Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial.

BACKGROUND: Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. METHODS: Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: This RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound. TRIAL REGISTRATION: Dutch Trial Register ( NTR5480 ). Registered 29 October 2015.

Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial.

OBJECTIVE: To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage. DESIGN: Randomised non-inferiority trial. SETTING: Thirty-seven Dutch university and general hospitals. POPULATION: Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities. METHODS: Women were allocated to RBC transfusion or non-intervention. MAIN OUTCOME MEASURES: Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum. RESULTS: In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable. CONCLUSIONS: Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.

Impact of particles on sediment accumulation in a drinking water distribution system.

Discolouration of drinking water is one of the main reasons customers complain to their water company. Though corrosion of cast iron is often seen as the main source for this problem, the particles originating from the treatment plant play an important and potentially dominant role in the generation of a discolouration risk in drinking water distribution systems. To investigate this thesis a study was performed in a drinking water distribution system. In two similar isolated network areas the effect of particles on discolouration risk was studied with particle counting, the Resuspension Potential Method (RPM) and assessment of the total accumulated sediment. In the 'Control Area', supplied with normal drinking water, the discolouration risk was regenerated within 1.5 year. In the 'Research Area', supplied with particle-free water, this will take 10-15 years. An obvious remedy for controlling the discolouration risk is to improve the treatment with respect to the short peaks that are caused by particle breakthrough.

Quantitative gated blood pool SPECT for the assessment of coronary artery disease at rest.

BACKGROUND: Planar gated blood pool imaging (GBPI) has long proven to be useful for the noninvasive assessment of ventricular function. From a practical viewpoint, gated blood pool single photon emission computed tomography (GBPS) acquisition can be accomplished in the same time as a three-view planar series, with the benefit of a tomographic perspective that avoids chamber overlap. METHODS AND RESULTS: Quantitative gated blood pool SPECT was applied to 10 patients who underwent coronary arteriography, contrast ventriculography, and planar gated blood pool imaging. For each patient, the mid-short axis oblique slice was divided into 4 discrete segments using 4 different reference models and 2 forms of segmentation. A center of mass (counts) fixed in the end-diastolic frame and segmentation that bisected the ventricular septum proved to have the highest sensitivity and specificity for determining regional wall motion abnormalities at rest in myocardium supplied by severely diseased coronary arteries (>75 %). GBPS correctly identified 19 of 21 abnormal segments (90%), with good specificity (95%), whereas ventriculography identified 12 (57%) and planar GBPI identified 9 (43%) of the segments supplied by diseased coronaries. CONCLUSION: Quantitative GBPS appears to be a sensitive method for assessing coronary artery disease at rest in myocardium perfused by severely diseased coronary arteries.

Tube feeding of cancer patients treated with chemotherapy.

As many chemotherapeutic agents affect the alimentary tract the use of hyperalimentation with tube feeding during and after chemotherapy has been limited. However, patients do tolerate tube feeding well despite chemotherapy. The feeding has to be administered as continuous drip infusion and in case of bone marrow depression sterile feeding is necessary. Enteral nutrition is more physiologic, safer, easier and less expensive than parenteral nutrition. With enteral hyperalimentation the nutritional needs can be fulfilled to a large extent. Much research will be necessary to investigate the effect of enteral (hyper)alimentation on tumor metabolism and clinical effect of chemotherapy.