. SAMPLE: Of the 873 cases of intrapartum-related deaths reported in the 1994-1995 national enquiry, 709 weighed more than 2499 g. REPORTS: from 181 (89 from 1994 and 92 from 1995) with a chance of meeting criteria for cranial or cervical trauma as significant contributors to death were examined in detail. Thirty-seven were judged to meet the criteria stated in the objectives (23 from 1994 and 14 from 1995) and form the basis for this review. METHODS: Electronic and hand search of CESDI records relating to intrapartum-related deaths. MAIN OUTCOME MEASURES: Intrapartum events and features of care. RESULTS: There was evidence of fetal compromise present before birth in 33 of the 37 (89%) study group cases reviewed. One delivery was performed vaginally without instrumentation, and in one there was no attempt at vaginal delivery before caesarean section (CS) in the second stage of labour. Twenty-four cases (65%) were delivered vaginally and 11 (30%) by CS after failure to deliver vaginally with instruments. A single instrument was used in six cases of vaginal delivery (four ventouse and two Kjelland's forceps). At least two separate attempts with different instruments were made in 24 cases. Overall, the ventouse was used in 27 cases and forceps in 29 cases. In six cases, three separate attempts were made with at least two different instruments, all of which included use of ventouse. The grade of operator was recorded in 27 cases. Of these, a consultant obstetrician was present at only one delivery and no consultant was recorded to have made the first attempt to deliver a baby. In six cases, shoulder dystocia was also reported. CONCLUSIONS: This study suggests a lower incidence of death from difficult cephalic delivery and cranial trauma than previously reported. The CESDI studies were believed to have achieved high levels of ascertainment for all intrapartum-related deaths from which the cases reported here were selected. Strictly applied entry criteria used in this study could have restricted the number of cases considered as could limited in vivo or postmortem investigations and lack of detailed autopsy. When cranial traumatic injury was observed, it was almost always associated with physical difficulty at delivery and the use of instruments. The use of ventouse as the primary or only instrument did not prevent this outcome. Some injuries occurred apparently without evidence of unreasonable force, but poorly judged persistence with attempts at vaginal delivery in the presence of failure to progress or signs of fetal compromise were the main contributory factor regardless of which instruments were used.