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

University of Jena

Status and phase: Completed; Phase 2; Phase 1

Conditions: High Risk Pregnancy

Treatments: Drug: PETN; Drug: Placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT01355822

PETN_ESTG

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo control

PETN

Experimental group

Description:

Pentalong, Actavis Germay: 80 mg twice a day

Treatment:

Drug: PETN