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Completed

NCT Number: NCT06653374

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

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.

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Key information

Conditions

Preterm Birth Abruptio Placentae Asphyxia Neonatorum Cardiovascular Diseases Congenital Abnormalities Congenital Malformations Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Fetal Membranes, Premature Rupture Gestational Diabetes Mellitus (GDM) Glucose Metabolism Disorders Growth Disorders Hyperbilirubinemia Hyperbilirubinemia, Neonatal Hypertension Hypertension, Pregnancy-Induced Hypoglycemia Infant, Newborn, Diseases Infant, Premature, Diseases Infections Inflammation Intrauterine Growth Restriction (IUGR) Jaundice, Neonatal Low Birth Weight Lung Diseases Metabolic Diseases Neonatal Hypoglycemia Neonatal Jaundice Neonatal SEPSIS Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Asphyxia Placenta Diseases Placental Abruption Pre-Eclampsia Pregnancy Complications Premature Birth Preterm Premature Rupture of Membranes (PPROM) Preterm Premature Rupture of the Membranes Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Vascular Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Gineco Obstétrico Isidro Ayora

Quito, Pichincha, 170601, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infant, Premature

Behavioral

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

Primary outcomes

  1. Neonatal Mortality Rate

    Time frame: first 28 days of life

    The proportion of neonates who die within the first 28 days of life out of the total number of live births.

Secondary outcomes

  1. Neonatal Morbidity Incidence

    Time frame: first 28 days of life

    Incidence of major neonatal morbidities, including sepsis, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and perinatal asphyxia.

Sponsors and collaborators

Lead sponsor

HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

Other

Collaborators

  • Universidad Central del Ecuador

Registry information

Official study title

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

Acronym: UCE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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