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. Identifier: NCT01355822
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : May 27, 2011
Information provided by:
University of Jena

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.

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

Primary Outcome Measures :
  1. Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile [ Time Frame: 19 -40 weeks of gestation ]

Secondary Outcome Measures :
  1. Development of IUGR and severe IUGR defined as birth weight below the 5th percentile [ Time Frame: 19-40 weeks of gestation ]
  2. 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 ]
  3. Development of preeclampsia [ Time Frame: 19 - 40 weeks of gestation ]
  4. Any form of placental abruption [ Time Frame: 19 - 40 weeks of gestation ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01355822

University Hospital Jena, Department of Obstetrics
Jena, Thüringen, Germany, 07743
Sponsors and Collaborators
University of Jena

Responsible Party: Prof. Dr. Ekkehard Schleußner, University Hospital Jena, Deartmet og Obstetrics 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:
perinatal death
preterm birth
placental abruption