Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383624
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-21
Brief Title:
Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis
Sponsor:
Benha University
Organization:
Benha University
Study Overview
Official Title:
Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis A Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
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:
We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
Detailed Description:
Transient tachypnea of the newborn TTN is characterized by mild to moderate respiratory distress that is a common self-limited disease of term newborns which gradually improves during the first 48 to 72 hours of life TTN results from failure of the newborn to effectively clear the fetal lung fluid soon after birth
It requires admission to the neonatal intensive care unit which leads to maternal-infant separation the need for respiratory support extended unnecessary exposure to antibiotics prolonged hospital stays and increased health care costs
Furthermore these term neonates are at higher risk for inpatient admission for respiratory syncytial virus bronchiolitis in infancy and reactive airway disease later in life
Transient tachypnea of newborns is 2- to 6-fold more common during elective cesarean delivery compared to vaginal birth
Although the maternal-fetal risk factors for transient tachypnea of newborns are well understood preoperative factors especially in the setting of elective cesarean delivery remain poorly investigated
Significant maternal hypotension is a frequent complication of spinal anesthesia during caesarean delivery However spinal anesthesia is still the preferred anesthetic technique for cesarean delivery due to multiple factors such as avoiding risk of aspiration associated with general anesthetic maternal ability to witness the birth of the baby and higher neonatal APGAR scores
To our knowledge no study has explored the potential role of maternal hemodynamic parameters during neuraxial anesthesia and effect of anesthesia to delivery time at scheduled cesarean delivery in the development of transient tachypnea of newborns and fetal acidosis in Egypt Therefore we hypothesized that pre-delivery maternal spinal anesthesia induced hypotension and anesthesia to delivery time would be associated with transient tachypnea of newborns and fetal acidosis in fullterm neonates delivered by elective cesarean section
To test this hypothesis we performed a prospective observational cohort study to evaluate the association of degree and duration of maternal hypotension and anesthesia to delivery time with development of transient tachypnea of newbon and fetal acidosis
It requires admission to the neonatal intensive care unit which leads to maternal-infant separation the need for respiratory support extended unnecessary exposure to antibiotics prolonged hospital stays and increased health care costs
Furthermore these term neonates are at higher risk for inpatient admission for respiratory syncytial virus bronchiolitis in infancy and reactive airway disease later in life
Transient tachypnea of newborns is 2- to 6-fold more common during elective cesarean delivery compared to vaginal birth
Although the maternal-fetal risk factors for transient tachypnea of newborns are well understood preoperative factors especially in the setting of elective cesarean delivery remain poorly investigated
Significant maternal hypotension is a frequent complication of spinal anesthesia during caesarean delivery However spinal anesthesia is still the preferred anesthetic technique for cesarean delivery due to multiple factors such as avoiding risk of aspiration associated with general anesthetic maternal ability to witness the birth of the baby and higher neonatal APGAR scores
To our knowledge no study has explored the potential role of maternal hemodynamic parameters during neuraxial anesthesia and effect of anesthesia to delivery time at scheduled cesarean delivery in the development of transient tachypnea of newborns and fetal acidosis in Egypt Therefore we hypothesized that pre-delivery maternal spinal anesthesia induced hypotension and anesthesia to delivery time would be associated with transient tachypnea of newborns and fetal acidosis in fullterm neonates delivered by elective cesarean section
To test this hypothesis we performed a prospective observational cohort study to evaluate the association of degree and duration of maternal hypotension and anesthesia to delivery time with development of transient tachypnea of newbon and fetal acidosis
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