Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns (UCE)

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 26000

Contacts and Locations

Study Locations

• Ecuador
  • Pichincha
    • Quito, Pichincha, Ecuador, 170601
      • Hospital Gineco Obstétrico Isidro Ayora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population includes all live-born neonates delivered at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022. The cohort encompasses neonates born to mothers of diverse socioeconomic backgrounds, varying maternal health conditions, and different obstetric risk profiles. The study focuses on evaluating neonatal outcomes based on gestational age, birth weight, and the presence of perinatal complications, such as maternal hypertension, diabetes, or preterm labor. This population represents a high-risk group typical of a tertiary care referral center, allowing for a comprehensive analysis of factors influencing neonatal morbidity and mortality.

Description

Inclusion Criteria:

• Neonates born at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022.
• Live-born neonates with complete medical records in the hospital's perinatal database.
• Neonates whose mothers received antenatal care and delivered at the hospital. Availability of maternal and neonatal data, including gestational age, birth weight, and outcome information.

Exclusion Criteria:

• Neonates with incomplete or missing medical records.
• Neonates born outside the hospital and referred postnatally.
• Stillbirths and pregnancies terminated due to maternal or fetal indications.
• Neonates discharged to other facilities immediately after birth without follow-up data in the hospital's database.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infant, Premature; The "Infant, Premature" group includes neonates born before 37 weeks of gestation at the Isidro Ayora Obstetric-Gynecologic Hospital. This cohort is particularly vulnerable to a range of complications, including respiratory distress syndrome, intraventricular hemorrhage, and infections, which are major contributors to neonatal morbidity and mortality.	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
Neonatal Morbidity and Mortality Cohort; This cohort includes all live-born neonates delivered at the Isidro Ayora Obstetric-Gynecologic Hospital between January 2008 and December 2022. The study focuses on evaluating the influence of various perinatal and neonatal conditions on morbidity and mortality outcomes. Interventions of interest include obstetric management strategies (e.g., use of antenatal corticosteroids, mode of delivery), neonatal resuscitation protocols, NICU admission criteria, and the implementation of specific neonatal care practices such as early surfactant administration, infection control measures, and nutritional support.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Mortality Rate	The proportion of neonates who die within the first 28 days of life out of the total number of live births.	first 28 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Morbidity Incidence	Incidence of major neonatal morbidities, including sepsis, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and perinatal asphyxia.	first 28 days of life

Collaborators and Investigators

• Sponsor: HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
• Collaborators: Universidad Central del Ecuador

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2023
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 19, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Congenital Abnormalities; Infant, Premature; Respiratory Distress Syndrome, Newborn; Infant, Low Birth Weight; Asphyxia Neonatorum; Hypertension, Pregnancy-Induced; Fetal Growth Retardation; Diabetes, Gestational; Placental Abruption; Sepsis, Neonatal; Jaundice, Neonatal; Hypoglycemia, Neonatal; Premature Rupture of Fetal Membranes
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infections; Respiratory Tract Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperbilirubinemia; Skin Manifestations; Death; Fetal Diseases; Growth Disorders; Hyperbilirubinemia, Neonatal; Placenta Diseases; Neonatal Sepsis; Congenital Abnormalities; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Diabetes, Gestational; Eclampsia; Pre-Eclampsia; Fetal Membranes, Premature Rupture; Fetal Growth Retardation; Hypertension, Pregnancy-Induced; Abruptio Placentae; Hypertension; Jaundice, Neonatal; Hypoglycemia; Birth Weight; Jaundice; Asphyxia; Rupture
• Other Study ID Numbers: 009-DOC-FCM-2023 (Other Identifier: Universidad Central del Ecuador)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The database contains sensitive information on neonates and their mothers, protected by ethical and confidentiality regulations. Due to the nature of the data and hospital policies, IPD will not be shared publicly to safeguard patient privacy and comply with local regulations. Aggregated results will be available in scientific publications, but individual data will not be accessible to third parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No