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

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)

• Registration Number: NCT06653374
• Lead Sponsor: HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

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.

Study Timeline

• Study Start: 2023-11-12
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-10
• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-19
• Last Update Submitted: 2024-10-19
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26000

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neonatal Mortality Rate	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Gineco Obstétrico Isidro Ayora; 🇪🇨 Quito, Pichincha, Ecuador