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

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01355822
First received: May 16, 2011
Last updated: May 26, 2011
Last verified: May 2011

May 16, 2011
May 26, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Development of preeclampsia [ Time Frame: 19 - 40 weeks of gestation ] [ Designated as safety issue: No ]
  • Any form of placental abruption [ Time Frame: 19 - 40 weeks of gestation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01355822
PETN_ESTG
No
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