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PETN in high-risk pregnancies
NCT01355822Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2002
- Primary completion
- Jan 2008
- Countries
- 1
- Sponsor
- Friedrich Schiller University Jena
- Modality
- Small Molecules
- Conditions
- intrauterine growth restriction (IUGR)preeclampsiaplacental abruptionpreterm birth
01
Overview
Phase 2, randomised, double-blind trial in intrauterine growth restriction (IUGR), preeclampsia, placental abruption and 1 more comparing PETN with Placebo (2 arms). Primary endpoint: Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile. Started Apr 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PETN
Pentaerythrityl tetranitrate 80 mg twice daily
Placebo
Placebo twice daily
03
Who it enrols
Pregnant women at 19-24 weeks gestation with abnormal uterine Doppler (bilateral notching, unilateral notching with increased impedance, or mean RI > 0.7).
04
Endpoints
Primary
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
Secondary
Development of IUGR and severe IUGR defined as birth weight below the 5th percentile
Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation
Development of preeclampsia
Any form of placental abruption
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