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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06653374
Acronym
UCE
Enrollment
26000
Registered
2024-10-22
Start date
2023-11-12
Completion date
2024-09-10
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Infant, Premature, Infant, Low Birth Weight, Fetal Growth Retardation, Asphyxia Neonatorum, Sepsis, Neonatal, Respiratory Distress Syndrome, Newborn, Jaundice, Neonatal, Congenital Abnormalities, Hypoglycemia, Neonatal, Hypertension, Pregnancy-Induced, Diabetes, Gestational, Placental Abruption, Premature Rupture of Fetal Membranes

Brief 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.

Interventions

BEHAVIORALInfant, 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

Sponsors

Universidad Central del Ecuador
CollaboratorOTHER
HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Mortality Ratefirst 28 days of lifeThe proportion of neonates who die within the first 28 days of life out of the total number of live births.

Secondary

MeasureTime frameDescription
Neonatal Morbidity Incidencefirst 28 days of lifeIncidence of major neonatal morbidities, including sepsis, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and perinatal asphyxia.

Countries

Ecuador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026