Impact of electronic and blended learning programs for manual perineal support on incidence of obstetric anal sphincter injuries: a prospective interventional study.

BACKGROUND: Obstetric anal sphincter injuries (OASIS) are associated with anal incontinence, dyspareunia and perineal pain. Bimanual perineal support technique (bPST) prevents OASIS. The aim of this study was to assess the effect of two different bPST training-methods on OASIS incidence. METHODS: This is a prospective-interventional quality improvement study conducted in two Palestinian maternity units between June 1 2015 and December 31 2016. Women having spontaneous or operative vaginal-delivery at ≥24 gestational-weeks or a birthweight of ≥1000 g (n = 1694) were recruited and examined vaginally and rectally immediately after vaginal birth by a trained assessor. Data on baseline OASIS incidence were collected during Phase-1 of the study. Subsequently, birth attendants in both maternity units were trained in bPST using two training modalities. A self-directed electronic-learning (e-learning) using an animated video was launched in phase-2 followed by a blended learning method (the animated e-learning video+ structured face-to-face training) in phase-3. OASIS incidence was monitored during phases-2 and 3. Variations in OASIS incidence between the three phases were assessed using Pearson-χ2-test (or Fisher's-Exact-test). The impact of each training-method on OASIS incidence was assessed using logistic-regression analysis. RESULTS: A total of 1694 women were included; 376 in phase-1, 626 in phase-2 and 692 in phase-3. Compared to Phase-1, OASIS incidence was reduced by 45% (12.2 to 6.7%, aOR: 0.56, CI; 0.35-0.91, p = 0.018) and 74% (12.2 to 3.2%, aOR, 0.29, CI; 0.17-0.50, p < 0.001) in phases-2 and 3, respectively. There was also a significant reduction in OASIS incidence by 52% from phase-2 to phase-3 (6.7% (42/626) to 3.2% (22/692), p = 0.003). These reductions reached statistical significance among parous-women only (aOR: 0.18, CI; 0.07-0.49, p = 0.001) after the first training method tested in phase-2. However, the reduction was significant among both primiparous (aOR: 0.39, CI; 0.21-0.74, p = 0.004) and parous-women (aOR: 0.11, CI; 0.04-0.32, p < 0.001) after implementing the blended learning method in phase-3. CONCLUSION: The animated e-learning video had a positive impact on reducing OASIS incidence. However, this reduction was enhanced by the use of a blended learning program combining both e- learning and face-to-face training modalities. STUDY REGISTRATION NUMBER: ClinicalTrialo.gov identifier: NCT02427854 , date: 28 April 2015.

Impact of subsequent birth and delivery mode for women with previous OASIS: systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) are serious complications of vaginal birth. In a pregnancy following OASIS women may be keen to avoid an elective caesarean section, yet cautious about pursuing another vaginal birth that may result in further damage to the pelvic floor and possible long-term anal incontinence. This review aimed to evaluate the impact of subsequent birth and its mode on anal incontinence (AI) and/or quality of life (QoL), for women with previous OASIS. METHODS: Searches of MEDLINE, EMBASE, CINAHL, and AMED from inception to February 2016 were undertaken with selection criteria of any study evaluating the effect of a subsequent birth on AI and/or QoL in women with previous OASIS. Where possible, data were extracted to populate 2 × 2 tables and allow meta-analysis relating to the impact of subsequent birth on AI and/or QoL. RESULTS: Twenty-seven non-randomised studies were included. Meta-analysis of 14 studies (977 women) did not demonstrate any significant associations between AI in women with previous OASIS and subsequent birth or its mode. Impact on QoL was reported in 12 studies (912 women); however, difference in outcome reporting precluded data meta-analysis. CONCLUSIONS: Comparisons of outcomes and effective synthesis were limited by sample size, quality and heterogeneity of the studies included. Consequently, the optimal mode of delivery for women with previous OASIS is still not known and better data are needed.

An obstetric sphincter injury risk identification system (OSIRIS): is this a clinically useful tool?

INTRODUCTION AND HYPOTHESIS: To establish the contribution of maternal, fetal and intrapartum factors to the risk of incidence of obstetric anal sphincter injuries (OASIS) and assess the feasibility of an OASIS risk prediction model based on variables available to clinicians prior to birth. METHODS: This was a population-based, retrospective cohort study using single-site data from the birth database of Aarhus University Hospital, Denmark. The participants were all women who had a singleton vaginal birth during the period 1989 to 2006. Univariate and multivariate logistic regression analyses were performed using multiple imputations for missing data and internally validated using bootstrap methods. The main outcome measures were the contributions of maternal, fetal and intrapartum events to the incidence of OASIS. RESULTS: A total of 71,469 women met the inclusion criteria, of whom 1,754 (2.45 %) sustained OASIS. In the multivariate analysis of variables known prior to birth, maternal age 20 - 30 years (OR 1.65, 95 % CI 1.44 - 1.89) and ≥30 years (OR 1.60, 95 % CI 1.39 - 1.85), occipitoposterior fetal position (OR 1.34, 95 % CI 1.06 - 1.70), induction/augmentation of labour (OR 1.46, 95 % CI 1.32 - 1.62), and suspected macrosomia (OR 2.20, 95 % CI 1.97 - 2.45) were independent significant predictors of OASIS, with increasing parity conferring a significant protective effect. The 'prebirth variable' model showed a 95 % sensitivity and a 24 % specificity in predicting OASIS with 1 % probability, and a 3 % sensitivity and a 99 % specificity in predicting OASIS with a 10 % probability. CONCLUSIONS: Our model identified several significant OASIS risk factors that are known prior to actual birth. The prognostic model shows potential for ruling out OASIS (high sensitivity with a low risk cut-off value), but is not useful for ruling in the event.

Implementation of guidelines for multidisciplinary team management of pregnancy in women with pre-existing diabetes or cardiac conditions: results from a UK national survey.

BACKGROUND: Despite numerous publications stating the importance of multidisciplinary care for women with pre-existing medical conditions, there is a lack of evidence regarding structure or processes of multidisciplinary working, nor impact on maternal or infant outcomes. This study aimed to evaluate the implementation of guidelines for multidisciplinary team (MDT) management in pregnant women with pre-existing diabetes or cardiac conditions. These conditions were selected as exemplars of increasingly common medical conditions in pregnancy for which MDT management is recommended to prevent or reduce adverse maternal and fetal outcomes. METHODS: National on-line survey sent to clinicians responsible for management or referral of women with pre-existing diabetes or cardiac conditions in UK National Health Service (NHS) maternity units. The survey comprised questions regarding the organisation of MDT management for women with pre-existing diabetes or cardiac conditions. Content was informed by national guidance. RESULTS: One hundred seventy-nine responses were received, covering all health regions in England (162 responses) and 17 responses from Scotland, Wales and Northern Ireland. 132 (74%) related to women with diabetes and 123 (69%) to women with cardiac conditions. MDT referral was reportedly standard practice in most hospitals, particularly for women with pre-existing diabetes (88% of responses vs. 63% for cardiac) but there was wide variation in relation to MDT membership, timing of referral and working practices. These inconsistencies were evident within and between maternity units across the UK. Reported membership was medically dominated and often in the absence of midwifery/nursing and other allied health professionals. Less than half of MDTs for women with diabetes met the recommendations for membership in national guidance, and although two thirds of MDTs for women with cardiac disease met the core recommendations for membership, most did not report having the extended members: midwives, neonatologists or intensivists. CONCLUSIONS: The wide diversity of organisational management for women with pre-existing diabetes or cardiac conditions is of concern and merits more detailed inquiry. Evidence is also required to support and better define the recommendations for MDT care.

Fourth consensus of the International Society for Premenstrual Disorders (ISPMD): auditable standards for diagnosis and management of premenstrual disorder.

Whilst professional bodies such as the Royal College and the American College of Obstetricians and Gynecologists have well-established standards for audit of management for most gynaecology disorders, such standards for premenstrual disorders (PMDs) have yet to be developed. The International Society of Premenstrual Disorders (ISPMD) has already published three consensus papers on PMDs covering areas that include definition, classification/quantification, clinical trial design and management (American College Obstetricians and Gynecologists 2011; Brown et al. in Cochrane Database Syst Rev 2:CD001396, 2009; Dickerson et al. in Am Fam Physician 67(8):1743-1752, 2003). In this fourth consensus of ISPMD, we aim to create a set of auditable standards for the clinical management of PMDs. All members of the original ISPMD consensus group were invited to submit one or more auditable standards to be eligible in the inclusion of the consensus. Ninety-five percent of members (18/19) responded with at least one auditable standard. A total of 66 auditable standards were received, which were returned to all group members who then ranked the standards in order of priority, before the results were collated. Proposed standards related to the diagnosis of PMDs identified the importance of obtaining an accurate history, that a symptom diary should be kept for 2 months prior to diagnosis and that symptom reporting demonstrates symptoms in the premenstrual phase of the menstrual cycle and relieved by menstruation. Regarding treatment, the most important standards were the use of selective serotonin reuptake inhibitors (SSRIs) as a first line treatment, an evidence-based approach to treatment and that SSRI side effects are properly explained to patients. A set of comprehensive standards to be used in the diagnosis and treatment of PMD has been established, for which PMD management can be audited against for standardised and improved care.

Perineal support and risk of obstetric anal sphincter injuries: a Delphi survey.

OBJECTIVE: To explore the views of a multidisciplinary group of experts and achieve consensus on the importance of perineal support in preventing obstetric anal sphincter injuries (OASIS). DESIGN: A three-generational Delphi survey. SETTING: A UK-wide survey of experts. POPULATION: A panel of 20 members consisting of obstetricians, midwives and urogynecologists recommended by UK professional bodies. METHODS: A 58-item web-based questionnaire was sent to all participants who were asked to anonymously rate the importance of each item on a six-point Likert scale. They were asked to rate their level of agreement on statements related to hands-on/hands-poised techniques, the association of hands-poised/hands-off approach with OASIS, the need to implement perineal support and the need to improve the evidence to support it. Systematic feedback of responses from previous rounds was provided to participants. MAIN OUTCOME MEASURES: To achieve consensus on key areas related to perineal support. RESULTS: The response rate was 100% in all three iterations. There was consensus that current UK practice regarding perineal protection was not based on robust evidence. The respondents agreed that hands-poised/hands-off and OASIS are causally related and that hands-poised was misinterpreted by clinicians as hands-off. Although 90% of experts agreed that some form of randomized trial was required and that all would be prepared to take part, there was also consensus (75%) that in the meantime, hands-on should be the recommended technique. CONCLUSIONS: Our results highlight the current lack of evidence to support policies of perineal support at time of birth and the need to address this controversial issue.

Perinatal psychiatric disorders: an overview.

Perinatal mental illness has a significant implication on maternal health, birth outcomes, and the offspring's development. Prevalence estimates of perinatal psychiatric illnesses range widely, with substantial heterogeneity in different population studies, with a lower prevalence rate in high- rather than low- or middle-income countries. Because of the potential negative impact on maternal and child outcomes and the potential lability of these disorders, the perinatal period is a critical time to identify psychiatric illnesses. Thus, obstetricians and midwives play a crucial role in assessing women's mental health needs and to refer identified women promptly for multidisciplinary specialist assessment. However, there is still limited evidence on best practice assessment and management policies during pregnancy and postpartum. This review focuses on the prevalence of common perinatal mental disorders and antenatal screening policies to identify women at risk. The effect of these conditions and their management on pregnancy, fetal outcomes, and child development are discussed.

Coccygeal movement test: an objective, non-invasive test for localization of the pelvic floor muscles in healthy women.

OBJECTIVE: To evaluate the use of palpation of the coccyx (the coccygeal movement test, CMT) as a possible objective screening tool for the assessment of adequate localization of the pelvic floor muscles (PFMs). SUBJECTS AND METHODS: Twenty-four healthy female volunteers, known to be able to locate their PFMs, were given instructions (allocated at random) to perform a 'correct contraction', 'straining' or 'nothing' when examined by six independent assessors using the CMT. The assessors were blinded to the instructions and to the test results recorded by other assessors. Data were available for 137 observations, and these were dichotomized into either 'able to contract' ('correct contraction') or 'not able to contract' ('straining' or 'nothing'). This information was used to calculate the sensitivity, specificity and positive and negative predictive values for the CMT. RESULTS: The CMT correctly identified 56/58 observations when women did not perform the contraction of the PFMs compared to 61/79 observations when they did. Hence, the sensitivity and specificity were 97 and 77%, respectively. CONCLUSION: This study showed that the CMT was a useful test to identify women who were able to localize their PFMs compared to those who were not, making it a potentially useful initial screening test in structured training programmes for the PFMs.

Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial.

BACKGROUND: Perineal trauma during childbirth affects millions of women worldwide every year. The aim of the Perineal Assessment and Repair Longitudinal Study (PEARLS) was to improve maternal clinical outcomes following childbirth through an enhanced cascaded multiprofessional training program to support implementation of evidence-based perineal management. METHODS: This was a pragmatic matched-pair cluster randomized controlled trial (RCT) that enrolled women (n = 3681) sustaining a second-degree perineal tear in one of 22 UK maternity units (clusters), organized in 11 matched pairs. Units in each matched pair were randomized to receive the training intervention either early (group A) or late (group B). Outcomes within each cluster were assessed prior to any training intervention (phase 1), and then after the training intervention was given to group A (phase 2) and group B (phase 3). Focusing on phase 2, the primary outcome was the percentage of women who had pain on sitting or walking at 10 to 12 days post-natal. Secondary outcomes included use of pain relief at 10 to 12 days post-natal, need for suture removal, uptake and duration of exclusive breastfeeding, and perineal wound infection. Practice-based measures included implementation of evidence into practice to promote effective clinical management of perineal trauma. Cluster-level paired t-tests were used to compare groups A and B. RESULTS: There was no significant difference between the clusters in phase 2 of the study in the average percentage of women reporting perineal pain on sitting and walking at 10 to 12 days (mean difference 0.7%; 95% CI -10.1% to 11.4%; P = 0.89). The intervention significantly improved overall use of evidence-based practice in the clinical management of perineal trauma. Following the training intervention, group A clusters had a significant reduction in mean percentages of women reporting perineal wound infections and of women needing sutures removed. CONCLUSION: PEARLS is the first RCT to assess the effects of a 'training package on implementation of evidence-based perineal trauma management. The intervention did not significantly improve the primary outcome but did significantly improve evidence-based practice and some of the relevant secondary clinical outcomes for women. TRIAL REGISTRATIONS: ISRCTN28960026 NIHR UKCRN portfolio no: 4785.

Antiepileptic drugs and the fetal epigenome.

Antiepileptic drugs (AEDs) can lower maternal folate and increase maternal homocysteine levels, which are known to affect the methyl cycle and hence DNA methylation levels. The influence of in utero exposure to AEDs on fetal DNA methylation was investigated. Genome-wide fetal epigenomic profiles were determined using the Infinium 27K BeadArray from Illumina (San Diego, CA, U.S.A.). The Infinium array measures approximately 27,000 CpG loci associated with 14,496 genes at single-nucleotide resolution. Eighteen cord blood samples (nine samples from babies exposed to AEDs and nine controls) from otherwise uncomplicated pregnancies were compared. Unsupervised hierarchic clustering was used to compare the calculated methylation profiles. A clear distinction between the methylation profiles of samples from babies exposed to AEDs in utero compared with controls was detected. These data provide evidence of an epigenetic effect associated with antenatal AED and high-dose folate supplementation during pregnancy. The differences in fetal DNA methylation of those exposed to AEDs shows that a genome-wide effect of methylation is evident. In addition, the epigenetic changes observed appear to be, in this limited sample, independent of extremes of birth weight centiles. These preliminary data highlight possible mechanisms by which AEDs might influence fetal outcomes and the potential of optimizing AED-specific folate supplementation regimens to offset these effects.

Secondary suturing compared to non-suturing for broken down perineal wounds following childbirth.

BACKGROUND: Each year approximately 350,000 women in the United Kingdom and millions more worldwide, experience perineal suturing following childbirth. The postpartum management of perineal trauma is a core component of routine maternity care. However, for those women whose perineal wound dehisces (breaks down), the management varies depending on individual practitioners preferences as there is limited scientific evidence and no clear guidelines to inform best practice. For most women the wound will be managed expectantly whereas, others may be offered secondary suturing. OBJECTIVES: To evaluate the therapeutic effectiveness of secondary suturing of dehisced perineal wounds compared to non-suturing (healing by secondary intention, expectancy). SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 July 2013) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials of secondary suturing of dehisced perineal wounds (second-, third- or fourth-degree tear or episiotomy), following wound debridement and the removal of any remaining suture material within the first six weeks following childbirth compared with non-suturing. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion. Two review authors independently assessed trial quality and extracted data. Data were checked for accuracy. MAIN RESULTS: Two small studies of poor methodological quality including 52 women with a dehisced and/or infected episiotomy wound at point of entry have been included.Only one small study presented data in relation to wound healing at less than four weeks, (the primary outcome measure for this review), although no reference was made to demonstrate how healing was measured. There was a trend to favour this outcome in the resuturing group, however, this difference was not statistically significant (risk ratio (RR) 1.69, 95% confidence interval (CI) 0.73 to 3.88, one study, 17 women).Similarly, only one trial reported on rates of dyspareunia (a secondary outcome measure for this review) at two months and six months with no statistically significant difference between both groups; two months, (RR 0.44, 95% CI 0.18 to 1.11, one study, 26 women) and six months, (RR 0.39, 95% CI 0.04 to 3.87, one study 32 women). This trial also included data on the numbers of women who resumed sexual intercourse by two months and six months. Significantly more women in the secondary suturing group had resumed intercourse by two months (RR 1.78, 95% CI 1.10 to 2.89, one study, 35 women), although by six months there was no significant difference between the two groups (RR 1.08, 95% CI, 0.91 to 1.28).Neither of the trials included data in relation to the following prespecified secondary outcome measures: pain at any time interval; the woman's satisfaction with the aesthetic results of the perineal wound; exclusive breastfeeding; maternal anxiety or depression. AUTHORS' CONCLUSIONS: Based on this review, there is currently insufficient evidence available to either support or refute secondary suturing for the management of broken down perineal wounds following childbirth. There is an urgent need for a robust randomised controlled trial to evaluate fully the comparative effects of both treatment options.

Clinical subtypes of core premenstrual disorders: a Delphi survey.

The purpose of this study was to classify the clinical subtypes of core premenstrual disorders during the International Society for Premenstrual Disorders' second consensus meeting. Multiple iterations were used to achieve consensus between a group of experts; these iterations included a two-generational Delphi technique that was preceded and followed by open group discussions. The first round was to generate a list of all potential clinical subtypes, which were subsequently prioritized using a Delphi methodology and then finalised in a final round of open discussion. On a six-point scale, 4 of the 12 potential clinical subtypes had a mean score of ≥5.0 following the second iteration and only 3 of the 4 still had a mean score of ≥5.0 after the third iteration. The final list consisted of these three subtypes and an additional subtype, which was introduced and agreed upon, in the final iteration. There is consensus amongst experts that core premenstrual disorder is divided into three symptom-based subtypes: predominantly physical, predominantly psychological and mixed. A proportion of psychological and mixed subtypes may meet the DSM-IV diagnostic criteria for premenstrual dysphoric disorder.

The development and validation of an internet-based training package for the management of perineal trauma following childbirth: MaternityPEARLS.

BACKGROUND: Birth-related perineal trauma has a major impact on women's health. Appropriate management of perineal injuries requires clinical knowledge and skill. At present, there is no agreement as to what constitutes an effective clinical training programme, despite the presence of sufficient evidence to support standardised perineal repair techniques. To address this deficiency, we developed and validated an interactive distance learning multi-professional training package called MaternityPEARLS. METHOD: MaternityPEARLS was developed as a comprehensive e-learning package in 2010. The main aim of the MaternityPEARLS project was to develop, refine and validate this multi-professional e-learning tool. The effect of MaternityPEARLS in improving clinical skills and knowledge was compared with two other training models; traditional training (lectures + model-based hands on training) and offline computer lab-based training. Midwives and obstetricians were recruited for each training modality from three maternity units. An analysis of covariance was done to assess the effects of clinical profession and years of experience on scoring within each group. Feedback on MaternityPEARLS was also collected from participants. The project started in January 2010 and was completed in December 2010. RESULTS: Thirty-eight participants were included in the study. Pretraining and post-training scores in each group showed considerable improvement in skill scores (p<0.001 in all groups). Mean changes were similar across all three groups for knowledge (3.24 (SD 5.38), 3.00 (SD 3.74), 3.30 (SD 3.73)) and skill (25.34 (SD 8.96), 22.82 (SD 9.24), 20.7 (SD 9.76)) in the traditional, offline computer lab-based and e-learning groups, respectively. There was no evidence of any effect of clinical experience and baseline knowledge on outcomes. CONCLUSIONS: MaternityPEARLS is the first validated perineal trauma management e-learning package. It provides a level of improvement in skill and knowledge comparable to traditional methods of training. However, as an e-learning system, it has the advantage of ensuring the delivery of a standardised, continuously updated curriculum that has global accessibility.

Accuracy of liver function tests for predicting adverse maternal and fetal outcomes in women with preeclampsia: a systematic review.

BACKGROUND: Liver function tests are routinely performed in women as part of a battery of investigations to assess severity at admission and later to guide appropriate management. OBJECTIVE: To determine the accuracy with which liver function tests predict complications in women with preeclampsia by a systematic review. DATA: We conducted electronic searches without language restrictions in (1951-2010), (1980-2010) and the Cochrane Library (2009). METHODS OF STUDY SELECTION: Primary articles that evaluated the accuracy of liver function tests in predicting complications in women with preeclampsia were chosen. Data was extracted by two reviewers independently. A bivariate model estimated area under the curve, sensitivity and specificity. RESULTS: There were 13 primary articles including a total of 3 497 women assessing maternal (30 2×2 tables) and fetal (19 2×2 tables) outcomes. For predicting adverse maternal outcome, the point estimates of specificity were >70% in 18 tables with 0.79 (95%CI 0.51, 0.93). For predicting adverse fetal outcomes the specificity of the test was >70% in 2×2 tables. Sensitivity of the test was poor for both maternal and fetal outcomes. CONCLUSION: In women with preeclampsia, function tests performed better in predicting adverse maternal than fetal outcomes. The presence of increased liver enzymes was associated with an increased probability of maternal and fetal complications, but normal liver enzyme levels did not rule out disease, as specificity was often higher than sensitivity.

How accurate are maternal symptoms in predicting impending complications in women with preeclampsia? A systematic review and meta-analysis.

BACKGROUND: Maternal symptoms such as severe headache, nausea and vomiting, visual disturbances and epigastric pain have been associated with complications in women with preeclampsia. OBJECTIVE: To determine the accuracy of maternal symptoms in predicting complications in women with preeclampsia by systematic review. DATA SOURCES: We searched MEDLINE (1951-2010), EMBASE (1980-2010), the Cochrane Library (2009) and the MEDION database. METHODS OF STUDY SELECTION: Studies which evaluated the accuracy of symptoms in women with preeclampsia for predicting complications were selected in a two-stage process. Information was extracted by two independent reviewers. We summarized accuracy with a bivariate model estimating sensitivity, specificity and area under the curve. RESULTS: Six primary articles with 2573 women were included. The area under the curve for predicting complications for headache, epigastric pain and visual disturbances was 0.58 (95%CI 0.24-0.86), 0.70 (95%CI 0.30-0.93) and 0.74 (95%CI 0.33-0.94). The sensitivity and specificity of the symptoms in predicting adverse maternal outcomes were respectively as follows: headache 0.54 (95%CI 0.27-0.79) and 0.59 (95%CI 0.38-0.76); epigastric pain 0.34 (95%CI 0.22-0.5) and 0.83 (95%CI 0.76-0.89); visual disturbances 0.27 (95%CI 0.07-0.65) and 0.81 (95%CI 0.71, 0.88); nausea and vomiting 0.24 (95%CI 0.21, 0.27) and 0.87 (95%CI 0.85, 0.89). CONCLUSION: The presence of symptoms is more useful in predicting complications in preeclampsia compared to their absence in excluding adverse events.

Towards a consensus on diagnostic criteria, measurement and trial design of the premenstrual disorders: the ISPMD Montreal consensus.

Premenstrual disorders (PMD) are characterised by a cluster of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle and resolve during menses (Freeman and Sondheimer, Prim Care Companion J Clin Psychiatry 5:30-39, 2003; Halbreich, Gynecol Endocrinol 19:320-334, 2004). Although PMD have been widely recognised for many decades, their precise cause is still unknown and there are no definitive, universally accepted diagnostic criteria. To consider this issue, an international multidisciplinary group of experts met at a face-to-face consensus meeting to review current definitions and diagnostic criteria for PMD. This was followed by extensive correspondence. The consensus group formally became established as the International Society for Premenstrual Disorders (ISPMD). The inaugural meeting of the ISPMD was held in Montreal in September 2008. The primary aim was to provide a unified approach for the diagnostic criteria of PMD, their quantification and guidelines on clinical trial design. This report summarises their recommendations. It is hoped that the criteria proposed here will inform discussions of the next edition of the World Health Organisation's International Classification of Diseases (ICD-11), and the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) criteria that are currently under consideration. It is also hoped that the proposed definitions and guidelines could be used by all clinicians and investigators to provide a consistent approach to the diagnosis and treatment of PMD and to aid scientific and clinical research in this field.

Analysis of the serotonin transporter promoter rs25531 polymorphism in premenstrual dysphoric disorder.

OBJECTIVE: The objective of this study was to investigate whether the functional rs25531 promoter polymorphism in the serotonin transporter gene is associated with premenstrual dysphoric disorder. STUDY DESIGN: The study sample comprised 53 women with clinically diagnosed premenstrual dysphoric disorder (age range, 27-46 years; mean, 37.7 years) and 52 healthy control subjects (age range, 22-48 years; mean, 36.2 years). The rs25531 polymorphism was genotyped in both groups. Because of its close proximity to rs25531, the 5-HTTLPR promoter polymorphism was also genotyped. Genotype and allele frequencies for rs25531 and for the composite 5-HTTLPR/rs25531 marker were analyzed by chi(2) test. RESULTS: There was no significant association between any genotype and clinical category and no significant allele distribution profiles for rs25531 or 5-HTTLPR/rs25531 in either the premenstrual dysphoric disorder or the control groups. CONCLUSION: These findings do not support a major role for rs25531, either in isolation or combined with 5-HTTLPR, in contributing to susceptibility to premenstrual dysphoria.

PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial.

BACKGROUND: The Perineal Assessment and Repair Longitudinal Study (PEARLS) is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women. METHODS/DESIGN: PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere) and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh Postnatal Depression Scale (EPDS) will be assessed at 10 days and three months post-birth. DISCUSSION: Implementation of evidence-based perineal assessment and management practices, could lead to significantly improved physical and psychological health outcomes for women in the UK and world-wide. TRIAL REGISTRATION: PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.

Triply troubled: criminal behaviour and mental health in a cohort of teenage pregnant substance misusers in treatment.

BACKGROUND: Teenage substance misuse and pregnancy are major public health problems in the UK, where the most recent figures on maternal deaths suggest that they have doubled among young substance misusers. In general, little is known about their pregnancy outcomes. AIMS: The aims of this study were to describe the characteristics of a sample of teenage pregnant drug users in the UK, to examine their psychosocial risk and complicating factors at presentation, to evaluate adherence to current national guidelines and to assess the adequacy of guidelines in relation to identified characteristics. METHODS: A six-year records survey of young people attending a specialist adolescent drug misuse service in the west midlands of the UK. RESULTS: Ten pregnant adolescents were identified from records. These girls have had unstable or abusive experiences through childhood, half having other substance misusers in the family. All were with substantially older partners, who were also substance misusers. All had required a mental health assessment and 90% had a history of self-harm. There were no maternal or neonatal deaths, and only one girl had a miscarriage, but in four cases, the child had to be fostered. CONCLUSIONS: To our knowledge, this is the first analysis of this kind in the UK. Available guidelines were followed, but our findings suggest that more detailed and comprehensive guidelines are required. Preventive measures through education are likely to be hampered by the early age at which these girls cease attending school.

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.