Trial with a drug containing the active agent PETN to improve the wellbeing of the mother and the baby in pregnancies which are at risk of undernutrition and retarded growth in the uterus (PETN Trial)

Pentaerithrityl tetranitrate (PETN) for secondary prevention of intrauterine growth restriction (PETN Trial) - PETN trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004396-51-DE

Enrollment

324

Registered

2017-02-13

Start date

2017-06-26

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women at risk of adverse pregnancy outcome due to intrauterine growth retardation identified by impaired uterine Doppler measurements at mid gestation (19+0 - 22+6 weeks of gestation). MedDRA version: 20.0 Level: PT Classification code 10070531 Term: Foetal growth restriction System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: Pentalong® 50 mg Pharmaceutical Form: Tablet INN or Proposed INN: Pentaneritrithyltetranitrate Other descriptive name: PENTAERYTHRITYL TETRANITRATE, DILUTED Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Abnormal uterine artery Doppler at 19+0 to 22+6 weeks of gestation, defined by a mean pulsatility index (PI) > 1.6 or at least exceeding the 95th percentile (Gomez 2008). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 324 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Fetal chromosomal or suspected major structural defects - Premature rupture of membranes at time of enrolment - Maternal disease defined as contraindication for intake of PETN

Design outcomes

Primary

Measure	Time frame
Main Objective: This trial investigates the efficacy and safety of PETN to reduce the incidence of intrauterine growth restriction, perinatal death and accompanied preterm delivery in women with insufficient placental development and uterine perfusion identified by pathological uterine artery Doppler at 19+0 to 22+6 weeks of gestation.;Secondary Objective: not applicable;Primary end point(s): development of intrauterine growth restriction (IUGR) or perinatal death (Composite);Timepoint(s) of evaluation of this end point: continuously; at visit at 24+0 to 24+6 weeks, visit at 28+0 to 28+6 weeks, visit at 32+0 to 32+6 weeks, visit at 36+0 to 36+6 weeks, visit at 38+0 to 40+0 weeks and after delivery	—

Measure

Time frame

Main Objective: This trial investigates the efficacy and safety of PETN to reduce the incidence of intrauterine growth restriction, perinatal death and accompanied preterm delivery in women with insufficient placental development and uterine perfusion identified by pathological uterine artery Doppler at 19+0 to 22+6 weeks of gestation.;Secondary Objective: not applicable;Primary end point(s): development of intrauterine growth restriction (IUGR) or perinatal death (Composite);Timepoint(s) of evaluation of this end point: continuously; at visit at 24+0 to 24+6 weeks, visit at 28+0 to 28+6 weeks, visit at 32+0 to 32+6 weeks, visit at 36+0 to 36+6 weeks, visit at 38+0 to 40+0 weeks and after delivery

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Secondary

Measure	Time frame
Secondary end point(s): - Severe morbidity and mortality as composite of severe IUGR (< birth weight below the 5th 3rd centile), intrauterine or neonatal death or placental abruption - Birth weight below the 3rd, 5th and 10th centile - Development of IUGR requiring delivery before 30 and before 34 weeks of gestation - Rate of neonatal intensive care unit admission - Neonatal need of ventilation and occurrence of intraventricular hemorrhage II – IV ° (IVH) and necrotized enterocolitis (NEC) - Spontanous preterm delivery < 34 weeks and < 37 weeks gestation;Timepoint(s) of evaluation of this end point: continuously; at visit at 24+0 to 24+6 weeks, visit at 28+0 to 28+6 weeks, visit at 32+0 to 32+6 weeks, visit at 36+0 to 36+6 weeks, visit at 38+0 to 40+0 weeks and after delivery	—

Measure

Time frame

Secondary end point(s): - Severe morbidity and mortality as composite of severe IUGR (< birth weight below the 5th 3rd centile), intrauterine or neonatal death or placental abruption - Birth weight below the 3rd, 5th and 10th centile - Development of IUGR requiring delivery before 30 and before 34 weeks of gestation - Rate of neonatal intensive care unit admission - Neonatal need of ventilation and occurrence of intraventricular hemorrhage II – IV ° (IVH) and necrotized enterocolitis (NEC) - Spontanous preterm delivery < 34 weeks and < 37 weeks gestation;Timepoint(s) of evaluation of this end point: continuously; at visit at 24+0 to 24+6 weeks, visit at 28+0 to 28+6 weeks, visit at 32+0 to 32+6 weeks, visit at 36+0 to 36+6 weeks, visit at 38+0 to 40+0 weeks and after delivery

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Countries

Germany

Contacts

Public ContactProject Manager

Jena University Hospital, Center for Clinical Studies

ZKS-Projektmanagement@med.uni-jena.de+4936419399969

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026