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

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ClinicalTrials.gov Identifier: NCT01355822
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : May 27, 2011
Information provided by:
University of Jena

May 16, 2011
May 18, 2011
May 27, 2011
April 2002
January 2008   (Final data collection date for primary outcome measure)
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile [ Time Frame: 19 -40 weeks of gestation ]
Same as current
Complete list of historical versions of study NCT01355822 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study

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.

Not Provided
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
High Risk Pregnancy
  • Drug: PETN
    Pentaerythrithyltetranitrate: 80 mg orally twice a day
    Other Name: Pentalong®, , Actavis Germany, Langenfeld, Germany
  • Drug: Placebo control
    orally, twice daily
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo control
  • Experimental: PETN
    Pentalong, Actavis Germay: 80 mg twice a day
    Intervention: Drug: PETN
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • pregnant women 190 to 236 weeks of gestation
  • abnormal uterine Doppler as defined by bilateral notching, unilateral notching and increased impedance with mean resistance index (RI) > 0.65 or with mean RI > 0.7 without notching at time of enrollement
  • informed consent

Exclusion Criteria:

  • multiple gestation
  • documented chromosomal or major fetal abnormalities
  • rupture of membranes and/or clinical chorioamnionitis at time of enrolment
  • maternal disease defined as contraindication for intake of PETN
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Prof. Dr. Ekkehard Schleußner, University Hospital Jena, Deartmet og Obstetrics
University of Jena
Not Provided
Not Provided
University of Jena
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP