AzTrials
AzTrials

Fetal Growth RetardationPhase 3PETNNCT03669185

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

A Phase 3 study testing Pentalong in people with Fetal Growth Retardation and Pregnancy Related, run by Jena University Hospital at 14 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pentalong
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
14 sitesGermany
Study dates
26 Jul 2017to 31 Oct 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Berlin Charité Campus Mitte

    Berlin, 10117

  • Berlin Vivantes Klinikum Neukölln

    Berlin, 12351

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, Saxony-Anhalt, 06110

  • Universitätsklinik Halle

    Halle, Saxony-Anhalt, 06120

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Universitätsklinikum Schleswig Holstein

    Kiel, Schleswig-Holstein, 24105

  • Uniklinikum Leipzig

    Leipzig, Saxony, 04103

  • Klinikum der Universität München

    München, Bavaria, 81377

  • Städtisches Klinikum München

    München, Bavaria, 81545

  • Universitäts-Frauenklinik Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

About this study

Official title: Pentaerithrityltetranitrat (PETN) Zur Sekundärprophylaxe Der Intrauterinen Wachstumsretardierung

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.

Read the 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.

Being tested
Pentalong, Placebos
Keywords
PETN
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PentalongDrug

    Also called Pentaeritrithyl tetranitrate, Pentalong® 50 mg

    Pentalong, 2 x daily 1 tablet, intake max. 133 days

  • PlacebosDrug

    Placebos, 2 x daily 1 tablet, intake max. 133 days

Study groups in NCT03669185
Study groupRoleWhat they receive
PlacebosPlacebo comparatorPlacebos, 2 times daily 1 tablet, intake max. 133 days
Receives: Drug: Placebos
PentalongActive comparatorPentalong, 2 times daily 1 tablet, intake max. 133 days
Receives: Drug: Pentalong

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who develop intrauterine/fetal growth restriction or perinatal death.

    Efficiency of PETN to prevent the development of intrauterine/fetal growth restriction or perinatal death.

    Measured: 19 weeks of pregnancy - seventh day of life

Secondary outcomes (7)

  1. severe morbidity

    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

    Measured: 19 weeks of pregnancy - seventh day of life

  2. birth weight

    percentage of children with birth weight below the 3rd, 5th or 10th percentile

    Measured: 19-40 weeks of pregnancy

  3. Number of participants who developed FGR

    Number of participants who developed FGR, which necessitates delivery before 30 and 34 week of gestation

    Measured: 19-40 weeks of pregnancy

  4. admission to NICU

    rate of newborns transferred to neonatal intensive care unit

    Measured: Birth to discharge from the hospital

  5. infant outcome

    rate of newborns with intraventricular cerebral haemorrhage (grade II - IV) or necrotizing enterocolitis, b.o.

    Measured: birth to discharge from NICU

  6. number of premature deliveries

    number of premature deliveries before completed 34 and 37 weeks of gestation

    Measured: 19 to 37 weeks of gestation

  7. mortality

    number of perinatal deaths

    Measured: 19 weeks of pregnancy - seventh day of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2018
  2. Study start26 Jul 2017
  3. Primary completion31 Jul 2020
  4. Study completion31 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03669185
Sponsor's protocol ID
ZKS_0021PETN
Acronym
PETN
Status last verified
Feb 2021
First submitted
28 Aug 2018
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Groten T, Lehmann T, Stadtler M, Komar M, Winkler JL, Condic M, Strizek B, Seeger S, Jager Y, Pecks U, Eckmann-Scholz C, Kagan KO, Hoopmann M, von Kaisenberg CS, Hertel B, Tauscher A, Schrey-Petersen S, Friebe-Hoffmann U, Lato K, Hubener C, Delius M, Verlohren S, Sroka D, Schlembach D, de Vries L, Kraft K, Seliger G, Schleussner E; PETN study group. Pentaerythrityl tetranitrate improves the outcome of children born to mothers with compromised uterine perfusion-12-months follow-up and safety data of the double-blind randomized PETN trial. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101332. doi: 10.1016/j.ajogmf.2024.101332. Epub 2024 Mar 7.

    PubMed 38460823

  • Groten T, Lehmann T, Schleussner E; PETN Study Group. Does Pentaerytrithyltetranitrate reduce fetal growth restriction in pregnancies complicated by uterine mal-perfusion? Study protocol of the PETN-study: a randomized controlled multicenter-trial. BMC Pregnancy Childbirth. 2019 Sep 14;19(1):336. doi: 10.1186/s12884-019-2456-7.

    PubMed 31521118

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pentalong in people with Fetal Growth Retardation and Pregnancy Related, run by Jena University Hospital at 14 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who develop intrauterine/fetal growth restriction or perinatal death. (time frame: 19 weeks of pregnancy - seventh day of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03669185, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in