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

NCT01355822 | Completed Phase 1

• 1 other identifier: PETN_ESTG
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Pregnancy

Keywords

abortion; perinatal death; IUGR; preterm birth; placental abruption; preeclampsia

Outcome Measures

Primary Outcomes (1)

• Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile

  19 -40 weeks of gestation

Secondary Outcomes (4)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo control

PETN

EXPERIMENTAL

Pentalong, Actavis Germay: 80 mg twice a day

Drug: PETN

Interventions

PETN DRUG

Pentaerythrithyltetranitrate: 80 mg orally twice a day

Also known as: Pentalong®, , Actavis Germany, Langenfeld, Germany

PETN

Placebo control DRUG

orally, twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

University Hospital Jena, Department of Obstetrics

Jena, Thuringia, 07743, Germany

Location

MeSH Terms

Conditions

Perinatal Death; Premature Birth; Abruptio Placentae; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Placenta Diseases; Hypertension, Pregnancy-Induced

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: April 1, 2002
• Primary Completion: January 1, 2008
• Last Updated: May 27, 2011

Record last verified: 2011-05

Locations

DE (1)