Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis

NCT ID: NCT06383624

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-03-31

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.

Conditions

Transient Tachypnea of Newborn and Fetal Acidosis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

1. - Multiple pregnancies.

2. - Gestational age < 37 weeks.

3. - Neonates with congenital anomalies.

4. - Maternal exposure to antenatal steroids

5. - Mothers with medical problems as gestational or chronic diabetes mellitus and pregnancy induced hypertension or chronic hypertension.

6. - Induced or spontaneous onset of labor.

7. - Combined spinal-epidural anesthetic during which epidural activation is necessary before delivery .

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Amany Mohammed El-Rebigi, MD

Lecturer of Pediatric and Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amany M. El-Rebigi, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer of pediatric and neonatology, Faculty of medicine, Benha University, Egypt

Locations

Benha University Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

RC18-4-2023

Identifier Type: -

Identifier Source: org_study_id