Impact of the nitric oxide-donor pentaerythrityl-tetranitrate on perinatal outcome in risk pregnancies: a prospective, randomized, double-blinded trial
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Ekkehard Schleussner
, Thomas Lehmann
, Christiane Kähler , Uwe Schneider , Dietmar Schlembach and Tanja Groten
Abstract
Intrauterine growth restriction (IUGR) and preeclampsia (PE) are associated with impaired placentation. Patients who are at risk of developing both these disorders can be identified by abnormal uterine artery Doppler at mid-trimester pregnancy. Nitric oxide (NO)-donors like pentaerithrityl-tetranitrate (PETN) reduce the impedance in the uteroplacental vessels and possess protecting effects on the endothelium. We tested the effectiveness of the NO-donor PETN for secondary prevention of IUGR, PE, and preterm birth in pregnancies at risk. Some 111 women who presented with abnormal placental perfusion at 19–24 weeks of gestation (w.o.g.) were included into a prospective, randomized, placebo-controlled, double-blinded study. The primary endpoint was IUGR and/or perinatal death. Secondary endpoints were preterm birth, PE, and placental abruption. Pentaerithrityl-tetranitrate significantly decreased the risk for IUGR and/or perinatal death [adjusted relative risk (RR) 0.410; 95% confidence interval, CI, 0.184–0.914] and for IUGR (adjusted RR 0.436; 95% CI 0.196–0.970). Preterm birth before 32 w.o.g. (adjusted RR 0.204; 95% CI 0.052–0.801) was reduced, but not the risk for PE. No placental abruption occurred in the PETN, but five occurred in the placebo group. These results suggest that secondary prophylaxis of adverse pregnancy outcome might be feasible in pregnancies exhibiting abnormal placentation using PETN.
Institute of origin: Department of Obstetrics, University Hospital Jena, Bachstr. 18, 07743 Jena, Germany. The trial is registered at ClinicalTrials.gov, number: NCT01355822 http://clinicaltrials.gov/ct2/show/NCT01355822.
Acknowledgments
We would like to thank the clinical pharmacist of the University Hospital Jena, Dr. Michael Hartmann, PhD for providing and handling the study medication, the research midwives Andrea Schröter and Ute Koerbs for their excellent assistance in patient care, and Dr. Heike Hoyer, PhD for biometric consulting.
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©2014 by Walter de Gruyter Berlin/Boston
Articles in the same Issue
- Frontmatter
- Review articles
- The relationship between gestational weight gain and fetal growth: time to take stock?
- Risk factors for pregnancy-associated venous thromboembolism: a review
- Academy’s Corner
- Africa is only 14 km away from my country
- Primary prevention of preterm birth
- Original articles – Obstetrics
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- Silent chorioamnionitis and associated pregnancy outcomes: a review of clinical data gathered over a 16-year period
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- Differences between external and internal fetal heart rate monitoring during the second stage of labor: a prospective observational study
- Perinatal management of preterm premature ruptured membranes affects neonatal prognosis
- Impact of the nitric oxide-donor pentaerythrityl-tetranitrate on perinatal outcome in risk pregnancies: a prospective, randomized, double-blinded trial
- Umbilical vein volume flow in monochorionic twin pairs at 11–14 weeks
- Gestational weight gain according to number of fetuses in Japanese women
- Original article – Fetus
- Prenatal diagnosis of sex chromosome aneuploidies and disorders of sex development – a retrospective analysis of 11-year data
- Short communication
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- Congress Calendar
- Congress Calendar
Articles in the same Issue
- Frontmatter
- Review articles
- The relationship between gestational weight gain and fetal growth: time to take stock?
- Risk factors for pregnancy-associated venous thromboembolism: a review
- Academy’s Corner
- Africa is only 14 km away from my country
- Primary prevention of preterm birth
- Original articles – Obstetrics
- Mother knows best? Comparing primiparous parturients’ expectations and predictions with actual birth outcomes
- Silent chorioamnionitis and associated pregnancy outcomes: a review of clinical data gathered over a 16-year period
- Clinical factors associated with failed trials of labor in late preterm and term twin pregnancies
- Relation of placental diagnosis in stillbirth to fetal maceration and gestational age at delivery
- Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery
- The relationship of praise/criticism to learning during obstetrical simulation: a randomized clinical trial
- Sickle cell disease and pregnancy outcomes: population-based study on 8.8 million births
- Differences between external and internal fetal heart rate monitoring during the second stage of labor: a prospective observational study
- Perinatal management of preterm premature ruptured membranes affects neonatal prognosis
- Impact of the nitric oxide-donor pentaerythrityl-tetranitrate on perinatal outcome in risk pregnancies: a prospective, randomized, double-blinded trial
- Umbilical vein volume flow in monochorionic twin pairs at 11–14 weeks
- Gestational weight gain according to number of fetuses in Japanese women
- Original article – Fetus
- Prenatal diagnosis of sex chromosome aneuploidies and disorders of sex development – a retrospective analysis of 11-year data
- Short communication
- Reference range for amniotic fluid index measurements in a Brazilian population
- Congress Calendar
- Congress Calendar