Author Interviews, Biomarkers, NEJM, OBGYNE / 06.01.2016
Elecsys® immunoassay Helps Predict Preeclampsia in Suspected Pregnancies
MedicalResearch.com Interview with:
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Dr. Stefan Verlohren[/caption]
Stefan Verlohren, MD, PhD
Consultant and Senior Lecturer
Maternal-Fetal Medicine
Klinik für Geburtsmedizin / Department of Obstetrics
Charité Campus Mitte
Berlin
Medical Research: What is the background for this study? What are the main findings?
Dr. Verlohren: Preeclampsia affects 2–5% of pregnancies worldwide, and is a potentially life threatening syndrome for both mother and child. Treatment options for preeclampsia are very limited, with delivery being the only ‘cure’; however, early detection and monitoring are beneficial for improving maternal and fetal outcomes. Development of preeclampsia is very difficult to predict: its clinical presentation is variable and its signs and symptoms overlap with other conditions. There has been an unmet medical need for improved prediction of preeclampsia, i.e. predicting which women will develop preeclampsia and which will not. Women with suspected preeclampsia are often hospitalized until preeclampsia and related adverse outcomes are ruled out. Others who require hospitalization may be overlooked because their symptoms were nonspecific (e.g. headache).
Preeclampsia has been linked with impaired function of the placenta. Placental development is highly dependent on blood vessel formation; before and during preeclampsia, levels of molecules involved in blood vessel inhibition or growth are altered in the maternal bloodstream. In particular, soluble fms-like tyrosine kinase-1 (sFlt-1) (a molecule that inhibits blood vessel growth) is increased and placental growth factor (PlGF) (a molecule that encourages blood vessel growth) is decreased. This study has established that the ratio of these two molecules (sFlt-1:PlGF) can be used to predict whether preeclampsia will develop or not.
The sFlt-1:PlGF ratio can be calculated with a blood test (the Elecsys® sFlt-1 immunoassay and Elecsys® PlGF immunoassay). PROGNOSIS has validated the sFlt-1:PlGF ratio cutoff level of 38 for prediction of preeclampsia. For women with suspected preeclampsia, the Elecsys® immunoassay sFlt-1:PlGF ratio of 38 or below has a high negative predictive value to rule out preeclampsia or adverse fetal outcomes in the next week. A Elecsys® immunoassay sFlt-1:PlGF ratio of more than 38 indicates that preeclampsia or fetal adverse outcomes may develop in the next four weeks. In conjunction with other diagnostic and clinical information, the Elecsys® immunoassay sFlt-1:PlGF ratio can be used to guide patient management.
Dr. Stefan Verlohren[/caption]
Stefan Verlohren, MD, PhD
Consultant and Senior Lecturer
Maternal-Fetal Medicine
Klinik für Geburtsmedizin / Department of Obstetrics
Charité Campus Mitte
Berlin
Medical Research: What is the background for this study? What are the main findings?
Dr. Verlohren: Preeclampsia affects 2–5% of pregnancies worldwide, and is a potentially life threatening syndrome for both mother and child. Treatment options for preeclampsia are very limited, with delivery being the only ‘cure’; however, early detection and monitoring are beneficial for improving maternal and fetal outcomes. Development of preeclampsia is very difficult to predict: its clinical presentation is variable and its signs and symptoms overlap with other conditions. There has been an unmet medical need for improved prediction of preeclampsia, i.e. predicting which women will develop preeclampsia and which will not. Women with suspected preeclampsia are often hospitalized until preeclampsia and related adverse outcomes are ruled out. Others who require hospitalization may be overlooked because their symptoms were nonspecific (e.g. headache).
Preeclampsia has been linked with impaired function of the placenta. Placental development is highly dependent on blood vessel formation; before and during preeclampsia, levels of molecules involved in blood vessel inhibition or growth are altered in the maternal bloodstream. In particular, soluble fms-like tyrosine kinase-1 (sFlt-1) (a molecule that inhibits blood vessel growth) is increased and placental growth factor (PlGF) (a molecule that encourages blood vessel growth) is decreased. This study has established that the ratio of these two molecules (sFlt-1:PlGF) can be used to predict whether preeclampsia will develop or not.
The sFlt-1:PlGF ratio can be calculated with a blood test (the Elecsys® sFlt-1 immunoassay and Elecsys® PlGF immunoassay). PROGNOSIS has validated the sFlt-1:PlGF ratio cutoff level of 38 for prediction of preeclampsia. For women with suspected preeclampsia, the Elecsys® immunoassay sFlt-1:PlGF ratio of 38 or below has a high negative predictive value to rule out preeclampsia or adverse fetal outcomes in the next week. A Elecsys® immunoassay sFlt-1:PlGF ratio of more than 38 indicates that preeclampsia or fetal adverse outcomes may develop in the next four weeks. In conjunction with other diagnostic and clinical information, the Elecsys® immunoassay sFlt-1:PlGF ratio can be used to guide patient management.
Dr. Halwani[/caption]
MedicalResearch.com Interview with:
Muhammad A. Halwani, MSc, PhD
Faculty of Medicine, Al Baha University
Al Baha, Saudi Arabia.
Medical Research: What is the background for this study? What are the main findings?
Response: The study idea was based on examining the current rate of post cesarean section infections that were detected in the hospital at the time. It was hypothesized that the detected infections were actually less than the real number identified. Therefore, we challenged the traditional surveillance method that was applied in the hospital with a new enhanced methodology which is telephone follow-ups for patients who under go C-section operations.
Our main finding proved that this new applied method was able to detect more cases than the traditional one. Using phone calls as a gold standard, the sensitivity of the standard methodology to capture SSI after cesarean increased to 73.3% with the new methodology identifying an extra five cases. These patients represented 26.3% (5 of 19) of all the patients who developed SSI. In other words, for every 100 C-section procedures there were 2.6% missed cases which the new method was able to detect. The duration of the calls ranged from 1 to 5 minutes and were well received by the patients.
Dr. Mairead Black[/caption]
MedicalResearch.com Interview with:
Dr Mairead Black MBChB, MRCOG, MSc
Research Fellow, Wellcome Trust
Clinical Lecturer, Obstetrics and Gynaecology
School of Medicine and Dentistry, Division of Applied Health Sciences
University of Aberdeen
Aberdeen Maternity Hospital, Cornhill Road
Aberdeen AB25 2ZD
Medical Research: What is the background for this study?
Dr. Black: The current thinking is, if a baby is exposed to labour, then it is also exposed to ‘good bacteria’ that mothers pass on during the birth, and they are also exposed to a degree of natural stress at the time of birth that might make them more resistant to developing future illnesses.
The World Health Organisation formerly recommended that no more than 15 percent of deliveries should be C-sections. However rates in some countries have soared – China and Brazil have rates in excess of 50%, whilst in the UK the figure is 26% with almost half of these being planned in advance.
The main purpose of this study was to explore whether health outcomes in children up to very early adulthood differ according to how they are delivered and whether avoiding labour entirely, i.e. via a planned C-section, could put children at a disadvantage compared to those delivered vaginally or by emergency C-section, where most will have been exposed to labour. The study analysed data from over 300,000 births between 1993 and 2007 across Scotland, using routinely collected data from seven linked databases.
Dr. Dagher[/caption]
Medical research.com Interview with:
Rada K. Dagher, Ph.D.
Assistant Professor
University of Maryland School of Public Health
Department of Health Services Administration
College Park, MD 20742
MedicalResearch: What is the background for this study?
Dr. Dagher: In the United States, 51% of all pregnancies are unintended, and these happen disproportionately among racial and ethnic minorities. For example, in 2008, rates of unintended pregnancies were 69% among African American women, 56% among Hispanic women, and 40% among White women. Our study utilized 2006-2010 data from a nationally representative dataset, the National Survey of Family Growth, to investigate the reasons behind these racial/ethnic disparities.
MedicalResearch: What are the main findings of this study?
Dr. Dagher: The main findings of this study are as follows. Age and marital status differences explained both racial and ethnic disparities, where being single and younger than 20 years old at the time of conception contributed to the differences in unintended pregnancy between African American and White women, and between Hispanic and White women. However, there were also unique factors explaining the differences in unintended pregnancy between African Americans and Whites (respondent’s mother’s age at first birth, income, and insurance status) and the differences between Hispanics and Whites (U.S. born status and educational level). These findings provide support for culturally-tailored public health interventions that target at-risk groups of women such as younger, unmarried, lower income, lower educated, non-U.S. born women and those with public insurance, in order to reduce racial/ethnic disparities in unintended pregnancy.
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Dagher: Our findings suggest that interventions to reduce racial and ethnic differences in 
Prof. Gordon Smith[/caption]
MedicalResearch.com Interview with:
Gordon C S Smith, MD PhD DSc FMedSci
Professor & Head of Department,
Obstetrics and Gynaecology,
Cambridge University
Cambridge UK
Medical Research: What were the key findings of the study?
Dr. Smith: We demonstrated that using ultrasound to scan all women in the last 3 months of pregnancy increased the detection of small babies. Our routine approach to antenatal care identified 1 in 5 small babies. Our research approach on the same patients, where all women were scanned in the last third of pregnancy, resulted in 3 in 5 small babies being detected.
We also found that, when we identified small babies, there was a scan measurement which helped us to distinguish which of those small babies were at increased risk of complications.
Medical Research: What's the problem with small babies?
Dr. Smith: We have known for many years that small babies are at increased risk of subsequent complications, both in the short term and long term. For example, they are more likely than normal sized babies to have difficulties during labour due to shortage of oxygen.
We assume that this is because their growth has been restricted. This leads to them being less well prepared to face the stress of labour. We think that the poor growth usually occurs because of a problem in the way the placenta functions. The placenta, also known as the afterbirth, is the organ which allows the transfer of nutrients and oxygen to the baby. If the placenta isn’t functioning properly it is likely to impair the growth of the baby in the womb.
If we suspect during a pregnancy that the baby is small, it influences a number of aspects of the care of the mother. For example, we might deliver the baby earlier, we might recommend delivery in a high risk unit. It might also influence decisions about whether a mother has a caesarean delivery, or how the baby is monitored during labour.
Dr. Thompson[/caption]
MedicalResearch.com Interview with:
Professor Benjamin Thompson PhD
School of Optometry and Vision Science
Faculty of Science, University of Waterloo
Waterloo, Ontario
Canada
Medical Research: What is the background for this study?
Dr. Thompson: Our investigation was part of the longitudinal Infant Development and Environment and Lifestyle (IDEAL) study that was designed to investigate the effect of prenatal methamphetamine exposure on neurodevelopment. Although the negative impact of prenatal drug exposure on a wide range of neurodevelopmental outcomes such cognitive and motor function is established, the effect on vision is not well understood. To address this issue, vision testing was conducted when children in the New Zealand arm of the IDEAL study turned four and half years of age.
Although the primary focus of the IDEAL study was the impact of methamphetamine on neurodevelopment, the majority of children enrolled in the study were exposed to a range of different drugs prenatally including marijuana, nicotine and alcohol. Many children were exposed to multiple drugs. This allowed us to investigate the impact of individual drugs and their combination on the children’s visual development.
Alongside standard clinical vision tests such as visual acuity (the ‘sharpness’ of vision) and stereopsis (3D vision), we also tested the children’s ability to process complex moving patterns. This test, known as global motion perception, targets a specific network of higher-level visual areas in the brain that are thought to be particularly vulnerable to neurodevelopmental risk factors.
Prof. Coomarasamy[/caption]
MedicalResearch.com Interview with:
Arri Coomarasamy, MBChB, MD, FRCOG
Professor of Gynaecology and Reproductive Medicine
University of Birmingham
Medical Research: What is the background for this study? What are the main findings?
Professor Coomarasamy: Progesterone is a natural hormone that is essential to maintain a healthy pregnancy, and more than 60 years ago clinicians and researchers began to ask if progesterone supplementation in the first trimester of pregnancy could help to reduce the risk of miscarriage for women with a history of recurrent miscarriage. The evidence achieved in some small controlled clinical trials conducted before the PROMISE (progesterone in recurrent miscarriage) trial suggested a benefit from progesterone therapy, but without sufficient certainty to usefully guide clinical practice.
Five years after it began, the PROMISE trial has provided a definitive result. It is clear, it is important, and it is not the result that many anticipated. Our study of more than 800 women with a history of unexplained recurrent miscarriage has shown that those who received progesterone treatment in early pregnancy were no less likely to miscarry than those who received a placebo (or dummy treatment). This was true whatever their age, ethnicity, and medical history.
Dr. Palmer[/caption]
MedicalResearch.com Interview with:
Dr William L Palmer
