First-trimester prediction of preterm prelabour rupture of membranes incorporating cervical length measurement.

OBJECTIVES: To examine early pregnancy risk factors for preterm prelabour rupture of membranes (PPROM) and develop a predictive model. STUDY DESIGN: Retrospective analysis of a cohort of mixed-risk singleton pregnancies screened in the first and second trimesters in three Danish tertiary fetal medicine centres, including a cervical length measurement at 11-14 weeks, at 19-21 weeks and at 23-24 weeks of gestation. Univariable and multivariable logistic regression analyses were employed to identify predictive maternal characteristics, biochemical and sonographic factors. Receiver operating characteristic (ROC) curve analysis was used to determine predictors for the most accurate model. RESULTS: Of 3477 screened women, 77 (2.2%) had PPROM. Maternal factors predictive of PPROM in univariable analysis were nulliparity (OR 2.0 (95% CI 1.2-3.3)), PAPP-A < 0.5 MoM (OR 2.6 (1.1-6.2)), previous preterm birth (OR 4.2 (1.9-8.9)), previous cervical conization (OR 3.6 (2.0-6.4)) and cervical length ≤ 25 mm on transvaginal imaging (first-trimester OR 15.9 (4.3-59.3)). These factors all remained statistically significant in a multivariable adjusted model with an AUC of 0.72 in the most discriminatory first-trimester model. The detection rate using this model would be approximately 30% at a false-positive rate of 10%. Potential predictors such as bleeding in early pregnancy and pre-existing diabetes mellitus affected very few cases and could not be formally assessed. CONCLUSIONS: Several maternal characteristics, placental biochemical and sonographic features are predictive of PPROM with moderate discrimination. Larger numbers are required to validate this algorithm and additional biomarkers, not currently used for first-trimester screening, may improve model performance.

Fractional CO2 laser treatment of caesarean section scars-A randomized controlled split-scar trial with long term follow-up assessment.

BACKGROUND AND OBJECTIVES: Caesarean section (c-section) scars can be pose functional and cosmetic challenges and ablative fractional laser (AFXL) treatment may offer benefit to patients. We evaluated textural and color changes over time in AFXL-treated versus untreated control scars. MATERIALS AND METHODS: A randomized, controlled, intra-individual split-scar trial with three sessions of AFXL-treatments for mature c-section scars. Settings of AFXL were adjusted to each individual scar. End-points were blinded on-site clinical evaluations at 1, 3, and 6 months follow-up (Patient and Observer Scar Assessment Scale [POSAS] and Vancouver Scar Scale [VSS]), blinded photo-evaluations, reflectance measurements, tissue histology, and patients satisfaction. RESULTS: Eleven of 12 patients completed the study. At 1 month follow-up, AFXL-treated scars were significantly improved in pliability (POSAS P = 0.01 VSS P = 0.02) and smoother in surface relief (POSAS P = 0.03) compared to control scars. At 1-3 months, overall scar appearance was dominated by transient erythema and hyperpigmentation, confirmed by reflectance measurements (erythema% and pigmentation% peaked at 1 and 3 month follow-up, respectively). At 6 months follow-up, AFXL-treated scars improved on POSAS-total score though not significantly (P = 0.06). Correspondingly, blinded photo-evaluation found AFXL-treated scars significantly improved compared to controls (VAS P = 0.02). Histology indicated new dermal collagen and elastic fibers on AFXL-treated scars. At 6 months follow-up, a majority of patients (64%) favored subsequent AFXL-treatment of their untreated control scar tissue. CONCLUSIONS: Scar remodeling is initiated 1 month after AFXL treatment, but overall scar improvement is concealed until laser-induced color changes resolve. At 6 months follow-up, the benefit of AFXL treatment on c-section scars emerges. Lasers Surg. Med. 49:189-197, 2017. © 2016 Wiley Periodicals, Inc.

Parental Decisions about Prenatal Screening and Diagnosis among Infants with Trisomy 21 in a National Cohort with High Uptake of Combined First-Trimester Screening.

INTRODUCTION: The aim was to investigate the parental decisions about prenatal screening and diagnosis among infants with trisomy 21 (T21) in a national cohort with high uptake of combined first-trimester screening (cFTS). MATERIAL AND METHODS: This was a nationwide population-based study including infants born in 2009-2012. Information from the cFTS, fetal karyotype results and pregnancy outcome was obtained from the Danish Fetal Medicine Database on all women with a cFTS risk assessment. Cut-off for referral for invasive testing was ≥1:300. Karyotype results from pregnancies with no cFTS were obtained from the Danish Cytogenetic Central Registry. RESULTS: The uptake rate of cFTS was 91.6%, and 82.8% (8,032/9,704) of the screen-positive women opted for invasive testing. Overall, 82.2% (454/552) chose to terminate an affected pregnancy. In the 4-year period, 102 of 232,962 singletons were born alive with T21. The cFTS risk was true-positive, false-negative or not obtained in 21.6, 48.0 and 30.4%, respectively, of these pregnancies. DISCUSSION: In this large national cohort, 4.4 per 10,000 live-born infants had T21. Of 102 infants with T21 from 2009 to 2012, 52.0% were born after the women had not opted for cFTS or were true-positive but declined invasive testing or termination, and 48.0% were born after a false-negative risk assessment.

Linking quality of care and training costs: cost-effectiveness in health professions education.

OBJECTIVE: To provide a model for conducting cost-effectiveness analyses in medical education. The model was based on a randomised trial examining the effects of training midwives to perform cervical length measurement (CLM) as compared with obstetricians on patients' waiting times. (CLM), as compared with obstetricians. METHODS: The model included four steps: (i) gathering data on training outcomes, (ii) assessing total costs and effects, (iii) calculating the incremental cost-effectiveness ratio (ICER) and (iv) estimating cost-effectiveness probability for different willingness to pay (WTP) values. To provide a model example, we conducted a randomised cost-effectiveness trial. Midwives were randomised to CLM training (midwife-performed CLMs) or no training (initial management by midwife, and CLM performed by obstetrician). Intervention-group participants underwent simulation-based and clinical training until they were proficient. During the following 6 months, waiting times from arrival to admission or discharge were recorded for women who presented with symptoms of pre-term labour. Outcomes for women managed by intervention and control-group participants were compared. These data were then used for the remaining steps of the cost-effectiveness model. RESULTS: Intervention-group participants needed a mean 268.2 (95% confidence interval [CI], 140.2-392.2) minutes of simulator training and a mean 7.3 (95% CI, 4.4-10.3) supervised scans to attain proficiency. Women who were scanned by intervention-group participants had significantly reduced waiting time compared with those managed by the control group (n = 65; mean difference, 36.6 [95% CI 7.3-65.8] minutes; p = 0.008), which corresponded to an ICER of 0.45 EUR minute(-1) . For WTP values less than EUR 0.26 minute(-1) , obstetrician-performed CLM was the most cost-effective strategy, whereas midwife-performed CLM was cost-effective for WTP values above EUR 0.73 minute(-1) . CONCLUSION: Cost-effectiveness models can be used to link quality of care to training costs. The example used in the present study demonstrated that different training strategies could be recommended as the most cost-effective depending on administrators' willingness to pay per unit of the outcome variable.

The Danish Fetal Medicine Database: establishment, organization and quality assessment of the first trimester screening program for trisomy 21 in Denmark 2008-2012.

OBJECTIVE: To describe the establishment and organization of the Danish Fetal Medicine Database and to report national results of first-trimester combined screening for trisomy 21 in the 5-year period 2008-2012. DESIGN: National register study using prospectively collected first-trimester screening data from the Danish Fetal Medicine Database. POPULATION: Pregnant women in Denmark undergoing first-trimester screening for trisomy 21. METHODS: Data on maternal characteristics, biochemical and ultrasonic markers are continuously sent electronically from local fetal medicine databases (Astraia Gmbh software) to a central national database. Data are linked to outcome data from the National Birth Register, the National Patient Register and the National Cytogenetic Register via the mother's unique personal registration number. First-trimester screening data from 2008 to 2012 were retrieved. MAIN OUTCOME MEASURES: Screening performance was assessed for the years 2008-2012 by calculating detection rates and screen-positive rates. RESULTS: A total of 268 342 first-trimester risk assessments for trisomy 21 were performed in singleton pregnancies. Participation rate in first-trimester screening was >90%. The national screen-positive rate increased from 3.6% in 2008 to 4.7% in 2012. The national detection rate of trisomy 21 was reported to be between 82 and 90% in the 5-year period. CONCLUSION: A national fetal medicine database has been successfully established in Denmark. Results from the database have shown that at a national level first-trimester screening performance for trisomy 21 is high with a low screen-positive rate and a high detection rate.

Can a 15-mm cervical length cutoff discriminate between low and high risk of preterm delivery in women with threatened preterm labor?

OBJECTIVES: To investigate if a cervical length (CL) cutoff of 15 mm is relevant to use in women with threatened preterm labor. METHODS: From 2006 to 2009, 146 women with singleton pregnancies were admitted with threatened preterm labor between 23 and 33+6 weeks of gestation at Copenhagen University Hospital. Transvaginal sonographic measurement of CL was carried out on admission. Outcome measures were spontaneous delivery within 48 h, within 7 days and delivery before 34 weeks according to a CL cutoff of 15 mm. RESULTS: CL was <15 mm in 36 women (24.7%) and ≥15 mm in 110 women (75.3%). Spontaneous delivery occurred within 48 h or 7 days of presentation and before 34 weeks in 25, 38.9 and 50.0% of women with CL <15 mm and 3.6, 9.1 and 11.8% of women with CL ≥15 mm, respectively. The 15-mm CL cutoff had a sensitivity, false positive rate and negative predictive value for delivery within 48 h of 69.0, 20.3 and 96.4%, and within 7 days of 58.3, 18.1 and 90.9%. Women with CL <15 mm had odds of delivery within 7 days of 6.4 (95% CI 2.5-16.2). CONCLUSION: Although a 15-mm CL defines a group of women at high risk of spontaneous preterm delivery, 10 out of 110 women (9.1%) with a CL ≥15 mm deliver within 7 days.