Clinical trial NCT06653374: Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns
Official title: "Condiciones Perinatales Que Influyen en la Morbimortalidad y atención Medica en Neonatos Del Hospital Gineco Obstétrico Isidro Ayora, Enero 2008-diciembre 2022"
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
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
Lead sponsor: HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
Sponsor class: OTHER
Collaborators: name: Universidad Central del Ecuador
First posted: 2024-10-22
Enrollment: 26000
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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\&#39;s database.

Primary outcomes:
measure: Neonatal Mortality Rate
timeFrame: first 28 days of life
Secondary outcomes:
measure: Neonatal Morbidity Incidence
timeFrame: first 28 days of life
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Hospital Gineco Obstétrico Isidro Ayora
state: Pichincha
Study officials:
References: