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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 16, 2011
Last Updated Date	May 26, 2011
Start Date ^ICMJE	April 2002
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 16, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01355822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 16, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	High Risk Pregnancy
Intervention ^ICMJE	Drug: PETN Pentaerythrithyltetranitrate: 80 mg orally twice a day Other Name: Pentalong®, , Actavis Germany, Langenfeld, Germany Drug: Placebo control orally, twice daily
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo control Experimental: PETN Pentalong, Actavis Germay: 80 mg twice a day Intervention: Drug: PETN
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	111
Completion Date	Not Provided
Primary Completion Date	January 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01355822
Other Study ID Numbers ^ICMJE	PETN_ESTG
Has Data Monitoring Committee	No
Responsible Party	Prof. Dr. Ekkehard Schleußner, University Hospital Jena, Deartmet og Obstetrics
Study Sponsor ^ICMJE	University of Jena
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Jena
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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