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Clinical Trials/NCT04364932
NCT04364932
Unknown
Not Applicable

Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy

Assiut University0 sites100 target enrollmentSeptember 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Hypoxic Ischemic Encephalopathy
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2021
End Date
December 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Radwa Rady Ali

Resident doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Clinical signs of neonatal encephalopathy(e.g. irritability, decreased responsiveness, coma, seizures, hypotonia, abnormal primitive reflexes, apnea, feeding disturbance, and abnormal cry), NICU admission, full-term infant with poor condition at birth (5-minute Apgar score \<7) and/or need for major resuscitation.

Exclusion Criteria

  • Preterm infant, full term infants with birth asphyxia but with congenital malformations or chromosomal abnormalities, infant of diabetic mother and CNS infections are excluded from the study.

Outcomes

Primary Outcomes

Antenatal and intrapartum risk factors associated with neonatal hypoxic ischemic encephalopathy.

Time Frame: Baseline

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.

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