Fetal loss following second trimester amniocentesis. Who is at greater risk? How to counsel pregnant women?

Objective: The purpose of this retrospective observational cohort study was to determine the impact of certain risk factors on fetal loss, after mid-trimester amniocentesis.

Material and methods: Six thousand seven-hundred and fifty-two (6752) consecutive amniocenteses with known pregnancy outcome performed during a 7-year period (2004–2010) were included in this study. Different maternal-, fetal- and procedure-related factors were evaluated in this study.

Results: During this 7-year period, 6752 cases who underwent amniocentesis, with complete data available were evaluated for the outcome and risk factors mentioned. Total fetal loss rate (FLR) up to the 24th week was 1.19%. Risk factors associated with increased risk of fetal loss after amniocentesis were maternal age (OR:2.0), vaginal spotting (OR:2.2) and serious bleeding (OR:3.5) during pregnancy, history of 2nd trimester termination of pregnancy (OR:4.0), history of more than three spontaneous (OR:3.0) or surgical first trimester abortions (OR:2.1), fibromas (OR:3.0) and stained amniotic fluid (OR:6.1).

Conclusions: Amniocentesis is a safe-invasive procedure for prenatal diagnosis with total FLR of 1.19% in our institution during the study period. The present study has emphasized the significance of certain risk factors for adverse outcome and therefore the need to individualize the risk.     

The diagnostic effectiveness of an initial transvaginal scan in detecting ectopic pregnancy

BACKGROUND: To determine the effectiveness of an initial transvaginal ultrasound scan (TVS) in the detection of ectopic pregnancy in consecutive women attending an early pregnancy unit (EPU). METHODS: This was a prospective observational study. Unselected women attending a dedicated EPU underwent a TVS. Women were classified as having an intrauterine pregnancy (IUP), ectopic pregnancy or pregnancy of unknown location (PUL). Women with a PUL were followed up until the final location of the pregnancy was determined. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals (CIs) for the initial TVS in the diagnosis of ectopic pregnancy were calculated. RESULTS: During a one-year study period, 5318 consecutive women attended the EPU. Outcome data were available for 5240 (98.5%) women. Of these, the initial TVS showed an IUP in 4693 (89.6%) cases and an ectopic pregnancy in 91 (1.7%) cases. The remaining 456 (8.7%) women were classified as PUL, and of these 31 (6.8%) were subsequently found to have ectopic pregnancies. The overall sensitivity of the initial TVS in the diagnosis of ectopic pregnancy was 73.9% (95% CI: 65.1-81.6) with a specificity of 99.9% (95% CI: 99.8-100), a PPV of 96.7% (95% CI: 90.7-99.3) and an NPV of 99.4% (95% CI: 99.2-99.6). CONCLUSIONS: In unselected women attending an EPU, pregnancy location can be diagnosed accurately in over 90% of all pregnancies and in 73.9% of ectopic pregnancies with a single TVS.     

Achieving high uptake of human papillomavirus vaccination in Malaysia through school-based vaccination programme

Background

In 2006, 4 years of planning was started by the Ministry of Health, Malaysia (MOH), to implement the HPV (human papillomavirus) vaccination programme. An inter-agency and multi-sectoral collaborations were developed for Malaysia’s HPV school-based immunisation programme. It was approved for nationwide school base implementation for 13-year-old girls or first year secondary students in 2010. This paper examines how the various strategies used in the implementation over the last 7?years (2010–2016) that unique to Malaysia were successful in achieving optimal coverage of the target population.

Methods

Free vaccination was offered to school girls in secondary school (year seven) in Malaysia, which is usually at the age of 13 in the index year. All recipients of the HPV vaccine were identified through school enrolments obtained from education departments from each district in Malaysia. A total of 242,638 girls aged between 12 to 13?years studying in year seven were approached during the launch of the program in 2010. Approximately 230,000 girls in secondary schools were offered HPV vaccine per year by 646 school health teams throughout the country from 2010 to 2016.

Results

Parental consent for their daughters to receive HPV vaccination at school was very high at 96–98% per year of the programme. Of those who provided consent, over 99% received the first dose each year and 98–99% completed the course per year. Estimated population coverage for the full vaccine course, considering also those not in school, is estimated at 83 to 91% per year. Rates of adverse events reports following HPV vaccination were low at around 2 per 100,000 and the majority was injection site reactions.

Conclusion

A multisectoral and integrated collaborative structure and process ensured that the Malaysia school-based HPV immunisation programme was successful and sustained through the programme design, planning, implementation and monitoring and evaluation. This is a critical factor contributing to the success and sustainability of the school-based HPV immunisation programme with very high coverage.

     

An introduction to the My Body is Fit and Fabulous at home (MyBFF@home): a community-based weight loss intervention study among Malaysian housewives

Background

The national prevalence of overweight and obesity in Malaysia has been increasing in the past 10 years and many efforts have been implemented by the Malaysian government to combat obesity problem among the Malaysian population. The aim of this paper was to describe the background of the My Body is Fit and Fabulous at home (MyBFF@home) study (Phase II).

Discussion

The MyBFF@home (Phase II) was a quasi-experimental study and it was conducted among overweight and obese housewives living in the urban areas in Malaysia. In this phase, the study involved a weight loss intervention phase (6 months) and a weight loss maintenance phase (6 months). The intervention group received a standard weight loss intervention package and the control group received group seminars related to women’s health. Measurements of weight, height, waist circumference, body composition, fasting blood lipids, dietary intake, physical activity, health literacy, body pain and quality of life were conducted during the study. Overweight and obese housewives from 14 People’s Housing/Home Project (PHP) in Federal Territory of Kuala Lumpur (Klang Valley) were selected as control and intervention group (N?=?328). Majority of the participants (76.1%) were from the low socioeconomic group. Data were analysed and presented according to the specific objectives and the needs for the particular topic in the present supplement report.

Conclusion

MyBFF@home is the first and the largest community-based weight loss intervention study which was conducted among overweight and obese housewives in Malaysia. Findings of the study could be used by the policy makers and the researchers to enhance the obesity intervention programme among female adults in Malaysia.

     

Comparison between self-reported physical activity (IPAQ-SF) and pedometer among overweight and obese women in the MyBFF@home study

Background

Several methods have been developed to determine a person’s physical activity level. However, there is limited evidence in determining whether someone is physically active or not. This study aims to determine the level of physical activity and to compare the usage of short version International Physical Activity Questionnaire (IPAQ-SF) and pedometer among overweight and obese women who were involved in the My Body is Fit and Fabulous at home (MyBFF@home) study.

Methods

Baseline and sixth month data from the MyBFF@home study were used for this purpose. A total of 169 of overweight and obese respondents answered the IPAQ-SF and were asked to use a pedometer for 7 days. Data from IPAQ-SF were categorised as inactive and active while data from pedometer were categorised as insufficiently active and sufficiently active by standard classification. Data on sociodemographic and anthropometry were also obtained. Cohen’s kappa was applied to measure the agreement of IPAQ-SF and pedometer in determining the physical activity level. Pre-post cross tabulation table was created to evaluate the changes in physical activity over 6 months.

Results

From 169 available respondents, 167 (98.8%) completed the IPAQ-SF and 107 (63.3%) utilised the pedometer. A total of 102 (61.1%) respondents were categorised as active from the IPAQ-SF. Meanwhile, only 9 (8.4%) respondents were categorised as sufficiently active via pedometer. Cohen’s κ found there was a poor agreement between the two methods, κ?=?0.055, p?>?0.05. After sixth months, there was +?9.4% increment in respondents who were active when assessed by IPAQ-SF but ??1.3% reductions for respondents being sufficiently active when assessed by pedometer. McNemar’s test determined that there was no significant difference in the proportion of inactive and active respondents by IPAQ-SF or sufficiently active and insufficiently active by pedometer from the baseline and sixth month of intervention.

Conclusion

The IPAQ-SF and pedometer were both able to measure physical activity. However, poor agreement between these two methods were observed among overweight and obese women.

     

Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries

Background

Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value.

Objective

To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment.

Methods

A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) ‘Responsibilities and structure of HTA agencies’; (2) ‘Evidence and evaluation criteria considered in HTAs’; (3) ‘Methods and techniques applied in HTAs’; and (4) ‘Outcomes and implementation of HTAs’. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts.

Results

All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional ‘social value judgements’ (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making.

Conclusion

More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness.

     

Concurrent pleural infiltration by chronic lymphocytic leukemia and adenocarcinoma of unknown primary site diagnosed by effusion cytology

Synchronous malignancies in a pleural effusion are rare. A case of concurrent pleural infiltration by adenocarcinoma of unknown primary site and chronic lymphocytic leukemia (CLL) is presented in this case study, which was diagnosed by effusion cytology. Pleural effusion is not an uncommon complication in patients with B‐CLL. Even in a pleural effusion rich in monoclonal lymphocytes, the presence of a second cancer must be excluded because this can be the main cause of mortality. The role of cytology in such cases is of paramount importance. Diagn. Cytopathol. 2014;42:151–155. © 2012 Wiley Periodicals, Inc.     

Takayasu arteritis in pregnancy: safe management options in antenatal care. Case report

Takayasu arteritis is a nonspecific chronic inflammatory vascular disease of unknown etiology with a higher incidence during the child-bearing years. It usually involves the branches of the aortic arch. Most of the patients enter the pregnancy being already diagnosed as having the disease and being on medication. The state of the disease in early pregnancy is a definitive factor for determining its management. Although it seems that pregnancy is a state favorable to this disease, nevertheless, complications should be anticipated, and close multidisciplinary maternal and fetal surveillance is mandatory. Early-onset hypertension is the commonest complication, and its magnitude during the late gestational period is the second definitive factor for the management of these pregnancies. A vaginal delivery should be aimed at term with continuous electronic fetal monitoring. The immediate postpartum period is usually uncomplicated despite the circulatory alterations that take place.     

Uterine artery Doppler in the prediction of adverse pregnancy outcome

PURPOSE OF REVIEW: To review publications, published during the past year, that have examined uterine artery Doppler findings in women with adverse pregnancy outcome. RECENT FINDINGS: Almost two-thirds of stillbirths that occur in the early preterm period (up to 32 weeks) can be predicted by uterine artery Doppler at 23 weeks. First trimester screening studies have shown that an abnormal result increases the risk of subsequent fetal growth restriction, and such women are at particularly high risk when indices remain abnormal in the second trimester. Studies combining uterine artery Doppler with maternal serum markers have demonstrated that measurement of first-trimester maternal serum pregnancy-associated plasma protein A and free beta human chorionic gonadotrophin improve sensitivities of second-trimester Doppler. As these are frequently measured in Down syndrome screening and they lend themselves in screening for pre-eclampsia. Women with abnormal first and second-trimester serum markers constitute a high-risk group. Maternal serum placental protein 13 remains a promising method for early screening, although a recent study suggests lower sensitivities than initially reported. SUMMARY: Uterine artery Doppler screening identifies women at high risk for developing adverse pregnancy outcomes. Detection rates may be increased and false positive rates reduced by combination with maternal characteristics or serum markers.     

Maternal uterine artery Doppler flow velocimetry and the risk of stillbirth

OBJECTIVE: We sought to relate the risk of antepartum stillbirth to uterine artery Doppler flow velocimetry at 22-24 weeks. METHODS: Data were available from 30,519 unselected women from seven units in the UK who had uterine artery Doppler performed between 22 and 24 weeks of gestation. The risk of stillbirth (n=109) was assessed using time to event and logistic regression analysis. Stillbirths were subdivided into placental (due to abruption, preeclampsia, or growth restriction) or unexplained. RESULTS: The risk of placental stillbirth was increased among women with a mean pulsatility index in the top decile (adjusted hazard ratio [HR] 5.5, 95% confidence interval [CI] 2.8-10.6) and those with a bilateral notch (adjusted HR 3.9, 95% CI 2.0-7.8). The relationship between a mean pulsatility index in the top decile and the risk of unexplained stillbirth was weaker (adjusted HR 2.5, 95% CI 1.1-5.6) and there was no association with a bilateral notch. Placental stillbirths occurred at earlier gestations than unexplained stillbirths (median [interquartile range] 30 [26-36] compared with 38 [36-40], P<.001). Consequently, being in the top 5% of predicted risk of stillbirth on the basis of the combination of mean pulsatility index and notching was a good predictor (sensitivity, specificity, and positive likelihood ratio) of all cause stillbirth up to 32 weeks (58%, 95%, and 12.1, respectively) but a poor predictor of stillbirth at later gestations (7%, 95%, and 1.3, respectively). CONCLUSION: Abnormal uterine artery Doppler was a better predictor of the risk of stillbirth due to placental causes than unexplained stillbirth. Consequently, abnormal uterine artery Doppler was a good predictor of stillbirth at extreme preterm gestations but a poor predictor of stillbirth at term. LEVEL OF EVIDENCE: II.