Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.

BACKGROUND: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. METHODS: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. DISCUSSION: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.

Predicting pulmonary hypoplasia with 2- or 3-dimensional ultrasonography in complicated pregnancies.

OBJECTIVE: The aim of this study was to compare 3-dimensional (3D) lung volume measurements with 2-dimensional (2D) biometric parameters in predicting pulmonary hypoplasia in complicated pregnancies. STUDY DESIGN: In this prospective study, 1-4 scans of the fetal lungs were obtained in 33 pregnancies complicated by various disorders or complications with regard to pulmonary hypoplasia. The 3D lung volumes vs gestational age or estimated fetal weight, the thoracic circumference vs gestational age or femur length, the thoracic/abdominal circumference ratio, and the thoracic/heart area ratio were measured. RESULTS: Of the 33 infants, 16 (48.5%) were diagnosed with pulmonary hypoplasia on postmortem examination or the clinical and radiological presentation. Three dimensional lung volume measurements had a better diagnostic accuracy for predicting pulmonary hypoplasia (sensitivity, 94%; specificity, 82%; positive predictive value [PPV], 83%; negative predictive value [NPV], 93%), compared with the best 2D biometric measurement thoracic/heart area ratio (sensitivity, 94%; specificity, 47%; PPV, 63%; NPV, 89%). CONCLUSION: 3D lung volume measurements seem to be useful in predicting pulmonary hypoplasia prenatally.

Two- or three-dimensional ultrasonography to predict pulmonary hypoplasia in pregnancies complicated by preterm premature rupture of the membranes.

OBJECTIVES: The purpose of this study was to compare 3D lung volume measurements with 2D biometric parameters in predicting pulmonary hypoplasia in pregnancies complicated by preterm premature rupture of the membranes (PPROM). METHODS: In this prospective study, 18 pregnancies complicated by PPROMs at a mean 21 weeks' gestation (range 14-32 weeks) were examined. The 3D lung volume measurements and the following 2D biometric parameters were measured: thoracic circumference (TC) versus gestational age or femur length (FL), the TC/abdominal circumference (AC) ratio and the thoracic area/heart area (TA/HA) ratio. The sensitivity, specificity, positive and negative predictive value of each measurement to diagnose pulmonary hypoplasia were compared. Pulmonary hypoplasia was diagnosed on the basis of clinical, radiological and/or pathologic criteria. RESULTS: The incidence of pulmonary hypoplasia was 33.3%. The best diagnostic accuracy for predicting pulmonary hypoplasia was achieved using the 3D lung volume measurements versus gestational age (sensitivity 83%, specificity 100%, positive predictive value 100% and negative predictive value 92%). CONCLUSIONS: Three-dimensional lung volume measurements seem to be promising in predicting pulmonary hypoplasia prenatally in pregnancies complicated by PPROM.

Prenatal diagnosis of aneurysms of the vein of Galen (vena magna cerebri) with conventional sonography, three-dimensional sonography, and magnetic resonance imaging: report of 2 cases.

OBJECTIVE: To describe the cases of 2 fetuses with aneurysms of the vein of Galen diagnosed prenatally. METHODS: The techniques used were conventional sonography, three-dimensional sonography, and ultrafast magnetic resonance imaging. On the basis of these imaging modalities, prognostic factors, such as drainage and secondary damage, were assessed. RESULTS: The first fetus had good prognostic indices, and embolization after birth was successful. According to the prognostic factors, a poor neonatal outcome was predicted for the second fetus. The neonate died soon after birth. CONCLUSIONS: Conventional sonography, color Doppler imaging, and magnetic resonance imaging appeared to be useful diagnostic tools. The prognostic factors can be useful in counseling patients and providing the best possible care after birth.