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

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01355822
First received: May 16, 2011
Last updated: May 26, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355822

Locations
Germany
University Hospital Jena, Department of Obstetrics
Jena, Thüringen, Germany, 07743
Sponsors and Collaborators
University of Jena
  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 September 22, 2014