Background In women with unexplained infertility, tubal flushing with oil-based contrast during h... more Background In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography (HSG) increases ongoing pregnancy and subsequent live birth rates when compared to tubal flushing with water-based contrast. It is currently unclear whether an HSG with oil-based contrast also results in more ongoing pregnancies and live births in women of advanced age, women with ovulation disorders, and women with potential tubal pathology when compared to an HSG with water-based contrast. Methods We plan an international, multicentre, open-label, randomized controlled trial (RCT) studying three groups of infertile women who have an indication for tubal patency testing according to their treating physician and additionally; (1) are 39 years of age or older, (2) have an ovulation disorder or (3) have a high risk for tubal pathology based on their medical history. Women with an allergy for iodinated contrast medium are excluded, as are women with diabetes, hyperprola...
Disclaimer/Complaints regulations If you believe that digital publication of certain material inf... more Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.
Disclaimer/Complaints regulations If you believe that digital publication of certain material inf... more Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.
STUDY QUESTION Does assisted reproduction, such as ovarian stimulation and/or laboratory procedur... more STUDY QUESTION Does assisted reproduction, such as ovarian stimulation and/or laboratory procedures, have impact on perinatal outcomes of singleton live births compared to natural conception in couples with unexplained subfertility? SUMMARY ANSWER Compared to natural conception, singletons born after intrauterine insemination with ovarian stimulation (IUI-OS) had a lower birthweight, while singletons born after IVF had comparable birthweights, in couples with unexplained subfertility. WHAT IS KNOWN ALREADY Singletons conceived by assisted reproduction have different perinatal outcomes such as low birthweight and a higher risk of premature birth than naturally conceived singletons. This might be due to the assisted reproduction, such as laboratory procedures or the ovarian stimulation, or to an intrinsic factor in couples with subfertility. STUDY DESIGN, SIZE, DURATION We performed a prospective cohort study using the follow-up data of two randomized clinical trials performed in coup...
Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology, Jan 31, 2017
To evaluate the cost-effectiveness of combining cervical length (CL) measurement and fetal fibron... more To evaluate the cost-effectiveness of combining cervical length (CL) measurement and fetal fibronectin (fFN) tests for women with symptoms of preterm labor between 24 and 34 weeks gestation. We performed a model-based cost-effectiveness analysis to evaluate seven test-treatment strategies based on CL and/or fFN in women with symptoms of preterm labor from a societal perspective, in which we weighted neonatal outcome and costs. Estimates of disease prevalence, test accuracy and costs, were based on two recently performed nationwide cohort studies in The Netherlands. FFN testing and CL measurement as single tests to predict preterm delivery result in more costs and more adverse neonatal outcomes than strategies that combine both tests. Additional fFN testing in case of a CL between 15-30 mm was considered cost-effective; compared to a treat all strategy it led to a cost saving of €3919 per woman with a small deterioration in neonatal health outcomes; 1 additional perinatal death and 2...
Is pre-ovulatory endometrial thickness (EMT) in women with unexplained subfertility undergoing IU... more Is pre-ovulatory endometrial thickness (EMT) in women with unexplained subfertility undergoing IUI with ovarian stimulation (OS) associated with pregnancy chances? We found no evidence for an association between EMT and pregnancy chances. It has been suggested that OS with clomiphene citrate (CC) results in a lower EMT than with gonadotrophins or aromatase inhibitors, but the clinical consequences in terms of pregnancy are unclear. We performed a systematic review and meta-analysis of studies comparing CC, gonadotrophins or aromatase inhibitors in an IUI program reporting on EMT and pregnancy rates in women with unexplained subfertility. We searched MEDLINE, EMBASE and the non-MEDLINE subset of PubMed from inception to 28th June 2016 and cross-checked references of relevant articles. Outcome measures were clinical pregnancy rate and mean pre-ovulatory EMT. We calculated mean differences (MD) with 95% CIs with a fixed effect model, and in case of heterogeneity with an I2 > 50% a r...
BJOG : an international journal of obstetrics and gynaecology, Jan 19, 2016
To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using ... more To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation. Multicentre, open-label, randomised controlled trial. Eighteen hospitals in the Netherlands and one hospital in England. Women with a symptomatic cyst or abscess of the Bartholin gland. Women were randomised to treatment with Word catheter or marsupialisation. The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2). One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline ch...
Vasa previa is an obstetric complication in which the fetal blood vessels lie outside the chorion... more Vasa previa is an obstetric complication in which the fetal blood vessels lie outside the chorionic plate in close proximity to the internal cervical os. In women with vasa previa, the risk of rupture of these vessels is increased, thus potentially causing fetal death or serious morbidity. Our objective was to assess the accuracy of ultrasound in the prenatal diagnosis of vasa previa. We searched MEDLINE, EMBASE, the Cochrane Library and PubMed for studies on vasa previa. Two reviewers independently selected studies on the accuracy of ultrasound in the diagnosis of vasa previa. The studies were scored on methodological quality using the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2). Data on sensitivity and specificity were subsequently extracted. The literature search revealed 583 articles, of which two prospective and six retrospective cohort studies were eligible for inclusion in the qualitative analysis. All studies documented methods suitable for the prenatal diagnosis of vasa previa. Four out of the eight studies used transvaginal ultrasound (TVS) for primary evaluation, while the remaining four studies used transabdominal ultrasound and performed a subsequent TVS when vasa previa was suspected. The QUADAS-2 tool reflected poor methodology in six of the eight included studies, and prenatal detection rates varied from 53% (10/19) to 100% (total of 442,633 patients, including 138 cases of vasa previa). In the two prospective studies (n = 33,795, including 11 cases of vasa previa), transvaginal color Doppler performed during the second trimester detected all cases of vasa previa (sensitivity, 100%) with a specificity of 99.0-99.8%. The accuracy of ultrasound in the diagnosis of vasa previa is high when performed transvaginally in combination with color Doppler.
What are the pregnancy outcomes for women with a twin pregnancy that is reduced to a singleton pr... more What are the pregnancy outcomes for women with a twin pregnancy that is reduced to a singleton pregnancy? Fetal reduction of a twin pregnancy significantly improves gestational age at birth and neonatal birthweight, however at an increased risk of pregnancy loss and preterm delivery. Women with a multiple pregnancy are at increased risk for preterm delivery. Fetal reduction can be considered in these women. Retrospective cohort study of 118 women with a twin pregnancy reduced to a singleton pregnancy between 2000 and 2010. We compared the outcome of pregnancy in consecutive women with a dichorionic twin pregnancy that was reduced to a singleton pregnancy to that of women with a dichorionic twin pregnancy that was managed expectantly and women with a primary singleton pregnancy. Reductions were performed between 10-23(6/7) weeks' gestation by intracardiac or intrathoracic injection of potassium chloride, mostly for congenital anomalies. We compared median gestational age, pregnan...
Objective Assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in wome... more Objective Assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in women with a multiple pregnancy.Study designAn economic analysis alongside a randomized clinical trial evaluating cervical pessaries (ProTWIN).Women with a multiple pregnancy were included. We performed an economic evaluation from a societal perspective. Costs were estimated between randomisation and 6 weeks postpartum. We separately analysed the prespecified subgroup of women with a cervical length (CL) below the 25th percentile (<38 mm).Primary endpoint was poor perinatal outcome until 6 weeks postpartum. We estimated direct medical costs and health outcomes. We calculated incremental cost-effectiveness ratios for costs to prevent one poor outcome.ResultsMean costs in the pessary group (n = 401) were €21884 versus €22030 in the no-pessary group (n = 407) (difference -€146 (95% confidence interval (CI) €-5648 to €4718)). In the prespecified subgroup of women with a CL <38 mm we demons...
To assess adherence to expectant management of 6-12 months in couples with unexplained subfertili... more To assess adherence to expectant management of 6-12 months in couples with unexplained subfertility, as recommended by the Dutch Networkguideline Subfertility. A retrospective cohort study in 25 clinics. Couples were eligible to participate if they were diagnosed with unexplained subfertility and had a good prognosis of natural conception within one year (>30%), for these couples the networkguideline recommends an expectant management. Outcomes measures are overtreatment, i.e. couples that started treatment within six months, and three quality indicators: 1) prognosis not calculated, 2) no correct expectant management advised, 3) starting treatment too soon despite a correct advise. Data collection was obtained from medical records. Multilevel regression analyses were performed to investigate associations of overtreatment with patient and clinic characteristics. We included 544 couples. Overtreatment occurred in 36% (N=198). In 34% (N=186) of all couples no prognosis was calculat...
Background In women with unexplained infertility, tubal flushing with oil-based contrast during h... more Background In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography (HSG) increases ongoing pregnancy and subsequent live birth rates when compared to tubal flushing with water-based contrast. It is currently unclear whether an HSG with oil-based contrast also results in more ongoing pregnancies and live births in women of advanced age, women with ovulation disorders, and women with potential tubal pathology when compared to an HSG with water-based contrast. Methods We plan an international, multicentre, open-label, randomized controlled trial (RCT) studying three groups of infertile women who have an indication for tubal patency testing according to their treating physician and additionally; (1) are 39 years of age or older, (2) have an ovulation disorder or (3) have a high risk for tubal pathology based on their medical history. Women with an allergy for iodinated contrast medium are excluded, as are women with diabetes, hyperprola...
Disclaimer/Complaints regulations If you believe that digital publication of certain material inf... more Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.
Disclaimer/Complaints regulations If you believe that digital publication of certain material inf... more Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.
STUDY QUESTION Does assisted reproduction, such as ovarian stimulation and/or laboratory procedur... more STUDY QUESTION Does assisted reproduction, such as ovarian stimulation and/or laboratory procedures, have impact on perinatal outcomes of singleton live births compared to natural conception in couples with unexplained subfertility? SUMMARY ANSWER Compared to natural conception, singletons born after intrauterine insemination with ovarian stimulation (IUI-OS) had a lower birthweight, while singletons born after IVF had comparable birthweights, in couples with unexplained subfertility. WHAT IS KNOWN ALREADY Singletons conceived by assisted reproduction have different perinatal outcomes such as low birthweight and a higher risk of premature birth than naturally conceived singletons. This might be due to the assisted reproduction, such as laboratory procedures or the ovarian stimulation, or to an intrinsic factor in couples with subfertility. STUDY DESIGN, SIZE, DURATION We performed a prospective cohort study using the follow-up data of two randomized clinical trials performed in coup...
Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology, Jan 31, 2017
To evaluate the cost-effectiveness of combining cervical length (CL) measurement and fetal fibron... more To evaluate the cost-effectiveness of combining cervical length (CL) measurement and fetal fibronectin (fFN) tests for women with symptoms of preterm labor between 24 and 34 weeks gestation. We performed a model-based cost-effectiveness analysis to evaluate seven test-treatment strategies based on CL and/or fFN in women with symptoms of preterm labor from a societal perspective, in which we weighted neonatal outcome and costs. Estimates of disease prevalence, test accuracy and costs, were based on two recently performed nationwide cohort studies in The Netherlands. FFN testing and CL measurement as single tests to predict preterm delivery result in more costs and more adverse neonatal outcomes than strategies that combine both tests. Additional fFN testing in case of a CL between 15-30 mm was considered cost-effective; compared to a treat all strategy it led to a cost saving of €3919 per woman with a small deterioration in neonatal health outcomes; 1 additional perinatal death and 2...
Is pre-ovulatory endometrial thickness (EMT) in women with unexplained subfertility undergoing IU... more Is pre-ovulatory endometrial thickness (EMT) in women with unexplained subfertility undergoing IUI with ovarian stimulation (OS) associated with pregnancy chances? We found no evidence for an association between EMT and pregnancy chances. It has been suggested that OS with clomiphene citrate (CC) results in a lower EMT than with gonadotrophins or aromatase inhibitors, but the clinical consequences in terms of pregnancy are unclear. We performed a systematic review and meta-analysis of studies comparing CC, gonadotrophins or aromatase inhibitors in an IUI program reporting on EMT and pregnancy rates in women with unexplained subfertility. We searched MEDLINE, EMBASE and the non-MEDLINE subset of PubMed from inception to 28th June 2016 and cross-checked references of relevant articles. Outcome measures were clinical pregnancy rate and mean pre-ovulatory EMT. We calculated mean differences (MD) with 95% CIs with a fixed effect model, and in case of heterogeneity with an I2 > 50% a r...
BJOG : an international journal of obstetrics and gynaecology, Jan 19, 2016
To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using ... more To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation. Multicentre, open-label, randomised controlled trial. Eighteen hospitals in the Netherlands and one hospital in England. Women with a symptomatic cyst or abscess of the Bartholin gland. Women were randomised to treatment with Word catheter or marsupialisation. The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2). One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline ch...
Vasa previa is an obstetric complication in which the fetal blood vessels lie outside the chorion... more Vasa previa is an obstetric complication in which the fetal blood vessels lie outside the chorionic plate in close proximity to the internal cervical os. In women with vasa previa, the risk of rupture of these vessels is increased, thus potentially causing fetal death or serious morbidity. Our objective was to assess the accuracy of ultrasound in the prenatal diagnosis of vasa previa. We searched MEDLINE, EMBASE, the Cochrane Library and PubMed for studies on vasa previa. Two reviewers independently selected studies on the accuracy of ultrasound in the diagnosis of vasa previa. The studies were scored on methodological quality using the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2). Data on sensitivity and specificity were subsequently extracted. The literature search revealed 583 articles, of which two prospective and six retrospective cohort studies were eligible for inclusion in the qualitative analysis. All studies documented methods suitable for the prenatal diagnosis of vasa previa. Four out of the eight studies used transvaginal ultrasound (TVS) for primary evaluation, while the remaining four studies used transabdominal ultrasound and performed a subsequent TVS when vasa previa was suspected. The QUADAS-2 tool reflected poor methodology in six of the eight included studies, and prenatal detection rates varied from 53% (10/19) to 100% (total of 442,633 patients, including 138 cases of vasa previa). In the two prospective studies (n = 33,795, including 11 cases of vasa previa), transvaginal color Doppler performed during the second trimester detected all cases of vasa previa (sensitivity, 100%) with a specificity of 99.0-99.8%. The accuracy of ultrasound in the diagnosis of vasa previa is high when performed transvaginally in combination with color Doppler.
What are the pregnancy outcomes for women with a twin pregnancy that is reduced to a singleton pr... more What are the pregnancy outcomes for women with a twin pregnancy that is reduced to a singleton pregnancy? Fetal reduction of a twin pregnancy significantly improves gestational age at birth and neonatal birthweight, however at an increased risk of pregnancy loss and preterm delivery. Women with a multiple pregnancy are at increased risk for preterm delivery. Fetal reduction can be considered in these women. Retrospective cohort study of 118 women with a twin pregnancy reduced to a singleton pregnancy between 2000 and 2010. We compared the outcome of pregnancy in consecutive women with a dichorionic twin pregnancy that was reduced to a singleton pregnancy to that of women with a dichorionic twin pregnancy that was managed expectantly and women with a primary singleton pregnancy. Reductions were performed between 10-23(6/7) weeks' gestation by intracardiac or intrathoracic injection of potassium chloride, mostly for congenital anomalies. We compared median gestational age, pregnan...
Objective Assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in wome... more Objective Assess the cost-effectiveness of a cervical pessary to prevent preterm delivery in women with a multiple pregnancy.Study designAn economic analysis alongside a randomized clinical trial evaluating cervical pessaries (ProTWIN).Women with a multiple pregnancy were included. We performed an economic evaluation from a societal perspective. Costs were estimated between randomisation and 6 weeks postpartum. We separately analysed the prespecified subgroup of women with a cervical length (CL) below the 25th percentile (<38 mm).Primary endpoint was poor perinatal outcome until 6 weeks postpartum. We estimated direct medical costs and health outcomes. We calculated incremental cost-effectiveness ratios for costs to prevent one poor outcome.ResultsMean costs in the pessary group (n = 401) were €21884 versus €22030 in the no-pessary group (n = 407) (difference -€146 (95% confidence interval (CI) €-5648 to €4718)). In the prespecified subgroup of women with a CL <38 mm we demons...
To assess adherence to expectant management of 6-12 months in couples with unexplained subfertili... more To assess adherence to expectant management of 6-12 months in couples with unexplained subfertility, as recommended by the Dutch Networkguideline Subfertility. A retrospective cohort study in 25 clinics. Couples were eligible to participate if they were diagnosed with unexplained subfertility and had a good prognosis of natural conception within one year (>30%), for these couples the networkguideline recommends an expectant management. Outcomes measures are overtreatment, i.e. couples that started treatment within six months, and three quality indicators: 1) prognosis not calculated, 2) no correct expectant management advised, 3) starting treatment too soon despite a correct advise. Data collection was obtained from medical records. Multilevel regression analyses were performed to investigate associations of overtreatment with patient and clinic characteristics. We included 544 couples. Overtreatment occurred in 36% (N=198). In 34% (N=186) of all couples no prognosis was calculat...
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