Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial.

OBJECTIVE: To assess whether antibiotics used for treatment in asymptomatic second-trimester women positive for Mycoplasma or Ureaplasma spp. detected by amniotic-fluid PCR prevents preterm delivery. DESIGN: A randomized, double-blind, placebo-controlled trial. SETTING: 10 maternal fetal medicine centers in France. POPULATION: Women with a singleton pregnancy who underwent amniocentesis between 16 and 20 weeks' gestation (weeks) for Down syndrome screening. A sample of 238 women with PCR-positive findings per treatment group was needed to show a 50% reduction in the preterm delivery rate. METHODS: Amniotic fluid was tested. Women with positive findings on real-time PCR of amniotic fluid for Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum and Ureaplasma parvum were randomized to receive josamycin or placebo. Amniotic fluid was also tested for 16S PCR. MAIN OUTCOME MEASURES: The primary outcome was delivery before 37 weeks. RESULTS: In total, 1043 women underwent amniotic-fluid screening with specific PCR detection between July 2008 and July 2011: PCR detection failed in 27 (2.6%), and 20 (1.9%) underwent termination of pregnancy. Among the 1016 women with PCR results, 980 had available data for the primary outcome (delivery before 37 weeks) and 29 (3.0%) were positive for Ureaplasma and/or Mycoplasma spp. Because of the low rate of women with PCR-positive findings, the trial was stopped prematurely. In total, 19 women were randomized to receive placebo (n = 8) or josamycin (n = 11) and their characteristics were comparable, as was the rate of preterm delivery and secondary outcomes. In comparing all PCR-positive and -negative women regardless of treatment, PCR positivity for Ureaplasma and/or Mycoplasma spp. was not associated with any adverse pregnancy or neonatal outcome. Amniotic-fluid screening by 16S PCR showed no other bacterial colonization associated with preterm birth. CONCLUSIONS: Because of a low amniotic fluid colonization rate, the trial was interrupted. Maternal amniotic-fluid colonization by Mycoplasma and/or Ureaplasma spp. at 16-20 weeks in asymptomatic women is rare and not associated with adverse pregnancy outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT00718705.

The performance of an intermediate 16th-week ultrasound scan for the follow-up of euploid fetuses with increased nuchal translucency.

OBJECTIVE: The objective of the study is to assess the utility of an intermediate ultrasound scan at 16(+0) to 18(+6) weeks of gestation in euploid fetuses with increased nuchal translucency ≥ 3.5 mm. METHODS: Three hundred eighty-nine fetuses with nuchal translucency (NT) ≥ 3.5 mm were identified in two prenatal centers between January 2008 and December 2012. Pregnancy work-up included karyotyping, monthly detailed ultrasound scan starting with a 16th-week scan, a cardioechography, and a genetic counseling. Abnormal findings and pregnancy outcomes were analyzed retrospectively. RESULTS: Of the 389 fetuses included, 52% had normal karyotype. Among euploid fetuses, 51 (30.7%) structural defects were identified overall. First-trimester scan was useful to identify 16 of the major defects (31.3%), and the 16th-week scan was useful to identify an additional 21 of them (41.2%), whereas the 22nd-week pregnancy scan discovered an additional 14 (27.4%). Structural defects discovered with the 16th-week scan were cardiac defects (n = 7), polymalformative syndromes (n = 3), left diaphragmatic hernias (n = 3), limbs abnormalities (n = 2), genitourinary (n = 2), microretrognathism (n = 2), hydrops (n = 1), and exomphalos (n = 1). If the intermediate scan was normal, the chances of a favorable outcome were as high as 85% and were close to 100% after 20 weeks, irrespective of initial NT. CONCLUSION: The intermediate ultrasound was useful in fetuses with increased NT pregnancy work-up.

Randomized Clinical Trial of Virtual Reality Simulation Training for Transvaginal Gynecologic Ultrasound Skills.

OBJECTIVES: To compare the impact of virtual reality simulation training and theoretical teaching on the ability of inexperienced trainees to produce adequate virtual transvaginal ultrasound images. METHODS: We conducted a randomized controlled trial with parallel groups. Participants included inexperienced residents starting a training program in Paris. The intervention consisted of 40 minutes of virtual reality simulation training using a haptic transvaginal simulator versus 40 minutes of conventional teaching including a conference with slides and videos and answers to the students' questions. The outcome was a 19-point image quality score calculated from a set of 4 images (sagittal and coronal views of the uterus and left and right ovaries) produced by trainees immediately after the intervention, using the same simulator on which a new virtual patient had been uploaded. Experts assessed the outcome on stored images, presented in a random order, 2 months after the trial was completed. They were blinded to group assignment. The hypothesis was an improved outcome in the intervention group. Randomization was 1 to 1. RESULTS: The mean score was significantly greater in the simulation group (n = 16; mean score, 12; SEM, 0.8) than the control group (n = 18; mean score, 9; SEM, 1.0; P= .0302). CONCLUSIONS: The quality of virtual vaginal images produced by inexperienced trainees was greater immediately after a single virtual reality simulation training session than after a single theoretical teaching session.

Prenatal BACs-on-Beads™: the prospective experience of five prenatal diagnosis laboratories.

OBJECTIVE: We previously reported on the validation of Prenatal BACs-on-Beads™ on retrospectively selected and prospective prenatal samples. This bead-based multiplex assay detects chromosome 13, 18, 21 and X/Y aneuploidies and the nine most frequent microdeletion syndromes. We demonstrated that Prenatal BACs-on-Beads(TM) is a new-generation, prenatal screening tool. Here, we describe the experience of five European prenatal diagnosis laboratories concerning the ongoing use of Prenatal BACs-on-Beads™ . METHODS: Some 1653 samples were analyzed. All results were confirmed by conventional karyotyping or another appropriate technique. All indications for invasive prenatal diagnosis were included. Amniotic fluid and chorionic villus samples were analyzed in equivalent proportions. RESULTS: The failure rate was 3.3% and the overall abnormality detection rate was ~1/10. Eighty-five percent of the detected abnormalities were common aneuploidies. Eleven microdeletions and duplications were identified, thus giving an overall yield for microdeletion and microduplication detection of 1/145. Compared with QF-PCR, Prenatal BACs-on-Beads™ provides an additional detection rate of ~1/250 for low-risk pregnancies. The false positive and negative rates were both <1%. CONCLUSION: When associated with conventional karyotyping, the Prenatal BACs-on-Beads™ assay combines a short turnaround time (typical of rapid aneuploidy detection tests) with valuable detection of the most frequent microdeletion syndromes that cannot be detected in cytogenetic analyses.

Laparoscopic partial splenectomy using radiofrequency ablation.

INTRODUCTION: Epidermoid cysts are believed to be congenital in origin and often present in the pediatric population. Because of the concerns of compromised immunologic function after total splenectomy and increasing demand for minimally invasive approaches, interest has increased in performing the partial splenectomy in this patient population by laparoscopic techniques. Nonetheless, concerns for adequate hemostasis have limited its widespread adoption. Because radiofrequency ablation for the partial splenectomy has been done in a laparoscopic porcine model with good results, we used this technology with the goal of limiting blood loss and postoperative hemorrhagic complications. CASE REPORT: A 25-year-old female presented with complaints of right shoulder pain. Abdominal ultrasound and a computed tomography (CT) scan revealed a 10-cm cystic lesion of the spleen. Serology was negative for hydatid cyst pathology. The patient underwent an uneventful partial splenectomy by minimally invasive techniques with the aid of a laparoscopic radiofrequency ablative device and the placement of a hemostatic medicated sponge along the line of transection. RESULTS: Estimated blood loss was less than 30 mL. Final pathology was consistent with an epidermoid splenic cyst, and the patient was discharged uneventfully on postoperative day 5. DISCUSSION: Techniques for the treatment of symptomatic splenic cysts range from total splenectomy to cyst fenestration and placement of the omentum in the splenic defect. The use of radiofrequency ablation has been traditionally used for hepatic parenchymal transection but seems equally suited for the partial splenectomy. This technology, and the addition of hemostatic sponges, seems to provide excellent results in minimizing blood loss, intraoperatively and postoperatively, during the laparoscopic partial splenectomy; however, randomized, prospective trials will be necessary to see if they will be superior to traditional techniques.

The lateral infraureteral parametrium: myth or reality?

OBJECTIVE: The objective of the study was to describe the surgical anatomy of infraureteral parametrium. STUDY DESIGN: Findings of laparoscopic dissections during 12 type III radical hysterectomies were compared with findings obtained by bilateral pelvic dissections of 5 fresh and 5 embalmed female cadavers and to magnetic resonance imaging of 10 healthy controls. RESULTS: Two anatomical entities of the parametrium were distinguished: (1) the lateral mesometrium corresponding to the blade containing vessels and lymph nodes of the uterus; and (2) the infraureteral parametrium extending dorsally from cervix and vagina. The lateral paracervix classically described under the ureter was never identified. Infraureteral parametrium appeared as a fibrous tissue extending in a lateral, dorsal, and caudal direction on both sides of the rectum and very close to the pelvic plexus. CONCLUSION: Our results attest to the absence of infraureteral parametrium, raising the issue of the surgical relevance of radical hysterectomy classification and the redefinition of the concept of radical hysterectomy.