Does Chemotherapy for Gynecological Malignancies during Pregnancy Cause Fetal Growth Restriction?

Cancer and pregnancy rarely coincide. Gynecological cancers are among the most common malignancies to occur during pregnancy, and chemotherapy with or without surgery is the primary treatment option. The main concern of administering chemotherapy during pregnancy is congenital malformation, although it can be avoided by delaying treatment until after organogenesis. The dose, frequency, choice of chemotherapeutic agents, time of treatment commencement, and method of administration can be adjusted to obtain the best maternal treatment outcomes while simultaneously minimizing fetal toxicity. Use of chemotherapy after the first trimester, while seemingly safe, can cause fetal growth restriction. However, the exact effect of chemotherapy on such fetal growth restriction has not been fully established; information is scarce owing to the rarity of malignancy occurring during pregnancy, the lack of uniform treatment protocols, different terminologies for defining certain fetal growth abnormalities, the influence of mothers’ preferred options, and ethical issues. Herein, we present up-to-date findings from the literature regarding the impact of chemotherapy on fetal growth.</jats:p

Clinical utility of a glycosylated fibronectin test (Lumella^TM) for assessment of impending preeclampsia

OBJECTIVE: Preeclampsia is a major pregnancy complication that results in significant maternal and infant mortality and morbidity, yet difficulties remain in the diagnosis of preeclampsia based on clinical parameters alone. The objective was to assess the performance of a hand-held point-of-care (POC) immunoassay in a clinical environment for glycosylated fibronectin (GlyFn) for the prediction of preeclampsia within 4 weeks of sampling. METHODS: Multinational European prospective observational pilot study of predominantly high-risk patients in the second half of pregnancy to assess a point-of-care immunoassay for GlyFn in predicting preeclampsia within 4 weeks of sampling. GlyFn was measured using a second generation hand held POC immunoassay. Results were considered normal for GlyFn concentrations of &lt; 350 µg/mL, positive for GlyFn concentrations of 351-600 µg/mL, and high-positive for GlyFn concentrations &gt; 600 µg/mL. RESULTS: Preeclampsia developed in 16 (19%) of 84 subjects and was associated with a shorter gestational age at delivery 35.3 weeks vs. 37.3 weeks for non-preeclamptics, n = 82; p = 0.001), a higher risk of fetal growth restriction (FGR; 31.2% vs. 10.3% for non-preeclamptics, p = 0.046), and an increased risk of preterm birth &lt; 37 weeks gestation (83.3% vs. 33.3% for non-preeclamptics, (n = 78; p = 0.003). GlyFn positive or high positive was seen in 13/16 (81%) and in 35/68 (51.5%), yielding a sensitivity of 81%, a specificity of 49%, a positive predictive value of 27%, and a negative predictive value of 92%. GlyFn positive or high positive was also associated with preterm birth &lt; 37 weeks in singleton pregnancy non-preeclamptic patients. Preterm birth occurred in 4.8% of those with normal GlyFn, in 26.7% with positive GlyFn, and in 50% of those with high GlyFn in singleton gestations without preeclampsia (p = 0.008). CONCLUSION: The ability to use this test in a POC format provides a method for practitioners to quickly determine risk for preeclampsia in their pregnant patients and offers an affordable alternative, as a single analyte to other diagnostic or screening tests that require laboratory-based testing or ultrasound equipment. Independent of preeclampsia, an elevated GlyFn was also correlated with preterm delivery and requires further study.</p

Dressings for the prevention of surgical site infection (Review)

Background Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured, often with sutures, staples, or clips. Wound dressings applied after wound closure may provide physical support, protection and absorb exudate. There are many different types of wound dressings available and wounds can also be left uncovered (exposed). Surgical site infection (SSI) is a common complication of wounds and this may be associated with using (or not using) dressings, or different types of dressing. Objectives To assess the effects of wound dressings compared with no wound dressings, and the effects of alternative wound dressings, in preventing SSIs in surgical wounds healing by primary intention. Search methods We searched the following databases: the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process &amp; Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print; 1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); EBSCO CINAHL Plus (1937 to 19 September 2016). There were no restrictions based on language, date of publication or study setting. Selection criteria Randomised controlled trials (RCTs) comparing wound dressings with wound exposure (no dressing) or alternative wound dressings for the postoperative management of surgical wounds healing by primary intention. Data collection and analysis Two review authors performed study selection, 'Risk of bias' assessment and data extraction independently. Main results We included 29 trials (5718 participants). All studies except one were at an unclear or high risk of bias. Studies were small, reported low numbers of SSI events and were often not clearly reported. There were 16 trials that included people with wounds resulting from surgical procedures with a 'clean' classification, five trials that included people undergoing what was considered 'clean/contaminated' surgery, with the remaining studies including people undergoing a variety of surgical procedures with different contamination classifications. Four trials compared wound dressings with no wound dressing (wound exposure); the remaining 25 studies compared alternative dressing types, with the majority comparing a basic wound contact dressing with film dressings, silver dressings or hydrocolloid dressings. The review contains 11 comparisons in total. Primary outcome: SSI It is uncertain whether wound exposure or any dressing reduces or increases the risk of SSI compared with alternative options investigated: we assessed the certainty of evidence as very low for most comparisons (and low for others), with downgrading (according to GRADE criteria) largely due to risk of bias and imprecision. We summarise the results of comparisons with meta-analysed data below: - film dressings compared with basic wound contact dressings following clean surgery (RR 1.34, 95% CI 0.70 to 2.55), very low certainty evidence downgraded once for risk of bias and twice for imprecision. - hydrocolloid dressings compared with basic wound contact dressings following clean surgery (RR 0.91, 95% CI 0.30 to 2.78), very low certainty evidence downgraded once for risk of bias and twice for imprecision. - hydrocolloid dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.57, 95% CI 0.22 to 1.51), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. - silver-containing dressings compared with basic wound contact dressings following clean surgery (RR 1.11, 95% CI 0.47 to 2.62), very low certainty evidence downgraded once for risk of bias and twice for imprecision. - silver-containing dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.83, 95% CI 0.51 to 1.37), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. Secondary outcomes There was limited and low or very low certainty evidence on secondary outcomes such as scarring, acceptability of dressing and ease of removal, and uncertainty whether wound dressings influenced these outcomes. Authors' conclusions It is uncertain whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI, or whether any particular wound dressing is more effective than others in reducing the risk of SSI, improving scarring, reducing pain, improving acceptability to patients, or is easier to remove. Most studies in this review were small and at a high or unclear risk of bias. Based on the current evidence, decision makers may wish to base decisions about how to dress a wound following surgery on dressing costs as well as patient preference

Adjuvant chemotherapy of ovarian cancer using paclitaxel/cisplatin protocol in women over 70 – analysis of treatment course and toxicity

Aim of paper: Analysis of clinical course of 1st line chemotherapy acc. to paclitaxel/cisplatin protocol in women over 70 with ovarian cancer. Secondary endpoint was treatment-related toxicity in this population of patients. Material and method: This retrospective study included 25 patients over 70 with confirmed diagnosis of ovarian cancer at the beginning of their therapy (study group) and 25 patients under 70 continuing their therapy (control group). All patients underwent primary surgery and received adjuvant chemotherapy (paclitaxel 135 mg/m2 and cisplatin 75 mg/m2). Treatmentrelated toxicity was assessed using Common Terminology Criteria for Adverse Events v. 3.0 (CTCAE). Results: Patients in both groups did not differ significantly in clinical stage of their disease. Women in the study group presented a significantly higher proportion of poorly differentiated ovarian cancer as compared with controls. Baseline mean CA-125 level was similar in both groups. No significant intergroup differences occurred concerning the number of chemotherapy cycles delivered or mortality rate during the therapy. Proportion of patients requiring delay or cessation of treatment was similar in both groups. No significant difference was observed in remission rates between study and control groups. Incidence of hematologic complications, renal failure, neurotoxicity and hepatotoxicity was similar in both groups. No cardiologic complications were noticed in this population of patients and proportion of patients who required blood transfusion was similar in both groups. Conclusions: Course of treatment, toxicity and clinical response are not age-dependent in patients with ovarian cancer receiving paclitaxel/cisplatin protocol.Cel: Analiza przebiegu chemioterapii I rzutu z wykorzystaniem schematu paklitaksel/cisplatyna u kobiet powyżej 70. roku życia chorujących na raka jajnika. Dodatkowo oceniano toksyczność tego leczenia w badanej grupie pacjentek. Materiał i metody: Badaniem retrospektywnym objęto grupę 25 pacjentek z rozpoznanym rakiem jajnika, które miały ponad 70 lat w momencie rozpoczęcia terapii (grupa badana), oraz grupę 25 pacjentek w wieku poniżej 70 lat w trakcie trwania terapii (grupa kontrolna). Pacjentki z obu grup zostały poddane pierwotnemu zabiegowi operacyjnemu i następowej chemioterapii: paklitakselem (135 mg/m2) i cisplatyną (75 mg/m2). Toksyczność terapii oceniano według Common Terminology Criteria for Adverse Events v. 3.0 (CTCAE). Wyniki: Pacjentki z obu grup nie różniły się znamiennie w odniesieniu do stopnia klinicznego zaawansowania. U kobiet z grupy badanej odnotowano istotny wzrost odsetka raka jajnika o niskim stopniu histologicz nego zróżnicowania w porównaniu z grupą kontrolną. Średnie stężenie markera CA-125 przed rozpoczęciem leczenia było podobne w obu grupach. Nie stwierdzono istotnych statystycznie różnic pomiędzy grupami w odniesieniu do liczby podanych cykli chemioterapii oraz odsetka zgonów w trakcie terapii. Odsetek pacjentek wymagających czasowego przerwania terapii lub odstąpienia od jej kontynuowania był podobny w obu grupach. Wśród pacjentek z grupy badanej w porównaniu z grupą kontrolną nie wykazano znamiennej statystycznie różnicy w odniesieniu do odsetka pacjentek, które osiągnęły remisję. Częstość występowania powikłań hematologicznych, niewydolności nerek, neurotoksyczności i hepatotoksyczności była podobna w obu grupach. W obu grupach nie stwierdzono występowania powikłań kardiologicznych. Odsetek pacjentek wymagających transfuzji krwi w obu grupach był podobny. Wnioski: Przebieg i toksyczność terapii oraz odpowiedź kliniczna nie są czynnikami zależnymi od wieku pacjentki podczas stosowania schematu paklitaksel/cisplatyna w leczeniu raka jajnika

Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial

IntroductionGestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%–10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.Methods and analysisThis is a prospective, randomised study, that will recruit 100 women at 24–28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.Ethics and disseminationThe study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.Trial registration numberNCT04422821.</jats:sec

Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial

Introduction Gestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%–10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.Methods and analysis This is a prospective, randomised study, that will recruit 100 women at 24–28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.Ethics and dissemination The study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.Trial registration number NCT04422821

Maturity-onset Diabetes of the Young (MODY) in Pregnancy: A Review

Abstract: Hyperglycaemia in pregnancy is one of the most common complications of pregnancy and is generally diagnosed as gestational diabetes mellitus (GDM). Nevertheless, clinical symptoms of hyperglycaemia in pregnancy in some cases do not match the clinical manifestations of GDM. It is suspected that 1-2 % of women diagnosed with GDM are misdiagnosed maturity-onset diabetes of the young (MODY). MODY often has a subclinical course; thus, it is challenging for clinicians to aptly diagnose monogenic diabetes in pregnancy. Proper diagnosis is crucial for the effective treatment of hyperglycaemia in pregnancy. Many studies revealed that misdiagnosis of MODY increases the rate of complications for both mother and fetus. This literature review reports the current knowledge regarding diagnosis, treatment, and complications of the most common types of MODY in pregnancy. </jats:sec