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1.  The HAPPY study (Holistic Approach to Pregnancy and the first Postpartum Year): design of a large prospective cohort study 
The HAPPY study is a large prospective longitudinal cohort study in which pregnant women (N ≈ 2,500) are followed during the entire pregnancy and the whole first year postpartum. The study collects a substantial amount of psychological and physiological data investigating all kinds of determinants that might interfere with general well-being during pregnancy and postpartum, with special attention to the effect of maternal mood, pregnancy-related somatic symptoms (including nausea and vomiting (NVP) and carpal tunnel syndrome (CTS) symptoms), thyroid function, and human chorionic gonadotropin (HCG) on pregnancy outcome of mother and foetus.
During pregnancy, participants receive questionnaires at 12, 22 and 32 weeks of gestation. Apart from a previous obstetric history, demographic features, distress symptoms, and pregnancy-related somatic symptoms are assessed. Furthermore, obstetrical data of the obstetric record form and ultrasound data are collected during pregnancy. At 12 and 30 weeks, thyroid function is assessed by blood analysis of thyroid stimulating hormone (TSH), free thyroxine (FT4) and thyroid peroxidase antibodies (TPO-Ab), as well as HCG. Also, depression is assessed with special focus on the two key symptoms: depressed mood and anhedonia. After childbirth, cord blood, neonatal heel screening results and all obstetrical data with regard to start of labour, mode of delivery and complications are collected. Moreover, mothers receive questionnaires at one week, six weeks, four, eight, and twelve months postpartum, to investigate recovery after pregnancy and delivery, including postpartum mood changes, emotional distress, feeding and development of the newborn.
The key strength of this large prospective cohort study is the holistic (multifactorial) approach on perinatal well-being combined with a longitudinal design with measurements during all trimesters of pregnancy and the whole first year postpartum, taking into account two physiological possible markers of complaints and symptoms throughout gestation: thyroid function and HCG. The HAPPY study is among the first to investigate within one design physiological and psychological aspects of NVP and CTS symptoms during pregnancy. Finally, the concept of anhedonia and depressed mood as two distinct aspects of depression and its possible relation on obstetric outcome, breastfeeding, and postpartum well-being will be studied.
PMCID: PMC4162933  PMID: 25201155
Pregnancy; Maternal well-being; Trimester specific symptoms; Distress; Depression; Thyroid function; Delivery; Childbirth; Postpartum; Breastfeeding
2.  The impact of transmural multiprofessional simulation-based obstetric team training on perinatal outcome and quality of care in the Netherlands 
BMC Medical Education  2014;14:175.
Perinatal mortality and morbidity in the Netherlands is relatively high compared to other European countries. Our country has a unique system with an independent primary care providing care to low-risk pregnancies and a secondary/tertiary care responsible for high-risk pregnancies. About 65% of pregnant women in the Netherlands will be referred from primary to secondary care implicating multiple medical handovers. Dutch audits concluded that in the entire obstetric collaborative network process parameters could be improved. Studies have shown that obstetric team training improves perinatal outcome and that simulation-based obstetric team training implementing crew resource management (CRM) improves team performance. In addition, deliberate practice (DP) improves medical skills. The aim of this study is to analyse whether transmural multiprofessional simulation-based obstetric team training improves perinatal outcome.
The study will be implemented in the south-eastern part of the Netherlands with an annual delivery rate of over 9,000. In this area secondary care is provided by four hospitals. Each hospital with referring primary care practices will form a cluster (study group). Within each cluster, teams will be formed of different care providers representing the obstetric collaborative network. CRM and elements of DP will be implemented in the training. To analyse the quality of care as perceived by patients, the Pregnancy and Childbirth Questionnaire (PCQ) will be used. Furthermore, self-reported collaboration between care providers will be assessed. Team performance will be measured by the Clinical Teamwork Scale (CTS). We employ a stepped-wedge trial design with a sequential roll-out of the trainings for the different study groups.
Primary outcome will be perinatal mortality and/or admission to a NICU. Secondary outcome will be team performance, quality of care as perceived by patients, and collaboration among care providers.
The effect of transmural multiprofessional simulation-based obstetric team training on perinatal outcome has never been studied. We hypothesise that this training will improve perinatal outcome, team performance, and quality of care as perceived by patients and care providers.
Trial registration
The Netherlands National Trial Register,, registered June 1, 2014
PMCID: PMC4236579  PMID: 25145317
Multiprofessional; Simulation-based obstetric team training; Deliberate practice; Crew resource management; Quality of care
3.  Study protocol: PoPE-Prediction of Preterm delivery by Electrohysterography 
Traditional methods used for prediction of preterm delivery are subjective and inaccurate. The Electrohysterogram (EHG) and in particular the estimation of the EHG conduction velocity, is a relatively new promising method for detecting imminent preterm delivery. To date the analysis of the conduction velocity has relied on visual inspection of the signals. As a next step towards the introduction of EHG analysis as a clinical tool, we propose an automated method for EHG conduction velocity estimation for both the speed and direction of single spike propagation.
The study design will be an observational cohort study. 100 pregnant women, gestational age between 23 + 5 and 34 weeks, admitted for threatening preterm labor or preterm prelabor rupture of membranes, will be included. The length of the cervical canal will be measured by transvaginal ultrasound. The EHG will be recorded using 4 electrodes in a fixed configuration. Contractions will be detected by analysis of the EHG and using an estimation of the intra uterine pressure. In the selected contractions, the delays between channels will be estimated by cross-correlation, and subsequently, the average EHG conduction velocity will be derived. Patients will be classified as labor group and non-labor group based on the time between measurement and delivery. The average conduction velocity and cervical length will be compared between the groups. The main study endpoints will be sensitivity, specificity, and area under the ROC curve for delivery within 1,2,4,7, and 14 days from the measurement.
In this study, the diagnostic accuracy of EHG conduction velocity analysis will be evaluated for detecting preterm labor. Visual and automatic detection of contractions will be compared. Planar wave propagation will be assumed for the calculation of the CV vector.
Trial registration
Current Controlled Trials ISRCTN07603227.
PMCID: PMC4057931  PMID: 24898548
Preterm birth; Labor & delivery; Electrohysterogram; Uterine electromyography; Imaging in obs & gyn
4.  Automated Conduction Velocity Analysis in the Electrohysterogram for Prediction of Imminent Delivery: A Preliminary Study 
Background. Analysis of the electrohysterogram (EHG) is a promising diagnostic tool for preterm delivery. For the introduction in the clinical practice, analysis of the EHG should be reliable and automated to guarantee reproducibility. Study Goal. Investigating the feasibility of automated analysis of the EHG conduction velocity (CV) for detecting imminent delivery. Materials and Methods. Twenty-two patients presenting with uterine contractions (7 preterm) were included. An EHG was obtained noninvasively using a 64-channel high-density electrode grid. Contractions were selected based on the estimated intrauterine pressure derived from the EHG, the tocodynamometer, and maternal perception. Within the selected contractions, the CV vector was identified in two dimensions. Results. Nine patients delivered within 24 hours and were classified as a labor group. 64 contractions were analyzed; the average amplitude of the CV vector was significantly higher for the labor group, 8.65 cm/s ± 1.90, compared to the nonlabor group, 5.30 cm/s ± 1.47 (P < 0.01). Conclusion. The amplitude of the CV is a promising parameter for predicting imminent (preterm) delivery. Automated estimation of this parameter from the EHG signal is feasible and should be regarded as an important prerequisite for future clinical studies and applications.
PMCID: PMC3891613  PMID: 24489602
5.  Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study 
To investigate the relation between maternal thyroid function and the outcome of external cephalic version (ECV) in breech presentation.
Prospective cohort study in 141 women (≥ 35 weeks gestation) with a singleton fetus in breech. Blood samples for assessing thyroid function were taken prior to ECV. Main outcome measure was the relation between maternal thyroid function and ECV outcome indicated by post ECV ultrasound.
ECV success rate was 77/141 (55%), 41/48 (85%) in multipara and 36/93 (39%) in primipara. Women with a failed ECV attempt had significantly higher TSH concentrations than women with a successful ECV (p < 0.001). Multiple logistic regression showed that TSH (OR: 0.52, 95% CI: 0.30-0.90), nulliparity (OR: 0.11, 95% CI: 0.03-0.36), frank breech (OR: 0.30, 95% CI: 0.10-0.93) and placenta anterior (OR: 0.31, 95% CI: 0.11-0.85) were independently related to ECV success.
Higher TSH levels increase the risk of ECV failure.
Trial registration number NCT00516555
PMCID: PMC3042424  PMID: 21269431
6.  Reducing errors in health care: cost-effectiveness of multidisciplinary team training in obstetric emergencies (TOSTI study); a randomised controlled trial 
There are many avoidable deaths in hospitals because the care team is not well attuned. Training in emergency situations is generally followed on an individual basis. In practice, however, hospital patients are treated by a team composed of various disciplines. To prevent communication errors, it is important to focus the training on the team as a whole, rather than on the individual. Team training appears to be important in contributing toward preventing these errors. Obstetrics lends itself to multidisciplinary team training. It is a field in which nurses, midwives, obstetricians and paediatricians work together and where decisions must be made and actions must be carried out under extreme time pressure.
It is attractive to belief that multidisciplinary team training will reduce the number of errors in obstetrics. The other side of the medal is that many hospitals are buying expensive patient simulators without proper evaluation of the training method. In the Netherlands many hospitals have 1,000 or less annual deliveries. In our small country it might therefore be more cost-effective to train obstetric teams in medical simulation centres with well trained personnel, high fidelity patient simulators, and well defined training programmes.
The aim of the present study is to evaluate the cost-effectiveness of multidisciplinary team training in a medical simulation centre in the Netherlands to reduce the number of medical errors in obstetric emergency situations. We plan a multicentre randomised study with the centre as unit of analysis. Obstetric departments will be randomly assigned to receive multidisciplinary team training in a medical simulation centre or to a control arm without any team training.
The composite measure of poor perinatal and maternal outcome in the non training group was thought to be 15%, on the basis of data obtained from the National Dutch Perinatal Registry and the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG). We anticipated that multidisciplinary team training would reduce this risk to 5%. A sample size of 24 centres with a cluster size of each at least 200 deliveries, each 12 centres per group, was needed for 80% power and a 5% type 1 error probability (two-sided). We assumed an Intraclass Correlation Coefficient (ICC) value of maximum 0.08.
The analysis will be performed according to the intention-to-treat principle and stratified for teaching or non-teaching hospitals.
Primary outcome is the number of obstetric complications throughout the first year period after the intervention. If multidisciplinary team training appears to be effective a cost-effective analysis will be performed.
If multidisciplinary team training appears to be cost-effective, this training should be implemented in extra training for gynaecologists.
Trial Registration
The protocol is registered in the clinical trial register number NTR1859
PMCID: PMC2964561  PMID: 20932293
7.  A randomised clinical trial on cardiotocography plus fetal blood sampling versus cardiotocography plus ST-analysis of the fetal electrocardiogram (STAN®) for intrapartum monitoring 
Cardiotocography (CTG) is worldwide the method for fetal surveillance during labour. However, CTG alone shows many false positive test results and without fetal blood sampling (FBS), it results in an increase in operative deliveries without improvement of fetal outcome. FBS requires additional expertise, is invasive and has often to be repeated during labour. Two clinical trials have shown that a combination of CTG and ST-analysis of the fetal electrocardiogram (ECG) reduces the rates of metabolic acidosis and instrumental delivery. However, in both trials FBS was still performed in the ST-analysis arm, and it is therefore still unknown if the observed results were indeed due to the ST-analysis or to the use of FBS in combination with ST-analysis.
We aim to evaluate the effectiveness of non-invasive monitoring (CTG + ST-analysis) as compared to normal care (CTG + FBS), in a multicentre randomised clinical trial setting. Secondary aims are: 1) to judge whether ST-analysis of fetal electrocardiogram can significantly decrease frequency of performance of FBS or even replace it; 2) perform a cost analysis to establish the economic impact of the two treatment options.
Women in labour with a gestational age ≥ 36 weeks and an indication for CTG-monitoring can be included in the trial.
Eligible women will be randomised for fetal surveillance with CTG and, if necessary, FBS or CTG combined with ST-analysis of the fetal ECG.
The primary outcome of the study is the incidence of serious metabolic acidosis (defined as pH < 7.05 and Bdecf > 12 mmol/L in the umbilical cord artery). Secondary outcome measures are: instrumental delivery, neonatal outcome (Apgar score, admission to a neonatal ward), incidence of performance of FBS in both arms and cost-effectiveness of both monitoring strategies across hospitals.
The analysis will follow the intention to treat principle. The incidence of metabolic acidosis will be compared across both groups. Assuming a reduction of metabolic acidosis from 3.5% to 2.1 %, using a two-sided test with an alpha of 0.05 and a power of 0.80, in favour of CTG plus ST-analysis, about 5100 women have to be randomised. Furthermore, the cost-effectiveness of CTG and ST-analysis as compared to CTG and FBS will be studied.
This study will provide data about the use of intrapartum ST-analysis with a strict protocol for performance of FBS to limit its incidence. We aim to clarify to what extent intrapartum ST-analysis can be used without the performance of FBS and in which cases FBS is still needed.
Trial Registration Number
PMCID: PMC1976105  PMID: 17655764
8.  Effectiveness of the postcoital test: randomised controlled trial 
BMJ : British Medical Journal  1998;317(7157):502-505.
Objectives: To investigate the impact of the postcoital test on the pregnancy rate among subfertile couples and on the number of other diagnostic tests and treatments.
Design: Randomised controlled study.
Setting: A university and two non-university teaching hospitals in the Netherlands.
Subjects: New couples at infertility clinics, 1 March 1993 to 1 October 1995; randomisation to an intervention group (series of infertility investigations that include the postcoital test) or to a control group (series excluding the test).
Main outcome measure: Cumulative pregnancy rate.
Results: Of 736 consecutive new couples, 444 fulfilled the inclusion criteria and consented to participate (intervention group, 227; control group, 217). Treatment was given more often in the intervention group than in the control group (54% v 41%; difference 13% (95% confidence interval 4% to 22%)). Yet cumulative pregnancy rates at 24 months in the intervention group (49% (42% to 55%)) and the control group (48% (42% to 55%)) were closely similar (difference 1% (−9.0% to 9.0%)).
Conclusion: Routine use of the postcoital test in infertility investigations leads to more tests and treatments but has no significant effect on the pregnancy rate.
Key messages The postcoital test dates back to 1866 The test is widely used in infertility investigations but has limited diagnostic potential and poor predictive value Treatments for abnormal test results vary but have not been shown to be effective This first randomised controlled trial comparing infertility investigations with and without the postcoital test showed closely similar cumulative pregnancy rates at 24 months Incorporation of the postcoital test in standard infertility investigations increases the number of tests and treatments but has no effect on the pregnancy rate
PMCID: PMC28641  PMID: 9712594

Results 1-8 (8)