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Clinical Trials/NCT06383624
NCT06383624CompletedNot Applicable

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

Benha University1 site in 1 country115 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
115
Locations
1
Primary Endpoint
Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Minute to 6 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Apparently normal singleton pregnancies with gestational age ≥37 weeks who will be underwent a scheduled elective cesarean section under spinal anesthesia.

Exclusion Criteria

  • Multiple pregnancies.
  • Gestational age < 37 weeks.
  • Neonates with congenital anomalies.
  • Maternal exposure to antenatal steroids
  • Mothers with medical problems as gestational or chronic diabetes mellitus and pregnancy induced hypertension or chronic hypertension.
  • Induced or spontaneous onset of labor.
  • Combined spinal-epidural anesthetic during which epidural activation is necessary before delivery .

Outcomes

Primary Outcomes

Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery

Time Frame: 6 hours after delivery

We will evaluate the association between transient tachypnea of newborns development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery

Association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery

Time Frame: 1 hour after delivery

we will evaluate the association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amany Mohammed El-Rebigi, MD

Lecturer of Pediatric and Neonatology

Benha University

Study Sites (1)

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