High Risk PregnancyPhase 1/2NCT01355822
Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
A Phase 1/2 study testing PETN in people with High Risk Pregnancy, run by University of Jena at 1 site in Germany.
Trial summary
Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- PETN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2002to Jan 2008
- Phase
- Phase 1/2
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women 190 to 236 weeks of gestation
- abnormal uterine Doppler as defined by bilateral notching, unilateral notching and increased impedance with mean resistance index (RI) > 0.65 or with mean RI > 0.7 without notching at time of enrollement
- informed consent
Who cannot join
- multiple gestation
- documented chromosomal or major fetal abnormalities
- rupture of membranes and/or clinical chorioamnionitis at time of enrolment
- maternal disease defined as contraindication for intake of PETN
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Jena, Department of Obstetrics
Jena, Thuringia, 07743
About this study
Official title: Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study
Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.
The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.
- Conditions
- High Risk Pregnancy
- Being tested
- PETN, Placebo control
- Keywords
- abortion, perinatal death, IUGR, preterm birth, placental abruption, preeclampsia
- Medical subject headings
- Perinatal Death, Premature Birth, Abruptio Placentae, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETNDrug
Also called Pentalong®, , Actavis Germany, Langenfeld, Germany
Pentaerythrithyltetranitrate: 80 mg orally twice a day
Placebo controlDrug
orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo control |
| PETN | Experimental | Pentalong, Actavis Germay: 80 mg twice a day Receives: Drug: PETN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
Measured: 19 -40 weeks of gestation
Secondary outcomes (4)
Development of IUGR and severe IUGR defined as birth weight below the 5th percentile
Measured: 19-40 weeks of gestation
Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation
Measured: 19 - 32 weeks of gestation
Development of preeclampsia
Measured: 19 - 40 weeks of gestation
Any form of placental abruption
Measured: 19 - 40 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startApr 2002
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355822
- Sponsor's protocol ID
- PETN_ESTG
- Status last verified
- May 2011
- First submitted
- 16 May 2011
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01355822
- Acronym / sponsor ID
- PETN_ESTG
- Conditions
- High Risk Pregnancy
- Keywords
- abortion, perinatal death, IUGR, preterm birth, placental abruption, preeclampsia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Jan 2008 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.
The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo control |
| PETN | Experimental | Drug: PETNPentalong, Actavis Germay: 80 mg twice a day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant women 190 to 236 weeks of gestation
- abnormal uterine Doppler as defined by bilateral notching, unilateral notching and increased impedance with mean resistance index (RI) > 0.65 or with mean RI > 0.7 without notching at time of enrollement
- informed consent
Key exclusion criteria (4 listed)
- multiple gestation
- documented chromosomal or major fetal abnormalities
- rupture of membranes and/or clinical chorioamnionitis at time of enrolment
- maternal disease defined as contraindication for intake of PETN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PETNAlso: Pentalong®, , Actavis Germany, Langenfeld, GermanyPentaerythrithyltetranitrate: 80 mg orally twice a day | Drug | PETN |
| Placebo controlorally, twice daily | Drug | Placebo |
Primary outcome
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
Time frame: 19 -40 weeks of gestation
4 secondary outcomes
Development of IUGR and severe IUGR defined as birth weight below the 5th percentile
Time frame: 19-40 weeks of gestation
Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation
Time frame: 19 - 32 weeks of gestation
Development of preeclampsia
Time frame: 19 - 40 weeks of gestation
Any form of placental abruption
Time frame: 19 - 40 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PETN in people with High Risk Pregnancy, run by University of Jena at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile (time frame: 19 -40 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2011; AzTrials last refreshed its copy on 8 Nov 2026.