NCT01355822

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

Completed Phase 1/Phase 2 Last updated 26 May 2011

What this trial tests

Phase 1/Phase 2 trial testing PETN in High Risk Pregnancy in 111 participants. Completed.

Timeline

1 April 2002

Primary endpoint
1 January 2008

Quick facts

Lead sponsor	University of Jena
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	111
Start date	1 April 2002
Primary completion	1 January 2008
Sites	1 location across Germany

Drugs / interventions tested

• PETN — full drug profile →
• Placebo control

Conditions studied

• High Risk Pregnancy — all drugs for High Risk Pregnancy →

Sponsor

University of Jena

Who can join

Adults 18 to 50, female only, with High Risk Pregnancy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
  Time frame: 19 -40 weeks of gestation

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions affecting the nitric oxide pathway versus placebo or no therapy for fetal growth restriction in pregnancy.
   Pels A, Ganzevoort W, Kenny LC, Baker PN, et al · · 2023 · cited 12× · PMID 37428872 · DOI 10.1002/14651858.cd014498