NCT06653374

Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns

"Condiciones Perinatales Que Influyen en la Morbimortalidad y atención Medica en Neonatos Del Hospital Gineco Obstétrico Isidro Ayora, Enero 2008-diciembre 2022"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26,000 (actual)
• Sponsor: HOSPITAL GINECO OBSTETRICO ISIDRO AYORA · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

Summary

This study focuses on understanding the conditions that affect newborn health and survival from pregnancy to the first weeks of life at the Isidro Ayora Hospital. The investigators will review data from 2008 to 2022 to identify key factors that may contribute to complications, help improve medical care, and reduce risks for newborns. By doing so, we aim to provide better support to families, healthcare providers, and ensure safer births.

Detailed description

This research investigates the impact of various perinatal conditions-such as maternal health, prenatal complications, delivery methods, and neonatal management-on morbidity and mortality rates in newborns treated at the Isidro Ayora Obstetric-Gynecologic Hospital. Using a retrospective cohort design, the study analyzes data from 2008 to 2022 to identify patterns and correlations between perinatal factors and neonatal outcomes, aiming to inform evidence-based clinical practices and enhance neonatal care protocols. Key aspects include evaluating the influence of gestational age, birth weight, maternal comorbidities (e.g., hypertension, diabetes), and obstetric complications on the health of neonates. Outcomes of interest include NICU admissions, length of hospital stay, and incidence of conditions such as respiratory distress syndrome, sepsis, and neonatal mortality. Findings will contribute to improving resource allocation, optimizing care strategies, and potentially guiding policy decisions to reduce adverse neonatal outcomes.

Conditions

• Preterm Birth
• Low Birth Weight
• Intrauterine Growth Restriction (IUGR)
• Perinatal Asphyxia
• Neonatal Sepsis
• Respiratory Distress Syndrome (RDS)
• Neonatal Jaundice
• Congenital Malformations
• Neonatal Hypoglycemia
• Gestational Diabetes Mellitus (GDM)
• Placental Abruption
• Preterm Premature Rupture of Membranes (PPROM)
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Interventions

Type	Name	Description
BEHAVIORAL	Infant, Premature	This intervention is distinct as it focuses specifically on observational monitoring and evaluation of neonatal outcomes without applying a therapeutic or procedural treatment. Unlike other interventional studies, the emphasis is on analyzing standard care practices, risk factor exposures (e.g., prematurity, maternal complications), and their impact on neonatal morbidity and mortality. The intervention involves systematic data collection and longitudinal follow-up to identify patterns and associations, rather than introducing new clinical techniques or treatment

Timeline

• Start date: 2023-11-12
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2024-10-22
• Last updated: 2024-10-22

Locations

1 site across 1 country: Ecuador