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

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

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.

Study Overview

• Status: Completed
• Conditions: High Risk Pregnancy
• Intervention / Treatment: Drug: Placebo control; Drug: PETN

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Thüringen
    • Jena, Thüringen, Germany, 07743
      • University Hospital Jena, Department of Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Pentalong®, , Actavis Germany, Langenfeld, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile	19 -40 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Time Frame
Development of IUGR and severe IUGR defined as birth weight below the 5th percentile	19-40 weeks of gestation
Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation	19 - 32 weeks of gestation
Development of preeclampsia	19 - 40 weeks of gestation
Any form of placental abruption	19 - 40 weeks of gestation

Collaborators and Investigators

• Sponsor: University of Jena

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2011
• Last Update Submitted That Met QC Criteria: May 26, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: preterm birth; abortion; IUGR; preeclampsia; placental abruption; perinatal death
• Other Study ID Numbers: PETN_ESTG