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Completed

NCT Number: NCT01355822

Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies

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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Key information

Conditions

High Risk Pregnancy Abruptio Placentae Death Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Placenta Diseases Pre-Eclampsia Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Jena, Department of Obstetrics

Jena, Thuringia, 07743, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PETN

Drug

Pentaerythrithyltetranitrate: 80 mg orally twice a day

Other names: Pentalong®, , Actavis Germany, Langenfeld, Germany

Placebo Control

Drug

orally, twice daily

Primary outcomes

  1. Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile

    Time frame: 19 -40 weeks of gestation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study

Important dates

Study start
2002
Primary completion
2008
First posted
May 18, 2011
Registry last updated
May 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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