High Risk Pregnancy
Conditions
Keywords
abortion, perinatal death, IUGR, preterm birth, placental abruption, preeclampsia
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.
Interventions
DRUGPETN
Pentaerythrithyltetranitrate: 80 mg orally twice a day
DRUGPlacebo control
orally, twice daily
Sponsors
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile | 19 -40 weeks of gestation |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed