Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
NCT ID: NCT01355822
Last Updated: 2011-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
111 participants
INTERVENTIONAL
2002-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo control
orally, twice daily
PETN
Pentalong, Actavis Germay: 80 mg twice a day
PETN
Pentaerythrithyltetranitrate: 80 mg orally twice a day
Interventions
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PETN
Pentaerythrithyltetranitrate: 80 mg orally twice a day
Placebo control
orally, twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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University of Jena
OTHER
Responsible Party
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University Hospital Jena, Deartmet og Obstetrics
Locations
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University Hospital Jena, Department of Obstetrics
Jena, Thuringia, Germany
Countries
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Other Identifiers
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PETN_ESTG
Identifier Type: -
Identifier Source: org_study_id
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