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

Phase 1

Completed

• Conditions: High Risk Pregnancy
• Interventions: Drug: Placebo control; Drug: PETN

• Registration Number: NCT01355822
• Lead Sponsor: University of Jena

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2008-01
• Status Verified: 2011-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-18
• Last Update Submitted: 2011-05-26
• Last Update Posted: 2011-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo control	-
PETN	PETN	Pentalong, Actavis Germay: 80 mg twice a day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Jena, Department of Obstetrics; 🇩🇪 Jena, Thüringen, Germany