NCT03669185

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2017

Typical duration for phase_3

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

August 28, 2018

Last Update Submit

February 23, 2021

Conditions

Fetal Growth RetardationPregnancy RelatedIntrauterine Growth Restriction

Keywords

PETN

Outcome Measures

Primary Outcomes (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.

    19 weeks of pregnancy - seventh day of life

Secondary Outcomes (7)

  • severe morbidity

    19 weeks of pregnancy - seventh day of life

  • birth weight

    19-40 weeks of pregnancy

  • Number of participants who developed FGR

    19-40 weeks of pregnancy

  • admission to NICU

    Birth to discharge from the hospital

  • infant outcome

    birth to discharge from NICU

  • +2 more secondary outcomes

Study Arms (2)

Placebos

PLACEBO COMPARATOR

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

Drug: Placebos

Pentalong

ACTIVE COMPARATOR

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

Drug: Pentalong

Interventions

PentalongDRUG

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

Also known as: Pentaeritrithyl tetranitrate, Pentalong® 50 mg
Pentalong
PlacebosDRUG

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

Placebos

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women between pregnancy week 19+0 and 22+6
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Universitäts-Frauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Klinikum der Universität München

München, Bavaria, 81377, Germany

Location

Städtisches Klinikum München

München, Bavaria, 81545, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitätsklinikum Dresden

Dresden, Saxony, 01307, Germany

Location

Uniklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Krankenhaus St. Elisabeth und St. Barbara

Halle, Saxony-Anhalt, 06110, Germany

Location

Universitätsklinik Halle

Halle, Saxony-Anhalt, 06120, Germany

Location

Universitätsklinikum Schleswig Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Berlin Charité Campus Mitte

Berlin, 10117, Germany

Location

Berlin Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Related Publications (2)

  • 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.

    PMID: 38460823DERIVED

  • 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.

    PMID: 31521118DERIVED

Related Links

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tanja Groten, PD Dr.

    Universital Hospital Jena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 13, 2018

Study Start

July 26, 2017

Primary Completion

July 31, 2020

Study Completion

October 31, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

DE(14)