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

High Risk Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355822
• Other study ID #: PETN_ESTG
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 16, 2011
• Last updated: May 26, 2011
• Start date: April 2002

Study information

• Verified date: May 2011
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• High Risk Pregnancy

Intervention

Drug:
• PETN
Pentaerythrithyltetranitrate: 80 mg orally twice a day
• Placebo control
orally, twice daily

Locations

Country	Name	City	State
Germany	University Hospital Jena, Department of Obstetrics	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile		19 -40 weeks of gestation	No
Secondary	Development of IUGR and severe IUGR defined as birth weight below the 5th percentile		19-40 weeks of gestation	No
Secondary	Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation		19 - 32 weeks of gestation	No
Secondary	Development of preeclampsia		19 - 40 weeks of gestation	No
Secondary	Any form of placental abruption		19 - 40 weeks of gestation	No