Fetal volume measurements in the first trimester of pregnancy with three-dimensional ultrasound

Preterm birth and a low birth weight are major complications with significant consequences for families and society. It is expected that these complications are the result of the intra-uterine conditions in the first trimester of pregnancy. If it would be possible to detect the fetus at risk early in pregnancy, then the obstetric care can be adjusted accordingly. Earlier reports suggested that fetal growth in the first trimester of pregnancy is of significant value in assessing these complications in pregnancy, the clinical value of these findings is unknown because of the small differences between normal and abnormal growth (Chapter 1). If the fetal size is measured with routine two-dimensional ultrasound, the differences between normal and abnormal fetal size are small. The extra third dimension with three-dimensional ultrasound is expected to give more information about fetal development. The fetal volume rises seven times faster than the crown-rump-length (routine two-dimensional measurement), so impaired fetal growth will be more obvious. This thesis describes in vitro and in vivo studies in order to analyze the still rather complex volume measurements with three-dimensional ultrasound. Furthermore the predictive value of fetal volume measurements in relation to pregnancy outcome is discussed. In vitro studies Three-dimensional volume measurements are expected to be of diagnostic value in general gynecologic and obstetric practice. Despite that the introduction of volume measurements with VOCAL (Volume Organ Computer Aided AnaLysis) was an advancement, the volume measurements are still rather time consuming and complex, as explained in Chapter 1. The learning curve for volume measurements with three-dimensional ultrasound and VOCAL were analyzed in Chapter 2. There is no significant learning curve for volume measurements with three-dimensional ultrasound. In addition, the measurements from inexperienced sonographers were similar to those of an expert. Chapter 3 describes the relation between the volume of an object and the measurement error in vitro for a range of volumes that are comparable to actual fetal volumes in the first trimester of pregnancy. The results show that the percentage error, i.e. absolute measurement error expressed as a percentage of the actual volume, was smaller for larger objects. One should be aware of the volume-dependent absolute and percentage measurement error when interpreting the measured values. Explorative research in order to develop and verify a more practical semi-automated method for volume calculations with 3DUS images is evaluated in Chapter 4. The results of this study show that mathematical volume calculations are possible with the newly developed semi-automated method. This method was successfully applied on a first trimester fetus, where the points of interest at the contour of the fetal head and body were detected. We also succeeded in detecting voxels in the whole contour, including the limbs, of a first trimester fetus with a gestational age of 12 weeks. In vivo studies The high inter- and intra-observer reliability of abdominal fetal volume measurements with three-dimensional ultrasound measurements of the fetal head and rump, i.e. an inter- and intra-class correlation of 0.934 and 0.994, respectively is discussed in Chapter 5. Because of all these promising results, a prospective cohort study was performed to determine whether it is possible to detect a fetus at risk for preterm birth and/or low birth weight by measuring the fetal volume with three-dimensional ultrasound in the first trimester of pregnancy, of which the study protocol is described in Chapter 6. The results of this prospective cohort study are reported in Chapter 7. The difference in mean percentage error between normal and complicated pregnancies (preterm birth and/or low birth weight) was neither significant nor clinically relevant. The fetal volumes of the neonates born after preterm birth and/or low birth weight are distributed throughout the range of the neonates born a normal birth weight, indicating that it is hard to distinguish the complicated pregnancies from the normal ones by fetal volume alone. Analysis for CRL as a predictor of a low birth weight and the analysis with the individual growth curves showed results similar to the original analysis, i.e. no significant or clinically relevant differences between the normal and complicated group. In conclusion, the measurement of the three-dimensional fetal volume in the first trimester of pregnancy is, by itself, not useful for detecting pregnancies at risk for preterm birth and/or low birth weight. The combination with biochemical markers can be subject of future research. If fetal volume measurements appears to be useful after all, then we know that there is no learning curve for the volume measurements with three-dimensional ultrasound and that the inter- and intraobserver reliability of these measurements are good. Further research concerning automated volume measurements or automated detection of the expected fetal shape might be helpful in pregnancy dating and detection of congenital anomalies

In-vitro volumeberekening met behulp van driedimensionale echoscopie

Driedimensionale echoscopie neemt toe in populariteit.De klinische relevantie van driedimensionale echoscopie voor de verloskunde is echter niet bewezen. Wij veronderstellen dat de mogelijkheid van volumemetingen een meerwaarde zal opleveren voor de klinische praktijk. De standaard gebruikte handmatige methode is bewerkelijk en afhankelijk van de ervaring van de onderzoeker. Het is gelukt een semigeautomatiseerde methode voor volumeberekeningen te ontwikkelen. Deze methode is reproduceerbaar en lijkt betrouwbaar. In dit artikel worden de resultaten besproken van een pilotstudy

Fetal volume measurements in the first trimester of pregnancy with three-dimensional ultrasound

Preterm birth and a low birth weight are major complications with significant consequences for families and society. It is expected that these complications are the result of the intra-uterine conditions in the first trimester of pregnancy. If it would be possible to detect the fetus at risk early in pregnancy, then the obstetric care can be adjusted accordingly. Earlier reports suggested that fetal growth in the first trimester of pregnancy is of significant value in assessing these complications in pregnancy, the clinical value of these findings is unknown because of the small differences between normal and abnormal growth (Chapter 1). If the fetal size is measured with routine two-dimensional ultrasound, the differences between normal and abnormal fetal size are small. The extra third dimension with three-dimensional ultrasound is expected to give more information about fetal development. The fetal volume rises seven times faster than the crown-rump-length (routine two-dimensional measurement), so impaired fetal growth will be more obvious. This thesis describes in vitro and in vivo studies in order to analyze the still rather complex volume measurements with three-dimensional ultrasound. Furthermore the predictive value of fetal volume measurements in relation to pregnancy outcome is discussed. In vitro studies Three-dimensional volume measurements are expected to be of diagnostic value in general gynecologic and obstetric practice. Despite that the introduction of volume measurements with VOCAL (Volume Organ Computer Aided AnaLysis) was an advancement, the volume measurements are still rather time consuming and complex, as explained in Chapter 1. The learning curve for volume measurements with three-dimensional ultrasound and VOCAL were analyzed in Chapter 2. There is no significant learning curve for volume measurements with three-dimensional ultrasound. In addition, the measurements from inexperienced sonographers were similar to those of an expert. Chapter 3 describes the relation between the volume of an object and the measurement error in vitro for a range of volumes that are comparable to actual fetal volumes in the first trimester of pregnancy. The results show that the percentage error, i.e. absolute measurement error expressed as a percentage of the actual volume, was smaller for larger objects. One should be aware of the volume-dependent absolute and percentage measurement error when interpreting the measured values. Explorative research in order to develop and verify a more practical semi-automated method for volume calculations with 3DUS images is evaluated in Chapter 4. The results of this study show that mathematical volume calculations are possible with the newly developed semi-automated method. This method was successfully applied on a first trimester fetus, where the points of interest at the contour of the fetal head and body were detected. We also succeeded in detecting voxels in the whole contour, including the limbs, of a first trimester fetus with a gestational age of 12 weeks. In vivo studies The high inter- and intra-observer reliability of abdominal fetal volume measurements with three-dimensional ultrasound measurements of the fetal head and rump, i.e. an inter- and intra-class correlation of 0.934 and 0.994, respectively is discussed in Chapter 5. Because of all these promising results, a prospective cohort study was performed to determine whether it is possible to detect a fetus at risk for preterm birth and/or low birth weight by measuring the fetal volume with three-dimensional ultrasound in the first trimester of pregnancy, of which the study protocol is described in Chapter 6. The results of this prospective cohort study are reported in Chapter 7. The difference in mean percentage error between normal and complicated pregnancies (preterm birth and/or low birth weight) was neither significant nor clinically relevant. The fetal volumes of the neonates born after preterm birth and/or low birth weight are distributed throughout the range of the neonates born a normal birth weight, indicating that it is hard to distinguish the complicated pregnancies from the normal ones by fetal volume alone. Analysis for CRL as a predictor of a low birth weight and the analysis with the individual growth curves showed results similar to the original analysis, i.e. no significant or clinically relevant differences between the normal and complicated group. In conclusion, the measurement of the three-dimensional fetal volume in the first trimester of pregnancy is, by itself, not useful for detecting pregnancies at risk for preterm birth and/or low birth weight. The combination with biochemical markers can be subject of future research. If fetal volume measurements appears to be useful after all, then we know that there is no learning curve for the volume measurements with three-dimensional ultrasound and that the inter- and intraobserver reliability of these measurements are good. Further research concerning automated volume measurements or automated detection of the expected fetal shape might be helpful in pregnancy dating and detection of congenital anomalies

Volume-related measurement error by three-dimensional ultrasound with a rotational multiplanar technique

Background: The goal of this study was to calculate the accuracy of three-dimensional volume measurements with the rotational multiplanar technique VOCAL (Volume Organ Computer-aided AnaLysis). Methods: An ultrasound phantom with 13 objects (volume 10.2–40.5 cm3) was created. After data acquisition, the volumes of the objects were measured with the VOCAL technique. Results: A linear mixed model analysis showed a significant linear (B = –0.008, 95% CI –0.014, –0.002, p = 0.005) and a significant quadratic trend (B = 0.0001, 95% CI 0.000004, 0.0002, p = 0.040). The absolute error increases significantly with the increasing volume of interest with 0.044 cm3 for each cm3 rise of the volume of interest. The actual volume increased from an initial value of 10 cm3 to values of 20, 30 and 40 cm3, resulting in a decrease in the mean estimated percentage error from 15.4 to 10.6%, 8.0% and 7.5%. Conclusion: The results of this study showed that volume measurements with three-dimensional ultrasound and the VOCAL software can be used for volume measurements in vivo. However, it is important to assess the measurement error and to consider these error values when interpreting the results in daily practice

Identification of barriers and facilitators for optimal cesarean section care: perspective of professionals

Contains fulltext : 177366.pdf (publisher's version ) (Open Access)BACKGROUND: The cesarean section (CS) rate has increased over recent decades with poor guideline adherence as a possible cause. The objective of this study was to explore barriers and facilitators for delivering optimal care as described in clinical practice guidelines. METHODS: Key recommendations from evidence-based guidelines were used as a base to explore barriers and facilitators for delivering optimal CS care in The Netherlands. Both focus group and telephone interviews among 29 different obstetrical professionals were performed. Transcripts from the interviews were analysed. Barriers and facilitators were identified and categorised in six domains according to the framework developed by Grol: the guideline recommendations (I), the professional (II), the patient (III), the social context (IV), the organizational context (V) and the financial/legislation context (VI). RESULTS: Most barriers were found in the professional and organizational domain. Barriers mentioned by healthcare professionals were disagreement with specific guideline recommendations, and hesitation to allow women to be part of the decision making process. Other barriers are lack of adequately trained personal staff, lack of collaboration between professionals, and lack of technical equipment. CONCLUSIONS: Clear facilitators and barriers for guideline adherence were identified in all domains. Several barriers may be addressed by using decision aids on mode of birth or prediction models to individualise care in women in whom both planned vaginal birth and CS are equal options. In women with an intended vaginal birth, adequate staffing and the availability of both fetal blood sampling and epidural analgesia are important

Vaginal hysterectomy versus vaginal assisted NOTES hysterectomy (VANH): a protocol for a randomised controlled trial

Introduction Natural Orifice Transluminal Endoscopic Surgery is a minimal invasive technique using natural body orifices like the vagina. Benefits of a vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less blood loss, shorter surgery time and it allows more women to undergo a hysterectomy in a day-care setting compared with the total laparoscopic hysterectomy. Trials comparing vaginal hysterectomy (VH) and VANH are lacking. The aim of this study is to compare hysterectomy by VANH versus VH for same-day discharge (SDD), complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Methods and analysis The study is a single-blinded, multicentre, randomised controlled trial. Eligible women with benign indication for hysterectomy will be randomly allocated to the VH (control) group or the VANH (intervention) group. The primary outcome is SDD. We calculated a sample size of 124 women assuming 27% SDD difference with an alpha of 0.05 and power of 0.8. A total of 83 patients will be included in the VANH-group and 41 patients in the VH-group, using an enrolment ratio of 2:1. Secondary outcomes are; surgery-related complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Ethics and dissemination The study was approved on 27 May 2021 by the Ethics Committee of the Zuyderland Medical Centre Heerlen. The first patient was randomised on 8 July 2021. The last participant randomised should be treated before 31 December 2022. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment

Vaginal hysterectomy versus vaginal assisted NOTES hysterectomy (VANH): a protocol for a randomised controlled trial

Introduction Natural Orifice Transluminal Endoscopic Surgery is a minimal invasive technique using natural body orifices like the vagina. Benefits of a vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less blood loss, shorter surgery time and it allows more women to undergo a hysterectomy in a day-care setting compared with the total laparoscopic hysterectomy. Trials comparing vaginal hysterectomy (VH) and VANH are lacking. The aim of this study is to compare hysterectomy by VANH versus VH for same-day discharge (SDD), complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Methods and analysis The study is a single-blinded, multicentre, randomised controlled trial. Eligible women with benign indication for hysterectomy will be randomly allocated to the VH (control) group or the VANH (intervention) group. The primary outcome is SDD. We calculated a sample size of 124 women assuming 27% SDD difference with an alpha of 0.05 and power of 0.8. A total of 83 patients will be included in the VANH-group and 41 patients in the VH-group, using an enrolment ratio of 2:1. Secondary outcomes are; surgery-related complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Ethics and dissemination The study was approved on 27 May 2021 by the Ethics Committee of the Zuyderland Medical Centre Heerlen. The first patient was randomised on 8 July 2021. The last participant randomised should be treated before 31 December 2022. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

BACKGROUND: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding.OBJECTIVE: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding.STUDY DESIGN: This multicenter, randomized controlled, non inferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function.RESULTS: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P1/4.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups.CONCLUSION: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrelreleasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments