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

NCT01355822 — Phase 1 / Phase 2, Completed, 111 participants, University of Jena

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

Registry	NCT01355822
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	111 (Actual)
Sponsor	University of Jena (Other)
Conditions	High Risk Pregnancy
Interventions	PETN, Placebo control (Drug)
Dates	start 2002-04-01, primary completion 2008-01-01, first posted 2011-05-18, last updated 2011-05-27
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Drug: Placebo control
PETN	Experimental	Drug: PETN	Pentalong, Actavis Germay: 80 mg twice a day

PETN (Drug), also known as Pentalong®, , Actavis Germany, Langenfeld, Germany: Pentaerythrithyltetranitrate: 80 mg orally twice a day
Placebo control (Drug): orally, twice daily

+Outcome measures

Primary outcomes

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

Secondary outcomes

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]

+Eligibility

Sex: Female, ages: 18 Years to 50 Years

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

+Locations (1)

Facility	City	Country	Status
University Hospital Jena, Department of Obstetrics	Jena, Thuringia	Germany