Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01355822 |
Recruitment Status
:
Completed
First Posted
: May 18, 2011
Last Update Posted
: May 27, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
High Risk Pregnancy | Drug: PETN Drug: Placebo control | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 111 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | April 2002 |
Actual Primary Completion Date : | January 2008 |
Arm | Intervention/treatment |
---|---|
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
|
- Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile [ Time Frame: 19 -40 weeks of gestation ]
- Development of IUGR and severe IUGR defined as birth weight below the 5th percentile [ Time Frame: 19-40 weeks of gestation ]
- 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 ]
- Development of preeclampsia [ Time Frame: 19 - 40 weeks of gestation ]
- Any form of placental abruption [ Time Frame: 19 - 40 weeks of gestation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355822
Germany | |
University Hospital Jena, Department of Obstetrics | |
Jena, Thüringen, Germany, 07743 |
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 |
First Posted: | May 18, 2011 Key Record Dates |
Last Update Posted: | May 27, 2011 |
Last Verified: | May 2011 |
Keywords provided by University of Jena:
abortion perinatal death IUGR |
preterm birth placental abruption preeclampsia |