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

HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

Status: Completed

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

Treatments: Behavioral: Infant, Premature

Study type: Observational

Funder types: Other

Identifiers

NCT06653374

009-DOC-FCM-2023 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26,000 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

26,000 participants in 2 patient groups

Infant, Premature

Description:

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.

Treatment:

Behavioral: Infant, Premature

Neonatal Morbidity and Mortality Cohort

Description:

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.

Treatment:

Behavioral: Infant, Premature