Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pentaerithrityl Tetranitrate (PETN) for Secondary Prevention of Intrauterine Growth Restriction (PETN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669185
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jena University Hospital

Brief Summary:
Approximately 10% of all pregnancies experience mal perfusion of the placenta resulting in fetal growth restriction (FGR) of the fetus. FGR is the most important cause of perinatal mortality and morbidity. Impaired placental function determined by insufficient transformation of the uterine arteries and mal-perfusion of the placenta is the leading cause of FGR. So far, there is no treatment option for pregnancies complicated by FGR and the clinical management is restricted to close monitoring, assessing for the optimal time point of delivery of the fetus threatened by intrauterine death. In a pilot study a risk reduction of 38% for the development of severe FGR and FGR or death could be demonstrated by giving the organic nitrate pentaerithrityl-tetranitrate (PETN) to patients recognized at risk for FGR by impaired uterine artery Doppler at mid gestation (Schleussner, 2014). To confirm these results this prospective randomized placebo controlled double-blinded multicentre trial, was initiated.

Condition or disease Intervention/treatment Phase
Fetal Growth Retardation Pregnancy Related Intrauterine Growth Restriction Drug: Pentalong Drug: Placebos Phase 3

Detailed Description:

Affecting approximately 10% of pregnancies, fetal growth restriction (FGR), is the most important cause of perinatal mortality and morbidity. Impaired placental function determined by insufficient transformation of the uterine arteries and mal-perfusion of the placenta is the leading cause of FGR. So far, there is no treatment option for pregnancy complicated by FGR and the clinical management is restricted to close monitoring, assessing for the optimal time point of delivering the fetus threatened by intrauterine death. In a prospective randomized controlled trial a risk reduction of 38% (relative risk RR=0.609, 95% CI 0.367 to 1.011) for the development of IUGR and IUGR or death (RR=0.615, 95% CI 0.378 to 1.000) could be demonstrated by delivering the organic nitrate pentaerithrityl-tetranitrate (PETN) to patients recognized at risk for FGR by impaired uterine artery Doppler at mid gestation (Schleussner, 2014). To confirm these results a prospective randomized placebo controlled double-blinded multicentre trial was now initiated.

Eligible patients are pregnant women at risk of developing FGR meeting the inclusion criteria: abnormal uterine artery Doppler ultrasound, defined by a mean PI exceeding 1.6, singleton pregnancy, informed consent and 19+0 to 22+6 weeks of gestation. The composite endpoint of severe FGR (< birth weight below the 3rd centile) and intrauterine or neonatal death was defined as primary efficacy endpoint. and perinatal death. Key secondary endpoints are development of FGR (defined by birth weight < 10th percentile), severe FGR (< birth weight below the 3rd centile), intrauterine or neonatal death, placental abruption and preterm birth.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pentaerithrityltetranitrat (PETN) Zur Sekundärprophylaxe Der Intrauterinen Wachstumsretardierung
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 31, 2020

Arm Intervention/treatment
Placebo Comparator: Placebos
Placebos, 2 times daily 1 tablet, intake max. 133 days
Drug: Placebos
Placebos, 2 x daily 1 tablet, intake max. 133 days

Active Comparator: Pentalong
Pentalong, 2 times daily 1 tablet, intake max. 133 days
Drug: Pentalong
Pentalong, 2 x daily 1 tablet, intake max. 133 days
Other Names:
  • Pentaeritrithyl tetranitrate
  • Pentalong® 50 mg




Primary Outcome Measures :
  1. Number of participants who develop intrauterine/fetal growth restriction or perinatal death. [ Time Frame: 19 weeks of pregnancy - seventh day of life ]
    Efficiency of PETN to prevent the development of intrauterine/fetal growth restriction or perinatal death.


Secondary Outcome Measures :
  1. severe morbidity [ Time Frame: 19 weeks of pregnancy - seventh day of life ]
    severe morbidity as a combined result of severe FGR (birth weight below the 3rd or 5th percentile) or perinatal death or premature abruption of placenta

  2. birth weight [ Time Frame: 19-40 weeks of pregnancy ]
    percentage of children with birth weight below the 3rd, 5th or 10th percentile

  3. Number of participants who developed FGR [ Time Frame: 19-40 weeks of pregnancy ]
    Number of participants who developed FGR, which necessitates delivery before 30 and 34 week of gestation

  4. admission to NICU [ Time Frame: Birth to discharge from the hospital ]
    rate of newborns transferred to neonatal intensive care unit

  5. infant outcome [ Time Frame: birth to discharge from NICU ]
    rate of newborns with intraventricular cerebral haemorrhage (grade II - IV) or necrotizing enterocolitis, b.o.

  6. number of premature deliveries [ Time Frame: 19 to 37 weeks of gestation ]
    number of premature deliveries before completed 34 and 37 weeks of gestation

  7. mortality [ Time Frame: 19 weeks of pregnancy - seventh day of life ]
    number of perinatal deaths



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women between pregnancy week 19+0 and 22+6
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • abnormal uterine artery Doppler at 19+0 to 22+6 weeks of gestation, defined by a mean pulsatility index (PI) Exceeding 1.6
  • singleton pregnancy
  • age>/= 18 years
  • informed consent

Exclusion Criteria:

  • known fetal chromosomal or suspected major structural defects at time of enrollment
  • premature rupture of membranes at time of enrolment; maternal disease defined as contraindication for intake of PETN
  • anamnestic known insensitivity to Pentalong® or its ingredients or to medications with similar chemical structure
  • participation of the patient in another clinical trial (parallel or within the waiting period of a previous clinical trial)
  • multiple pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669185


Contacts
Layout table for location contacts
Contact: Tanja Groten, PD Dr. +49 3641 9 329207 petn@med.uni-jena.de
Contact: Ekkehard Schleußner, Prof. Dr. +49 3641 9 329207 petn@med.uni-jena.de

Locations
Layout table for location information
Germany
Universitäts-Frauenklinik Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Karl O Kagan, Dr.         
Contact: Harald Abele, Prof. Dr.         
Universitätsklinikum Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89075
Contact: Ulrike Friebe-Hoffmann, PD Dr.         
Contact: Wolfgang Janni, Prof. Dr.         
Klinikum der Universität München Recruiting
München, Bayern, Germany, 81377
Contact: Christoph Hübener, Dr.         
Contact: Maria Delius, Dr.         
Städtisches Klinikum München Recruiting
München, Bayern, Germany, 81545
Contact: Laura de Vries, Dr.         
Contact: Ninette Scharle         
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Constantin von Kaisenberg, Pr. Dr.         
Contact: Matthias Jentschke, Dr.         
Universitätsklinikum Bonn Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53127
Contact: Mateja Condic         
Contact: Julia Welz         
Krankenhaus St. Elisabeth und St. Barbara Recruiting
Halle, Sachsen-Anhalt, Germany, 06110
Contact: Sven Seeger, Dr.         
Contact: Yvonne Jäger, Dr.         
Universitätsklinik Halle Recruiting
Halle, Sachsen-Anhalt, Germany, 06120
Contact: Gregor Seliger, Dr.         
Contact: Volker Thäle, Dr.         
Universitätsklinikum Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Matej Komar, Dr.         
Contact: Jennifer L Winkler, Dr.         
Uniklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Anne Tauscher, Dr.         
Contact: Susanne Schrey-Petersen, Dr.         
Universitätsklinikum Schleswig Holstein Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Ulrich Pecks, PD Dr.         
Contact: Christel Eckmann, Prof. Dr.         
Universitätsklinikum Jena Recruiting
Jena, Thüringen, Germany, 07747
Contact: Tanja Groten, PD Dr.         
Contact: Ekkehard Schleußner, Prof. Dr.         
Berlin Charité Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Stefan Verlohren, PD Dr.         
Contact: Wolfgang Henrich, Prof. Dr.         
Berlin Vivantes Klinikum Neukölln Recruiting
Berlin, Germany, 12351
Contact: Wolfgang Schlembach, PD Dr.         
Contact: Babette Ramsauer, Dr.         
Sponsors and Collaborators
Jena University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tanja Groten, PD Dr. Universital Hospital Jena

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT03669185     History of Changes
Other Study ID Numbers: ZKS_0021PETN
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jena University Hospital:
PETN
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes