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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PETN | Experimental | Pentalong, Actavis Germay: 80 mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PETN | Drug | Pentaerythrithyltetranitrate: 80 mg orally twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile | 19 -40 weeks of gestation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Jena, Department of Obstetrics | Jena | Thuringia | 07743 | Germany |
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| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| D047928 | Premature Birth |
| D000037 | Abruptio Placentae |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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| Placebo control | Drug | orally, twice daily |
|
| Development of preeclampsia | 19 - 40 weeks of gestation |
| Any form of placental abruption | 19 - 40 weeks of gestation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D010922 | Placenta Diseases |
| D046110 | Hypertension, Pregnancy-Induced |