Pentaerythrityl tetranitrate improves the outcome of children born to mothers with compromised uterine perfusion-12-months follow-up and safety data of the double-blind randomized PETN trial.

BACKGROUND: This is a follow-up study to the pentaerythrityl tetranitrate randomized controlled multicenter trial that reports neonatal outcome data of newborns admitted to neonatal intensive care units and outcome data of the offspring at 12 months of age. OBJECTIVE: We present data on adverse events reported during the study to document the safety of pentaerythrityl tetranitrate treatment during pregnancy. To further evaluate the effects of pentaerythrityl tetranitrate on neonatal and long-term outcomes, we present follow up data from of 240 children at 12 months of age, including information on height, weight, head circumference, developmental milestones, and the presence of chronic disease and of 144 newborns admitted to the neonatal intensive care unit during the trial. STUDY DESIGN: The pentaerythrityl tetranitrate trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of the nitric oxide-donor pentaerythrityl tetranitrate in the prevention of fetal growth restriction and perinatal death in pregnancies complicated by abnormal placental perfusion. RESULTS: Results at 12 months demonstrated that significantly more children were age appropriately developed without impairments in the pentaerythrityl tetranitrate group (P=.018). In addition, the presence of chronic disease was lower in the pentaerythrityl tetranitrate group (P=.041). Outcome data of the 144 newborns admitted to the neonatal intensive care unit did not reveal differences between the treatment and placebo groups. There were no differences in the number or nature of reported adverse events between the study groups. CONCLUSION: The analysis shows that study children born in the pentaerythrityl tetranitrate cohort have a clear advantage compared with the placebo group at the age of 12 months, as evidenced by the increased incidence of normal development without the presence of chronic disease. Although safety has been proven, further follow-up studies are necessary to justify pentaerythrityl tetranitrate treatment during pregnancies complicated by impaired uterine perfusion.

Postoperative anatomic and quality-of-life outcomes after vaginal sacrocolporectopexy for vaginal vault prolapse.

OBJECTIVE: To assess anatomic outcome and quality of life (QOL) after vaginal sacrocolporectopexy among patients with pelvic organ prolapse. METHODS: A noncomparative observational study was conducted at Hanover Medical School, Germany, among patients who underwent vaginal sacrocolporectopexy for uterine or vaginal vault prolapse between May 1, 2006, and October 31, 2012. A validated German version of the Prolapse QOL (P-QOL) questionnaire was sent to eligible patients; respondents were invited for follow-up examination. RESULTS: Overall, 128 patients were enrolled. Concomitant hysterectomy was performed among 82 (64.1%) patients, anterior colporrhaphy among 105 (82.0%), and posterior colporrhaphy among 58 (45.3%). After a mean interval of 26.5 months (range 1.0-81.3 months), seven patients exhibited recurrent vaginal vault prolapse of at least stage 2, giving a success rate of 92.3% (95% confidence interval 85.9%-96.5%). The P-QOL scores were either low (<40) or very low (<20), indicating high QOL. Regarding symptoms related to pelvic organ prolapse, patients reported little or no impact on QOL after vaginal sacrocolporectopexy. CONCLUSION: Vaginal sacrocolporectopexy seemed safe and feasible, leading to anatomically correct fixation of the vaginal apex, high anatomic success rates, and good QOL. This procedure might be considered as an alternative to laparoscopic or abdominal sacrocolpopexy.