Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
High Risk Pregnancy |
Drug: PETN Drug: Placebo control |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study |
- 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 ]
- 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 ]
| Enrollment: | 111 |
| Study Start Date: | April 2002 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo control
orally, twice daily
|
|
Experimental: PETN
Pentalong, Actavis Germay: 80 mg twice a day
|
Drug: PETN
Pentaerythrithyltetranitrate: 80 mg orally twice a day
Other Name: Pentalong®, , Actavis Germany, Langenfeld, Germany
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Prof. Dr. Ekkehard Schleußner, University Hospital Jena, Deartmet og Obstetrics |
| ClinicalTrials.gov Identifier: | NCT01355822 History of Changes |
| Other Study ID Numbers: | PETN_ESTG |
| Study First Received: | May 16, 2011 |
| Last Updated: | May 26, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Jena:
|
abortion perinatal death IUGR |
preterm birth placental abruption preeclampsia |
ClinicalTrials.gov processed this record on May 23, 2013