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

Study Overview
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Brief Summary
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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.

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

Conditions
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High Risk Pregnancy

Intervention / Treatment
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* Drug: PETN
* Drug: Placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo control<br>* orally, twice daily<br>|
| Experimental: PETN<br>Pentalong, Actavis Germay: 80 mg twice a day | Drug: PETN<br>* Pentaerythrithyltetranitrate: 80 mg orally twice a day<br>* Other names: Pentalong®, , Actavis Germany, Langenfeld, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile |  | 19 -40 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of IUGR and severe IUGR defined as birth weight below the 5th percentile |  | 19-40 weeks of gestation | 
| Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation |  | 19 - 32 weeks of gestation | 
| Development of preeclampsia |  | 19 - 40 weeks of gestation | 
| Any form of placental abruption |  | 19 - 40 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abortion, perinatal death, IUGR, preterm birth, placental abruption, preeclampsia