Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk. The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
111
Pentaerythrithyltetranitrate: 80 mg orally twice a day
orally, twice daily
University Hospital Jena, Department of Obstetrics
Jena, Thuringia, Germany
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
Time frame: 19 -40 weeks of gestation
Development of IUGR and severe IUGR defined as birth weight below the 5th percentile
Time frame: 19-40 weeks of gestation
Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation
Time frame: 19 - 32 weeks of gestation
Development of preeclampsia
Time frame: 19 - 40 weeks of gestation
Any form of placental abruption
Time frame: 19 - 40 weeks of gestation
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