Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-28 @ 9:44 AM
Study NCT ID:
NCT04364932
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2020-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_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:
None
Brief Summary:
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs notwithstanding. In recent years have attempted to quantify the effect, and wider impact of intrapartum compromise, as well as the underlying mechanisms for it. After a poor outcome related to intrapartum care parents and healthcare practitioners often strive to understand whether the event could have been predicted and/or prevented. This can be difficult to answer, at least partly related to the heterogeneous fetal response to perinatal asphyxia. Mothers and the maternity service are increasingly encouraged to personalize care and their choices around the birth process, however the information required to guide these choices is most often missing. This makes it difficult for women and professionals to make an informed choice about their care, including the safest mode of birth for them and their baby.
Aim of the study: Identifying antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Aim of the study: Identifying antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Detailed Description:
Antenatal, perinatal and postpartum data will be documented from the medical notes and from parental reports including;
* Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births)
* Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant)
* Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes).
* Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity.
* Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.
Data will be processed and analyzed using SPSS software and the results will be processed in tables and figures.
* Booking factors (maternal age, smoking, parity, previous lower segment caesarean section (LSCS), multiple births)
* Antenatal factors (preeclampsia, gestational diabetes, prelabor abruption, placenta previa, oligohydramnios, polyhydramnios, threatened preterm labor, gender, concerns of IUGR infant)
* Labor factors (induction of labor, pre-labor rupture of membranes, planned LSCS, gestation at birth, presentation, prelabor breech, breech delivery, duration of ruptured membranes).
* Infant characteristics included GA, gender, birth weight (BW), head circumference, and multiplicity.
* Clinical signs, examination findings and laboratory data also will be included. Most covariates will be extracted from patient's notes, routine data collection or as part of a routine clinical database.
Data will be processed and analyzed using SPSS software and the results will be processed in tables and figures.
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?: