Clinical Trial: Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study

Brief Summary:

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.


Detailed Summary:
Sponsor: University of Jena

Current Primary Outcome: Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile [ Time Frame: 19 -40 weeks of gestation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Jena

Dates:
Date Received: May 16, 2011
Date Started: April 2002
Date Completion:
Last Updated: May 26, 2011
Last Verified: May 2011