24 results on '"van Baaren GJ"'
Search Results
2. Child outcomes after induction of labour or expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks of gestation: study protocol of the PPROMEXIL Follow-up trial. A long-term follow-up study of the randomised controlled trials PPROMEXIL and PPROMEXIL-2.
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de Ruigh AA, Simons NE, Van 't Hooft J, van Wassenaer-Leemhuis AG, Aarnoudse-Moens CSH, van Wely M, van Baaren GJ, Vlemmix F, van der Ham DP, van Teeffelen ASP, Mol BW, Roseboom TJ, and Pajkrt E
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- Child, Delivery of Health Care, Female, Follow-Up Studies, Humans, Infant, Newborn, Labor, Induced, Pregnancy, Randomized Controlled Trials as Topic, Fetal Membranes, Premature Rupture therapy, Watchful Waiting
- Abstract
Introduction: Late preterm prelabour rupture of membranes (PROM between 34
+0 and 36+6 weeks gestational age) is an important clinical dilemma. Previously, two large Dutch randomised controlled trials (RCTs) compared induction of labour (IoL) to expectant management (EM). Both trials showed that early delivery does not reduce the risk of neonatal sepsis as compared with EM, although prematurity-related risks might increase. An extensive, structured long-term follow-up of these children has never been performed., Methods and Analysis: The PPROMEXIL Follow-up trial (NL6623 (NTR6953)) aims to assess long-term childhood outcomes of the PPROMEXIL (ISRCTN29313500) and PPROMEXIL-2 trial (ISRCTN05689407), two multicentre RCTs using the same protocol, conducted between 2007 and 2010 evaluating IoL versus EM in women with late preterm PROM. The PPROMEXIL Follow-up will analyse children of mothers with a singleton pregnancy (PPROMEXIL trial n=520, PPROMEXIL-2 trial n=191, total IoL n=359; total EM n=352). At 10-12 years of age all surviving children will be invited for a neurodevelopmental assessment using the Wechsler Intelligence Scale for Children-V, Color-Word Interference Test and the Movement Assessment Battery for Children-2. Parents will be asked to fill out questionnaires assessing behaviour, motor function, sensory processing, respiratory problems, general health and need for healthcare services. Teachers will fill out the Teacher Report Form and answer questions regarding school attainment. For all tests means with SDs will be compared, as well as predefined cut-off scores for abnormal outcome. Sensitivity analyses consisting of different imputation techniques will be used to deal with lost to follow-up., Ethics and Dissemination: The study has been granted approval by the Medical Centre Amsterdam (MEC) of the AmsterdamUMC (MEC2016_217). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results., Trial Registration Number: NL6623 (NTR6953)., Competing Interests: Competing interests: BWM is supported by an NHMRC Practitioner Fellowship (GNT1082548). BWM reports consultancy for ObsEva, Merck Merck KGaA and Guerbet. All other authors did not report any conflicts of interest., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)- Published
- 2021
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3. Cost effectiveness of nifedipine compared with atosiban in the treatment of threatened preterm birth (APOSTEL III trial).
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Nijman T, van Baaren GJ, van Vliet E, Kok M, Gyselaers W, Porath MM, Woiski M, de Boer MA, Bloemenkamp K, Sueters M, Franx A, Mol B, and Oudijk MA
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- Cost-Benefit Analysis, Female, Humans, Nifedipine therapeutic use, Pregnancy, Pregnancy, Multiple, Premature Birth prevention & control, Prenatal Care economics, Tocolytic Agents therapeutic use, Vasotocin economics, Vasotocin therapeutic use, Nifedipine economics, Premature Birth economics, Tocolytic Agents economics, Vasotocin analogs & derivatives
- Abstract
Objective: To assess the cost-effectiveness of treatment with nifedipine compared with atosiban in women with threatened preterm birth., Design: An economic analysis alongside a randomised clinical trial (the APOSTEL III study)., Setting: Obstetric departments of 12 tertiary hospitals and seven secondary hospitals in the Netherlands and Belgium., Population: Women with threatened preterm birth between 25 and 34 weeks of gestation, randomised for tocolysis with either nifedipine or atosiban., Methods: We performed an economic analysis from a societal perspective. We estimated costs from randomisation until discharge. Analyses for singleton and multiple pregnancies were performed separately. The robustness of our findings was evaluated in sensitivity analyses., Main Outcome Measures: Mean costs and differences were calculated per woman treated with nifedipine or atosiban. Health outcomes were expressed as the prevalence of a composite of adverse perinatal outcomes., Results: Mean costs per patients were significantly lower in the nifedipine group [singleton pregnancies: €34,897 versus €43,376, mean difference (MD) -€8479 [95% confidence interval (CI) -€14,327 to -€2016)]; multiple pregnancies: €90,248 versus €102,292, MD -€12,044 (95% CI -€21,607 to € -1671). There was a non-significantly higher death rate in the nifedipine group. The difference in costs was mainly driven by a lower neonatal intensive care unit admission (NICU) rate in the nifedipine group., Conclusion: Treatment with nifedipine in women with threatened preterm birth results in lower costs when compared with treatment with atosiban. However, the safety of nifedipine warrants further investigation., Tweetable Abstract: In women with threatened preterm birth, tocolysis using nifedipine results in lower costs when compared with atosiban., (© 2019 Royal College of Obstetricians and Gynaecologists.)
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- 2019
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4. Cost-effectiveness of diagnostic testing strategies including cervical-length measurement and fibronectin testing in women with symptoms of preterm labor.
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van Baaren GJ, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, Scheepers HCJ, Spaanderman MEA, Bloemenkamp KWM, Haak MC, Bax CJ, Cornette JMJ, Duvekot JJ, Nij Bijvanck BWA, van Eyck J, Franssen MTM, Sollie KM, Vandenbussche FPHA, Woiski M, Bolte AC, van der Post JAM, Bossuyt PMM, Opmeer BC, and Mol BWJ
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- Cohort Studies, Cost-Benefit Analysis, Female, Gestational Age, Hospitalization economics, Hospitalization statistics & numerical data, Humans, Infant, Newborn, Netherlands, Obstetric Labor, Premature diagnosis, Predictive Value of Tests, Pregnancy, Cervical Length Measurement economics, Cervix Uteri chemistry, Fibronectins analysis, Obstetric Labor, Premature economics
- Abstract
Objective: To evaluate the cost-effectiveness of combining cervical-length (CL) measurement and fetal fibronectin (fFN) testing in women with symptoms of preterm labor between 24 and 34 weeks' gestation., Methods: This was a model-based cost-effectiveness analysis evaluating seven test-treatment strategies based on CL measurement and/or fFN testing in women with symptoms of preterm labor from a societal perspective, in which neonatal outcomes and costs were weighted. Estimates of disease prevalence, test accuracy and costs were based on two recently performed nationwide cohort studies in The Netherlands., Results: Strategies using fFN testing and CL measurement separately to predict preterm delivery are associated with higher costs and incidence of adverse neonatal outcomes compared with strategies that combine both tests. Additional fFN testing when CL is 15-30 mm was considered cost effective, leading to a cost saving of €3919 per woman when compared with a treat-all strategy, with a small deterioration in neonatal health outcomes, namely one additional perinatal death and 21 adverse outcomes per 10 000 women with signs of preterm labor (incremental cost-effectiveness ratios €39 million and €1.9 million, respectively). Implementing this strategy in The Netherlands, a country with about 180 000 deliveries annually, could lead to an annual cost saving of between €2.4 million and €7.6 million, with only a small deterioration in neonatal health outcomes., Conclusion: In women with symptoms of preterm labor at 24-34 weeks' gestation, performing additional fFN testing when CL is between 15 and 30 mm is a viable and cost-saving strategy. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd., (Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.)
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- 2018
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5. Comparing induction of labour with oral misoprostol or Foley catheter at term: cost-effectiveness analysis of a randomised controlled multi-centre non-inferiority trial.
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Ten Eikelder M, van Baaren GJ, Oude Rengerink K, Jozwiak M, de Leeuw JW, Kleiverda G, Evers I, de Boer K, Brons J, Bloemenkamp K, and Mol BW
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- Administration, Oral, Adult, Cervical Ripening, Cost-Benefit Analysis, Equivalence Trials as Topic, Female, Humans, Infant, Newborn, Netherlands, Pregnancy, Pregnancy Trimester, Third, Treatment Outcome, Catheterization methods, Delivery, Obstetric, Labor, Induced methods, Misoprostol therapeutic use, Oxytocics therapeutic use
- Abstract
Objective: To assess the costs of labour induction with oral misoprostol versus Foley catheter., Design: Economic evaluation alongside a randomised controlled trial., Setting: Obstetric departments of six tertiary and 23 secondary care hospitals in the Netherlands., Population: Women with a viable term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix (Bishop score <6) without a previous caesarean section, were randomised for labour induction with oral misoprostol (n = 924) or Foley catheter (n = 921)., Methods: We performed economic analysis from a hospital perspective. We estimated direct medical costs associated with healthcare utilisation from randomisation until discharge. The robustness of our findings was evaluated in sensitivity analyses., Main Outcome Measures: Mean costs and differences were calculated per women induced with oral misoprostol or Foley catheter., Results: Mean costs per woman in the oral misoprostol group and Foley catheter group were €4470 versus €4158, respectively [mean difference €312, 95% confidence interval (CI) -€508 to €1063]. Multiple sensitivity analyses did not change these conclusions. However, if cervical ripening for low-risk pregnancies in the Foley catheter group was carried out in an outpatient setting, with admittance to labour ward only at start of active labour, the difference would be €4470 versus €3489, respectively (mean difference €981, 95% CI €225-1817)., Conclusions: Oral misoprostol and Foley catheter generate comparable costs. Cervical ripening outside labour ward with a Foley catheter could potentially save almost €1000 per woman., Tweetable Abstract: Oral misoprostol or Foley catheter for induction of labour generates comparable costs., (© 2017 Royal College of Obstetricians and Gynaecologists.)
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- 2018
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6. Randomized clinical trials are not always the best way to assess diagnostic tests: the case of fetal fibronectin testing.
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van Baaren GJ, Bruijn MMC, and Mol BW
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- 2018
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7. [Fibronectin test in threatened preterm labour: cost-saving but not yet widely implemented in the Netherlands].
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van Winden TMS, Bruijn MMC, Oudijk MA, van Baaren GJ, van Kaam AHLC, Mol BWJ, and Kok M
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- Adult, Costs and Cost Analysis, Female, Humans, Netherlands epidemiology, Predictive Value of Tests, Pregnancy, Retrospective Studies, Fetal Monitoring economics, Fetal Monitoring methods, Fibronectins analysis, Obstetric Labor, Premature diagnosis, Obstetric Labor, Premature economics, Obstetric Labor, Premature epidemiology, Patient Transfer economics
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Objective: Analysis of national implementation of the foetal fibronectin test in the diagnostics of threatened preterm labour in the Netherlands, and indication of the possible obstacles and consequences of implementation or no implementation., Design: National questionnaire, retrospective cohort study and cost-effectiveness calculation., Methods: We approached all hospitals in the Netherlands (n = 86) with a questionnaire on use of the fibronectin test. We also collected data on women who were referred to the Academic Medical Center (AMC), a tertiary care centre in Amsterdam, with symptoms of threatened preterm labour. We investigated whether the referred patients gave birth within 7 days, and whether unnecessary transfer to a centre with a neonatal intensive care unit (NICU) could have been avoided by implementation of the fibronectin test in the referring hospital., Results: The fibronectin test was used in 34% of the hospitals and an additional 17% were in the process of implementation. The most important reasons not to use the fibronectin test were of a financial nature (50%). The cohort study included 96 women who were referred from secondary care. In our cohort, 36% of all transfers could have been avoided by implementation of the fibronectin test in secondary care., Conclusion: The fibronectin test can greatly reduce overtreatment and unnecessary transfer in threatened preterm labour, but implementation remains limited. Costs of the test are an obstacle for the referring hospitals, while implementation prevents unnecessary transport, admission and treatment of pregnant women, giving a potential saving of at least EUR 1,027,930 per year. Inclusion in the Netherlands Society for Obstetrics and Gynaecology (Nederlandse Vereniging voor Obstetrie en Gynaecologie, NVOG) guidelines would be a first step towards wider implementation. Slow implementation exemplifies a more widespread problem: the current reimbursement system does not stimulate such cost-saving innovations.
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- 2018
8. Cost-effectiveness of simulation-based team training in obstetric emergencies (TOSTI study).
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van de Ven J, van Baaren GJ, Fransen AF, van Runnard Heimel PJ, Mol BW, and Oei SG
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- Cost-Benefit Analysis, Female, Humans, Pregnancy, Clinical Competence, Emergencies, Obstetrics education, Patient Care Team, Simulation Training economics
- Abstract
Objective: Team training is frequently applied in obstetrics. We aimed to evaluate the cost-effectiveness of obstetric multi-professional team training in a medical simulation centre., Study Design: We performed a model-based cost-effectiveness analysis to evaluate four strategies for obstetric team training from a hospital perspective (no training, training without on-site repetition and training with 6 month or 3-6-9 month repetition). Data were retrieved from the TOSTI study, a randomised controlled trial evaluating team training in a medical simulation centre. We calculated the incremental cost-effectiveness ratio (ICER), which represent the costs to prevent the adverse outcome, here (1) the composite outcome of obstetric complications and (2) specifically neonatal trauma due to shoulder dystocia., Results: Mean costs of a one-day multi-professional team training in a medical simulation centre were €25,546 to train all personnel of one hospital. A single training in a medical simulation centre was less effective and more costly compared to strategies that included repetition training. Compared to no training, the ICERs to prevent a composite outcome of obstetric complications were €3432 for a single repetition training course on-site six months after the initial training and €5115 for a three monthly repetition training course on-site after the initial training during one year. When we considered neonatal trauma due to shoulder dystocia, a three monthly repetition training course on-site after the initial training had an ICER of €22,878., Conclusion: Multi-professional team training in a medical simulation centre is cost-effective in a scenario where repetition training sessions are performed on-site., (Copyright © 2017 Elsevier B.V. All rights reserved.)
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- 2017
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9. Re: Cervical length screening for prevention of preterm birth in singleton pregnancy with threatened preterm labor: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. V. Berghella, M. Palacio, A. Ness, Z. Alfirevic, K. H. Nicolaides and G. Saccone. Ultrasound Obstet Gynecol 2017; 49: 322-329.
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van Baaren GJ and Mol BW
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- Cerclage, Cervical, Female, Humans, Infant, Newborn, Obstetric Labor, Premature, Pregnancy, Premature Birth prevention & control, Randomized Controlled Trials as Topic
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- 2017
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10. An economic analysis of immediate delivery and expectant monitoring in women with hypertensive disorders of pregnancy, between 34 and 37 weeks of gestation (HYPITAT-II).
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van Baaren GJ, Broekhuijsen K, van Pampus MG, Ganzevoort W, Sikkema JM, Woiski MD, Oudijk MA, Bloemenkamp K, Scheepers H, Bremer HA, Rijnders R, van Loon AJ, Perquin D, Sporken J, Papatsonis D, van Huizen ME, Vredevoogd CB, Brons J, Kaplan M, van Kaam AH, Groen H, Porath M, van den Berg PP, Mol B, Franssen M, and Langenveld J
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- Cost-Benefit Analysis, Female, Gestational Age, Humans, Infant, Newborn, Labor, Induced methods, Netherlands, Pregnancy, Pregnancy Outcome, Respiratory Distress Syndrome, Newborn epidemiology, Respiratory Distress Syndrome, Newborn etiology, Watchful Waiting methods, Health Care Costs statistics & numerical data, Hypertension, Pregnancy-Induced therapy, Labor, Induced economics, Watchful Waiting economics
- Abstract
Objective: To assess the economic consequences of immediate delivery compared with expectant monitoring in women with preterm non-severe hypertensive disorders of pregnancy., Design: A cost-effectiveness analysis alongside a randomised controlled trial (HYPITAT-II)., Setting: Obstetric departments of seven academic hospitals and 44 non-academic hospitals in the Netherlands., Population: Women diagnosed with non-severe hypertensive disorders of pregnancy between 34
0/7 and 370/7 weeks of gestation, randomly allocated to either immediate delivery or expectant monitoring., Methods: A trial-based cost-effectiveness analysis was performed from a healthcare perspective until final maternal and neonatal discharge., Main Outcome Measures: Health outcomes were expressed as the prevalence of respiratory distress syndrome, defined as the need for supplemental oxygen for >24 hours combined with radiographic findings typical for respiratory distress syndrome. Costs were estimated from a healthcare perspective until maternal and neonatal discharge., Results: The average costs of immediate delivery (n = 352) were €10 245 versus €9563 for expectant monitoring (n = 351), with an average difference of €682 (95% confidence interval, 95% CI -€618 to €2126). This 7% difference predominantly originated from the neonatal admissions, which were €5672 in the immediate delivery arm and €3929 in the expectant monitoring arm., Conclusion: In women with mild hypertensive disorders between 340/7 and 370/7 weeks of gestation, immediate delivery is more costly than expectant monitoring as a result of differences in neonatal admissions. These findings support expectant monitoring, as the clinical outcomes of the trial demonstrated that expectant monitoring reduced respiratory distress syndrome for a slightly increased risk of maternal complications., Tweetable Abstract: Expectant management in preterm hypertensive disorders is less costly compared with immediate delivery., (© 2016 Royal College of Obstetricians and Gynaecologists.)- Published
- 2017
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11. Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?
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Bruijn MM, Hermans FJ, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, Oei G, Scheepers HC, Spaanderman ME, Bloemenkamp KW, Haak MC, Bolte AC, Vandenbussche FP, Woiski MD, Bax CJ, Cornette JM, Duvekot JJ, Bijvank BW, van Eyck J, Franssen MT, Sollie KM, van der Post JA, Bossuyt PM, Kok M, Mol BW, and van Baaren GJ
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- Adult, Coitus, Endosonography, False Negative Reactions, False Positive Reactions, Female, Gestational Age, Humans, Obstetric Labor, Premature metabolism, Pregnancy, Risk Factors, Soaps, Uterine Hemorrhage metabolism, Young Adult, Fibronectins analysis, Obstetric Labor, Premature diagnosis, Vagina chemistry
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Objective We assessed the influence of external factors on false-positive, false-negative, and invalid fibronectin results in the prediction of spontaneous delivery within 7 days. Methods We studied symptomatic women between 24 and 34 weeks' gestational age. We performed uni- and multivariable logistic regression to estimate the effect of external factors (vaginal soap, digital examination, transvaginal sonography, sexual intercourse, vaginal bleeding) on the risk of false-positive, false-negative, and invalid results, using spontaneous delivery within 7 days as the outcome. Results Out of 708 women, 237 (33%) had a false-positive result; none of the factors showed a significant association. Vaginal bleeding increased the proportion of positive fetal fibronectin (fFN) results, but was significantly associated with a lower risk of false-positive test results (odds ratio [OR], 0.22; 95% confidence intervals [CI], 0.12-0.39). Ten women (1%) had a false-negative result. None of the investigated factors was significantly associated with a significantly higher risk of false-negative results. Twenty-one tests (3%) were invalid; only vaginal bleeding showed a significant association (OR, 4.5; 95% CI, 1.7-12). Conclusion The effect of external factors on the performance of qualitative fFN testing is limited, with vaginal bleeding as the only factor that reduces its validity., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
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- 2017
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12. Prediction of progression to severe disease in women with late preterm hypertensive disorders of pregnancy.
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Zwertbroek EF, Broekhuijsen K, Langenveld J, van Baaren GJ, van den Berg PP, Bremer HA, Ganzevoort W, van Loon AJ, Mol BW, van Pampus MG, Perquin DA, Rijnders RJ, Scheepers HC, Sikkema MJ, Woiski MD, Groen H, and Franssen MT
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- Adult, Blood Pressure, Creatinine analysis, Female, Gestational Age, Humans, L-Lactate Dehydrogenase analysis, Maternal Age, Multivariate Analysis, Netherlands epidemiology, Platelet Count, Pregnancy, Proteinuria epidemiology, Randomized Controlled Trials as Topic, Risk Assessment, Young Adult, Disease Progression, Hypertension, Pregnancy-Induced epidemiology, Models, Statistical
- Abstract
Introduction: If hypertensive disorders of pregnancy are diagnosed before term, the benefits of immediate delivery need to be weighed against the neonatal consequences of preterm delivery. If we are able to predict which women are at high risk of progression to severe disease, they could be targeted for delivery and maternal complications might be reduced. In addition, this may prevent unnecessary preterm births in women at low risk., Material and Methods: We developed a prediction model using data from the HYPITAT-II trail, which evaluated immediate delivery vs. expectant monitoring in women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation. Univariate and multivariate logistic regression analysis were used to identify relevant variables from clinical and laboratory parameters. The performance of the resulting prediction model was assessed by receiver operating characteristic analysis, calibration and bootstrapping, using the average predicted probabilities., Results: We included 519 women, 115 (22.2%) of whom developed severe hypertensive disorders of pregnancy. The prediction model included: maternal age (odds ratio 0.92 per year), gestational age (odds ratio 0.87 per week), systolic blood pressure (odds ratio 1.05 per mmHg), the presence of chronic hypertension (odds ratio 2.4), platelet count (odds ratio 0.996), creatinine (odds ratio 1.02) and lactate dehydrogenase (odds ratio 1.003). The model showed good fit (p = 0.64), fair discrimination (area under the curve 0.76, 95% confidence interval 0.73-0.81, p < 0.001) and could stratify women in three risk groups of average, intermediate and high risk (predicted probabilities <0.22, <0.44 and >0.45, respectively)., Conclusion: In women with non-severe hypertension in pregnancy near term, progression to severe disease can be predicted. This model requires external validation before it can be applied in practice., (© 2016 Nordic Federation of Societies of Obstetrics and Gynecology.)
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- 2017
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13. The predictive value of quantitative fibronectin testing in combination with cervical length measurement in symptomatic women.
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Bruijn MM, Kamphuis EI, Hoesli IM, Martinez de Tejada B, Loccufier AR, Kühnert M, Helmer H, Franz M, Porath MM, Oudijk MA, Jacquemyn Y, Schulzke SM, Vetter G, Hoste G, Vis JY, Kok M, Mol BW, and van Baaren GJ
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- Adult, Cost-Benefit Analysis, Europe epidemiology, Female, Humans, Logistic Models, Obstetric Labor, Premature diagnostic imaging, Obstetric Labor, Premature metabolism, Predictive Value of Tests, Pregnancy, Premature Birth diagnostic imaging, Premature Birth metabolism, Prospective Studies, Risk Assessment, Vagina chemistry, Young Adult, Cervical Length Measurement, Fibronectins metabolism, Premature Birth epidemiology
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Background: The combination of the qualitative fetal fibronectin test and cervical length measurement has a high negative predictive value for preterm birth within 7 days; however, positive prediction is poor. A new bedside quantitative fetal fibronectin test showed potential additional value over the conventional qualitative test, but there is limited evidence on the combination with cervical length measurement., Objective: The purpose of this study was to compare quantitative fetal fibronectin and qualitative fetal fibronectin testing in the prediction of spontaneous preterm birth within 7 days in symptomatic women who undergo cervical length measurement., Study Design: We performed a European multicenter cohort study in 10 perinatal centers in 5 countries. Women between 24 and 34 weeks of gestation with signs of active labor and intact membranes underwent quantitative fibronectin testing and cervical length measurement. We assessed the risk of preterm birth within 7 days in predefined strata based on fibronectin concentration and cervical length., Results: Of 455 women who were included in the study, 48 women (11%) delivered within 7 days. A combination of cervical length and qualitative fibronectin resulted in the identification of 246 women who were at low risk: 164 women with a cervix between 15 and 30 mm and a negative fibronectin test (<50 ng/mL; preterm birth rate, 2%) and 82 women with a cervix at >30 mm (preterm birth rate, 2%). Use of quantitative fibronectin alone resulted in a predicted risk of preterm birth within 7 days that ranged from 2% in the group with the lowest fibronectin level (<10 ng/mL) to 38% in the group with the highest fibronectin level (>500 ng/mL), with similar accuracy as that of the combination of cervical length and qualitative fibronectin. Combining cervical length and quantitative fibronectin resulted in the identification of an additional 19 women at low risk (preterm birth rate, 5%), using a threshold of 10 ng/mL in women with a cervix at <15 mm, and 6 women at high risk (preterm birth rate, 33%) using a threshold of >500 ng/mL in women with a cervix at >30 mm., Conclusion: In women with threatened preterm birth, quantitative fibronectin testing alone performs equal to the combination of cervical length and qualitative fibronectin. Possibly, the combination of quantitative fibronectin testing and cervical length increases this predictive capacity. Cost-effectiveness analysis and the availability of these tests in a local setting should determine the final choice., (Copyright © 2016 Elsevier Inc. All rights reserved.)
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- 2016
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14. Quantitative fetal fibronectin testing in combination with cervical length measurement in the prediction of spontaneous preterm delivery in symptomatic women.
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Bruijn M, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, Oei G, Scheepers H, Spaanderman M, Bloemenkamp K, Haak MC, Bolte AC, Vandenbussche F, Woiski MD, Bax CJ, Cornette J, Duvekot JJ, Nij Bijvanck B, van Eyck J, Franssen M, Sollie KM, van der Post J, Bossuyt P, Opmeer BC, Kok M, Mol B, and van Baaren GJ
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- Cervix Uteri chemistry, Cohort Studies, Female, Humans, Infant, Newborn, Obstetric Labor, Premature, Predictive Value of Tests, Premature Birth, Cervical Length Measurement, Fibronectins
- Abstract
Objective: To evaluate whether in symptomatic women, the combination of quantitative fetal fibronectin (fFN) testing and cervical length (CL) improves the prediction of preterm delivery (PTD) within 7 days compared with qualitative fFN and CL., Design: Post hoc analysis of frozen fFN samples of a nationwide cohort study., Setting: Ten perinatal centres in the Netherlands., Population: Symptomatic women between 24 and 34 weeks of gestation., Methods: The risk of PTD <7 days was estimated in predefined CL and fFN strata. We used logistic regression to develop a model including quantitative fFN and CL, and one including qualitative fFN (threshold 50 ng/ml) and CL. We compared the models' capacity to identify women at low risk (<5%) for delivery within 7 days using a reclassification table., Main Outcome Measures: Spontaneous delivery within 7 days after study entry., Results: We studied 350 women, of whom 69 (20%) delivered within 7 days. The risk of PTD in <7 days ranged from 2% in the lowest fFN group (<10 ng/ml) to 71% in the highest group (>500 ng/ml). Multivariable logistic regression showed an increasing risk of PTD in <7 days with rising fFN concentration [10-49 ng/ml: odds ratio (OR) 1.3, 95% confidence interval (95% CI) 0.23-7.0; 50-199 ng/ml: OR 3.2, 95% CI 0.79-13; 200-499 ng/ml: OR 9.0, 95% CI 2.3-35; >500 ng/ml: OR 39, 95% CI 9.4-164] and shortening of the CL (OR 0.86 per mm, 95% CI 0.82-0.90). Use of quantitative fFN instead of qualitative fFN resulted in reclassification of 18 (5%) women from high to low risk, of whom one (6%) woman delivered within 7 days., Conclusion: In symptomatic women, quantitative fFN testing does not improve the prediction of PTD within 7 days compared with qualitative fFN testing in combination with CL measurement in terms of reclassification from high to low (<5%) risk, but it adds value across the risk range., Tweetable Abstract: Quantitative fFN testing adds value to qualitative fFN testing with CL measurement in the prediction of PTD., (© 2015 Royal College of Obstetricians and Gynaecologists.)
- Published
- 2016
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15. The impact of fetal gender and ethnicity on the risk of spontaneous preterm delivery in women with symptoms of preterm labor.
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Wilms FF, Vis JY, Oudijk MA, Kwee A, Porath MM, Scheepers HC, Spaanderman ME, Bloemenkamp KW, Bolte AC, Bax CJ, Cornette JM, Duvekot JJ, Nij Bijvanck BW, Eijck Jv, Franssen MT, Sollie KM, Vandenbussche FP, Woiski MD, van der Post JA, Bossuyt PM, Opmeer BC, Mol BW, and van Baaren GJ
- Subjects
- Adult, Cervical Length Measurement statistics & numerical data, Chi-Square Distribution, Female, Fetal Development, Fibronectins analysis, Gestational Age, Humans, Male, Pregnancy, Prospective Studies, Risk, Sex Distribution, White People ethnology, Obstetric Labor, Premature ethnology, Premature Birth ethnology, Sex Factors
- Abstract
Objective: The objective of this study is to evaluate the relation among fetal gender, ethnicity, and preterm labor (PTL) and preterm delivery (PTD)., Methods: A secondary analysis was performed of a prospective cohort study including women with symptoms of PTL between 24 and 34 weeks. The proportion of women carrying a male or female fetus at the onset of PTL was calculated. Gestational age at delivery and risk of PTD of both fetal genders was compared and interaction of fetal gender and maternal ethnicity on the risk of PTD was evaluated., Results: Of the 594 included women, 327 (55%) carried a male fetus. Median gestational age at delivery in women pregnant with a male fetus was 37 5/7 (IQR 34 4/7-39 1/7) weeks compared with 38 1/7 (IQR 36 0/7-39 5/7) weeks in women pregnant with a female fetus (p = 0.032). The risk of PTD did not differ significantly. In Caucasians, we did find an increased risk of PTD before 37 weeks in women pregnant with a male fetus (OR 1.9 (95% CI 1.2-3.0))., Conclusions: The majority of women with PTL are pregnant with a male fetus and these women deliver slightly earlier. Race seems to affect this disparity.
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- 2016
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16. Comparison of the Actim Partus test and the fetal fibronectin test in the prediction of spontaneous preterm birth in symptomatic women undergoing cervical length measurement.
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Bruijn MM, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, Oei G, Scheepers HC, Spaanderman ME, Bloemenkamp KW, Haak MC, Bolte AC, Vandenbussche FP, Woiski MD, Bax CJ, Cornette JM, Duvekot JJ, Nij Bijvank BW, van Eyck J, Franssen MT, Sollie KM, van der Post JA, Bossuyt PM, Opmeer BC, Kok M, Mol BW, and van Baaren GJ
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- Adult, Female, Humans, Infant, Newborn, Predictive Value of Tests, Pregnancy, Sensitivity and Specificity, Cervical Length Measurement, Cervix Uteri, Fibronectins analysis, Obstetric Labor, Premature diagnosis, Premature Birth diagnosis
- Abstract
Objective: To compare the accuracy of the Actim Partus test and fetal fibronectin (fFN) test in the prediction of spontaneous preterm delivery within seven days in symptomatic women undergoing cervical length measurement., Study Design: We performed a post-hoc analysis on frozen samples of a nationwide cohort study in all 10 perinatal centres in the Netherlands. We selected samples from women with signs of preterm labour between 24 and 34 weeks of gestational age and a cervical length below 30mm. Delivery within seven days after initial assessment was the primary endpoint. We calculated sensitivity, specificity, and positive and negative predictive values for the combination of both the Actim Partus test and fFN test with cervical length. A test was considered positive in case of a cervical length between 15 and 30mm with a positive Actim Partus or fFN test, and a cervical length below 15mm regardless the test result., Results: In total, samples of 350 women were tested, of whom 69 (20%) delivered within seven days. Eighty-four women had a positive Actim Partus test and 162 women a positive fFN test, of whom 54 (64%) and 63 (39%) delivered within seven days, respectively. Ninety-seven women had a cervical length below 15mm, of whom 50 (52%) delivered within seven days. Sensitivity, specificity, positive and negative predictive values of combining cervical length with the Actim Partus test or the fFN test were 91%, 75%, 47% and 97%, and 96%, 58%, 36% and 98%, respectively., Conclusion: According to this post-hoc study, in combination with cervical length, the Actim Partus test could be used as an alternative for the fFN test to identify women who will not deliver within seven days after presentation. Further evidence should be collected in a prospective comparative study., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
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- 2016
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17. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial.
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Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, and Bloemenkamp KW
- Subjects
- Administration, Oral, Adult, Apgar Score, Asphyxia Neonatorum etiology, Catheterization adverse effects, Cervical Ripening drug effects, Delivery, Obstetric methods, Drug Administration Schedule, Female, Humans, Infant, Newborn, Labor, Induced adverse effects, Misoprostol adverse effects, Oxytocics adverse effects, Postpartum Hemorrhage etiology, Pregnancy, Term Birth, Urinary Catheterization instrumentation, Catheterization methods, Labor, Induced methods, Misoprostol administration & dosage, Oxytocics administration & dosage
- Abstract
Background: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone., Methods: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466., Findings: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure., Interpretation: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness., Funding: FondsNutsOhra., (Copyright © 2016 Elsevier Ltd. All rights reserved.)
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- 2016
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18. Prescribing patterns of antenatal corticosteroids in women with threatened preterm labor.
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Wilms FF, van Baaren GJ, Vis JY, Oudijk MA, Kwee A, Porath MM, Scheepers HC, Spaanderman ME, Bloemenkamp KW, Bolte AC, Bax CJ, Cornette JM, Duvekot JJ, Nij Bijvank BW, van Eyck J, Franssen MT, Sollie KM, Vandenbussche FP, Woiski MD, van der Post JA, Bossuyt PM, Opmeer BC, and Mol BW
- Subjects
- Adult, Drug Prescriptions, Female, Gestational Age, Humans, Pregnancy, Prenatal Care, Prospective Studies, Time Factors, Young Adult, Adrenal Cortex Hormones therapeutic use, Cervical Length Measurement, Fibronectins analysis, Obstetric Labor, Premature drug therapy, Practice Patterns, Physicians', Premature Birth drug therapy
- Abstract
Objective: To assess the impact of cervical length (CL) measurement and fetal fibronectin testing (fFN) on the clinicians' decision to prescribe antenatal corticosteroids (ACS) to women with symptoms of preterm labor., Study Design: This is a secondary analysis of a prospective cohort study including women with symptoms of preterm labor and intact membranes between 24 and 34 weeks' gestation. We compared the proportion prescribed and completed ACS courses, preterm delivery within seven days and median intervals from ACS to delivery in four groups: group 1 CL<10 mm, group 2 CL 10-30 mm and positive fFN, group 3 CL 10-30 mm and negative fFN, group 4 CL>30 mm., Results: ACS were prescribed to 63/65 (97%) women in group 1, 176/192 (91%) in group 2, 111/172 women (65%) in group 3 and 55/242 (23%) in group 4. In group 1, 42 (65%) women delivered within seven days, compared to 34 (18%) in group 2, 6 (3%) in group 3 and 3 (1%) in group 4. Median intervals between ACS and delivery were 6 days (IQR 3-61 days), 44 days (IQR 17-69 days), 53 days (IQR 37-77 days) and 66 days (IQR 43-78 days) in group 1, 2, 3 and 4 respectively., Conclusion: ACS were prescribed frequently to women with a CL of 10-30 mm and a negative fFN test or a CL>30 mm. There is room for improvement in the prescription of ACS in these low risk women., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)
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- 2015
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19. Risk factors for preterm delivery: do they add to fetal fibronectin testing and cervical length measurement in the prediction of preterm delivery in symptomatic women?
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van Baaren GJ, Bruijn MM, Vis JY, Wilms FF, Oudijk MA, Kwee A, Porath MM, Oei G, Scheepers HC, Spaanderman ME, Bloemenkamp KW, Haak MC, Bolte AC, Bax CJ, Cornette JM, Duvekot JJ, Nij Bijvanck BW, van Eijck J, Franssen MT, Sollie KM, Vandenbussche FP, Woiski M, Bossuyt PM, Opmeer BC, and Mol BW
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- Adult, Area Under Curve, C-Reactive Protein metabolism, Delivery, Obstetric, Female, Gestational Age, Humans, Labor Stage, First physiology, Logistic Models, Maternal Age, Multivariate Analysis, Netherlands epidemiology, Parity, Predictive Value of Tests, Pregnancy, Prospective Studies, ROC Curve, Recurrence, Risk Assessment methods, Risk Assessment statistics & numerical data, Risk Factors, Symptom Assessment, Time Factors, Uterine Hemorrhage epidemiology, Young Adult, Cervical Length Measurement, Fibronectins analysis, Premature Birth epidemiology
- Abstract
Objective: To assess whether patient characteristics add to the fetal fibronectin test and cervical length measurement in the prediction of preterm delivery in symptomatic women., Study Design: A nationwide prospective cohort study was conducted in all ten perinatal centres in the Netherlands. Women with symptoms of preterm labour between 24 and 34 weeks gestation with intact membranes were invited. In all women qualitative fibronectin testing (0.050 μg/mL cut-off) and cervical length measurement were performed. Only singleton pregnancies were included in this analysis. Logistic regression was used to construct two multivariable models to predict spontaneously delivery within 7 days: a model including cervical length and fetal fibronectin as predictors, and an extended model including all potential predictors. The models were internally validated using bootstrapping techniques. Predictive performances were assessed as the area under the receiver operator characteristic curve (AUC) and calibration plots. We compared the models' capability to identify women with a low risk to deliver within 7 days. A risk less than 5%, corresponding to the risk for women with a cervical length of at least 25 mm, was considered as low risk., Results: Seventy-three of 600 included women (12%) had delivered spontaneously within 7 days. The extended model included maternal age, parity, previous preterm delivery, vaginal bleeding, C-reactive protein, cervical length, dilatation and fibronectin status. Both models had high discriminative performances (AUC of 0.92 (95% CI 0.88-0.95) and 0.95 (95% CI 0.92-0.97) respectively). Compared to the model with fibronectin and cervical length, our extended model reclassified 38 women (6%) from low risk to high risk and 21 women (4%) from high risk to low risk. Preterm delivery within 7 days occurred once in both the reclassification groups., Conclusion: In women with symptoms of preterm labour before 34 weeks gestation, a model that integrates maternal characteristics, clinical signs and laboratory tests, did not predict delivery within 7 days better than a model with only fibronectin and cervical length., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)
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- 2015
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20. Relevance of individual participant data meta-analysis for studies in obstetrics: delivery versus expectant monitoring for hypertensive disorders of pregnancy.
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Broekhuijsen K, Bernardes T, van Baaren GJ, Tajik P, Novikova N, Thangaratinam S, Boers K, Koopmans CM, Wallace K, Shennan AH, Langenveld J, Groen H, van den Berg PP, Mol BW, and Franssen MT
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- Adult, Cesarean Section adverse effects, Disease Progression, Female, Humans, Hypertension, Pregnancy-Induced mortality, Hypertension, Pregnancy-Induced physiopathology, Infant, Newborn, Male, Pregnancy, Pregnancy Trimester, Third, Premature Birth epidemiology, Premature Birth mortality, Premature Birth prevention & control, Risk, Severity of Illness Index, Hypertension, Pregnancy-Induced therapy, Labor, Induced adverse effects, Precision Medicine, Watchful Waiting
- Abstract
Like many other research subjects in obstetrics, research on immediate delivery versus expectant monitoring for women with hypertensive disorders of pregnancy faces certain challenges when it comes to interpretation and generalisation of the results; relatively rare outcomes are studied, in a clinically heterogeneous population, while the clinical practice in some countries has dictated that studies in term pregnancy were completed before earlier gestational ages could be studied. This has resulted in multiple smaller studies, some studying surrogate outcome measures, with different in- and exclusion criteria, and without enough power for reliable subgroup analyses. All this complicates the generation of definitive answers and implementation of the results into clinical practice. Performing multiple studies and subsequently pooling their results in a meta-analysis can be a way to overcome the difficulties of studying relatively rare outcomes and subgroups with enough power, as well as a solution to reach a final answer on questions involving an uncertain and possibly harmful intervention. However, in the case of the current studies on delivery versus expectant monitoring in women with hypertensive disorders of pregnancy, differences regarding eligibility criteria, outcome measures and subgroup definitions make it difficult to pool their results in an aggregate meta-analysis. Individual patient data meta-analysis (IPDMA) has the potential to overcome these challenges, because it allows for flexibility regarding the choice of endpoints and standardisation of inclusion and exclusion criteria across studies. In addition, it has more statistical power for informative subgroup analyses. We therefore propose an IPDMA on immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy, and advocate the use of IPDMA for research questions in obstetrics that face similar challenges., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)
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- 2015
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21. Risk stratification with cervical length and fetal fibronectin in women with threatened preterm labor before 34 weeks and not delivering within 7 days.
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Hermans FJR, Bruijn MMC, Vis JY, Wilms FF, Oudijk MA, Porath MM, Scheepers HCJ, Bloemenkamp KWM, Bax CJ, Cornette JMJ, Nij Bijvanck BWA, Franssen MTM, Vandenbussche FPHA, Kok M, Grobman WA, Van Der Post JAM, Bossuyt PMM, Opmeer BC, Mol BWJ, Schuit E, and Van Baaren GJ
- Subjects
- Adult, Female, Humans, Netherlands epidemiology, Obstetric Labor, Premature blood, Pregnancy, Premature Birth epidemiology, Proportional Hazards Models, Prospective Studies, Term Birth, Cervical Length Measurement, Fibronectins blood, Obstetric Labor, Premature epidemiology, Risk Assessment
- Abstract
Objective: To stratify the risk of spontaneous preterm delivery using cervical length (CL) and fetal fibronectin (fFN) in women with threatened preterm labor who remained pregnant after 7 days., Design: Prospective observational study., Setting: Nationwide cohort of women with threatened preterm labor from the Netherlands., Population: Women with threatened preterm labor between 24 and 34 weeks with a valid CL and fFN measurement and remaining pregnant 7 days after admission., Methods: Kaplan-Meier and Cox proportional hazards models were used to estimate cumulative percentages and hazard ratios (HR) for spontaneous delivery., Main Outcome Measures: Spontaneous delivery between 7 and 14 days after initial presentation and spontaneous preterm delivery before 34 weeks., Results: The risk of delivery between 7 and 14 days was significantly increased for women with a CL < 15 mm or a CL ≥15 to <30 mm and a positive fFN, compared with women with a CL ≥30 mm: HR 22.3 [95% confidence interval (CI) 2.6-191] and 14 (95% CI 1.8-118), respectively. For spontaneous preterm delivery before 34 weeks the risk was increased for women with a CL < 15 mm [HR 6.3 (95% CI 2.6-15)] or with a CL ≥15 to <30 mm with either positive fFN [HR 3.6 (95% CI 1.5-8.7)] or negative fFN [HR 3.0 (95% CI 1.2-7.1)] compared with women with a CL ≥ 30 mm., Conclusions: In women remaining pregnant 7 days after threatened preterm labor, CL and fFN results can be used in risk stratification for spontaneous delivery., (© 2015 Nordic Federation of Societies of Obstetrics and Gynecology.)
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- 2015
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22. Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial.
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Broekhuijsen K, van Baaren GJ, van Pampus MG, Ganzevoort W, Sikkema JM, Woiski MD, Oudijk MA, Bloemenkamp KW, Scheepers HC, Bremer HA, Rijnders RJ, van Loon AJ, Perquin DA, Sporken JM, Papatsonis DN, van Huizen ME, Vredevoogd CB, Brons JT, Kaplan M, van Kaam AH, Groen H, Porath MM, van den Berg PP, Mol BW, Franssen MT, and Langenveld J
- Subjects
- Adult, Female, Humans, Hypertension diagnosis, Hypertension, Pregnancy-Induced diagnosis, Infant, Newborn, Monitoring, Physiologic, Pre-Eclampsia diagnosis, Pregnancy, Pregnancy Complications, Cardiovascular diagnosis, Pregnancy Trimester, Third, Risk Factors, Cesarean Section, Hypertension therapy, Hypertension, Pregnancy-Induced therapy, Labor, Induced, Pre-Eclampsia therapy, Pregnancy Complications, Cardiovascular therapy, Pregnancy Outcome
- Abstract
Background: There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy. We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women., Methods: We did an open-label, randomised controlled trial, in seven academic hospitals and 44 non-academic hospitals in the Netherlands. Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h (immediate delivery) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation (expectant monitoring). The primary outcomes were a composite of adverse maternal outcomes (thromboembolic disease, pulmonary oedema, eclampsia, HELLP syndrome, placental abruption, or maternal death), and neonatal respiratory distress syndrome, both analysed by intention-to-treat. This study is registered with the Netherlands Trial Register (NTR1792)., Findings: Between March 1, 2009, and Feb 21, 2013, 897 women were invited to participate, of whom 703 were enrolled and randomly assigned to immediate delivery (n=352) or expectant monitoring (n=351). The composite adverse maternal outcome occurred in four (1·1%) of 352 women allocated to immediate delivery versus 11 (3·1%) of 351 women allocated to expectant monitoring (relative risk [RR] 0·36, 95% CI 0·12-1·11; p=0·069). Respiratory distress syndrome was diagnosed in 20 (5·7%) of 352 neonates in the immediate delivery group versus six (1·7%) of 351 neonates in the expectant monitoring group (RR 3·3, 95% CI 1·4-8·2; p=0·005). No maternal or perinatal deaths occurred., Interpretation: For women with non-severe hypertensive disorders at 34-37 weeks of gestation, immediate delivery might reduce the already small risk of adverse maternal outcomes. However, it significantly increases the risk of neonatal respiratory distress syndrome, therefore, routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered., Funding: ZonMw., (Copyright © 2015 Elsevier Ltd. All rights reserved.)
- Published
- 2015
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23. Randomized comparison of nifedipine and placebo in fibronectin-negative women with symptoms of preterm labor and a short cervix (APOSTEL-I Trial).
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Vis JY, van Baaren GJ, Wilms FF, Oudijk MA, Kwee A, Porath MM, Scheepers HC, Spaanderman ME, Bloemenkamp KW, van Lith JM, Bolte AC, Bax CJ, Cornette J, Duvekot JJ, Nij Bijvank SW, van Eyck J, Franssen MT, Sollie KM, Woiski M, Vandenbussche FP, van der Post JA, Bossuyt PM, Opmeer BC, and Mol BW
- Subjects
- Adult, Female, Gestational Age, Humans, Netherlands, Obstetric Labor, Premature prevention & control, Pregnancy, Pregnancy Complications prevention & control, Treatment Outcome, Young Adult, Cervical Length Measurement, Fibronectins analysis, Nifedipine therapeutic use, Obstetric Labor, Premature drug therapy, Pregnancy Complications drug therapy, Tocolytic Agents therapeutic use
- Abstract
Objective: To evaluate whether tocolysis with nifedipine can be omitted in women with symptoms of preterm labor, a shortened cervix, and negative fetal fibronectin test., Study Design: A randomized noninferiority trial was performed in all Dutch perinatal centers. Women with symptoms of preterm labor between 24 and 34 weeks, intact membranes, cervical length between 10 and 30 mm, and negative fibronectin test were randomly allocated to nifedipine (80 mg/day) or placebo. The primary outcome was delivery within 7 days. Secondary outcomes were severe neonatal morbidity and mortality. We also followed all eligible nonrandomized women., Results: We allocated 37 women to nifedipine and 36 women to placebo. In the nifedipine group, three women (8.1%) delivered within 7 days, compared with one woman (2.8%) in the placebo group (difference -5.3%; one-sided 95% confidence limit 4.5%). Median gestational age at delivery were respectively 37 + 0 (interquartile range [IQR] 34 + 6 to 38 + 5) and 38 + 2 (IQR 37 + 0 to 39 + 6) weeks (p = 0.008). In the nifedipine group, three pregnancies (8.1%) had a poor outcome; there were no poor outcomes in the placebo group. We observed similar trends in eligible nonrandomized women., Conclusion: In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
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- 2015
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24. Preterm birth in singleton and multiple pregnancies: evaluation of costs and perinatal outcomes.
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van Baaren GJ, Peelen MJ, Schuit E, van der Post JA, Mol BW, Kok M, and Hajenius PJ
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- Chronic Disease, Costs and Cost Analysis, Direct Service Costs statistics & numerical data, Enterocolitis, Necrotizing epidemiology, Female, Humans, Infant, Newborn, Infant, Premature, Intracranial Hemorrhages epidemiology, Leukomalacia, Periventricular epidemiology, Lung Diseases epidemiology, Netherlands epidemiology, Perinatal Mortality, Pregnancy, Premature Birth mortality, Prospective Studies, Randomized Controlled Trials as Topic, Sepsis epidemiology, Gestational Age, Infant, Newborn, Diseases epidemiology, Pregnancy, Multiple, Premature Birth economics
- Abstract
Objective: To estimate costs of preterm birth in singleton and multiple pregnancies., Study Design: Cost analysis based on data from a prospective cohort study and three multicentre randomised controlled trials (2006-2012) in a Dutch nationwide consortium for women's health research. Women with preterm birth before 37 completed weeks were included for analysis. Direct costs were estimated from a health care perspective, from delivery until discharge or decease of the neonates. Costs and adverse perinatal outcome per pregnancy were measured. Adverse perinatal outcome comprised both perinatal mortality and a composite of neonatal morbidity defined as chronic lung disease, intraventricular haemorrhage≥grade 2, periventricular leukomalacia≥grade 1, proven sepsis or necrotising enterocolitis. Using a moving average technique covering three weeks per measurement, costs and adverse perinatal outcome per woman delivering for every week between 24 and 37 weeks are reported., Results: Data of 2802 women were available of whom 1503 (53.6%) had a preterm birth; 501 in 1090 singleton (46%) and 1002 in 1712 multiple pregnancies (58.5%). The most frequent perinatal outcomes were perinatal mortality, chronic lung disease and sepsis. For singleton pregnancies the peak of total costs was at 25 weeks (€88,052 per delivery), compared to 27 weeks for multiple pregnancies (€169,571 per delivery). The total costs declined rapidly with increasing duration of pregnancy. Major cost drivers were length of stay on the NICU and airway treatments. The peaks seen in costs paralleled with the prevalence of adverse perinatal outcome., Conclusions: These data can be used to elaborate on the impact of preterm birth in case only data are available on duration of pregnancy., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2015
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