Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03669185
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2018-08-28
Brief Title:
Pentaerithrityl Tetranitrate PETN for Secondary Prevention of Intrauterine Growth Restriction
Sponsor:
Jena University Hospital
Organization:
Jena University Hospital
Study Overview
Official Title:
Pentaerithrityltetranitrat PETN Zur Sekundärprophylaxe Der Intrauterinen Wachstumsretardierung
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PETN
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
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 RR0609 95 CI 0367 to 1011 for the development of IUGR and IUGR or death RR0615 95 CI 0378 to 1000 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 16 singleton pregnancy informed consent and 190 to 226 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
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 16 singleton pregnancy informed consent and 190 to 226 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None