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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06383624
Study type Observational
Source Benha University
Contact
Status Completed
Phase
Start date April 1, 2023
Completion date March 31, 2024