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Recruiting NCT06874478

Respiratory Distress and Elective Cesarean Section at Term

Observational Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome. Basic parameters: 20 years — 39 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Rate and Predictors of Respiratory Distress Among Neonates Delivered by Elective Cesarean Section at Term

Overview

Cesarean section is a life-saving surgical operation for women and their newborns. In Egypt, caesarean sections are over-utilized. The rate increased from 27.6 % in 2008 to 51.8 % in 2014, reaching 72.2 % in 2021. Cesarean section has been associated with an increased risk of adverse respiratory outcomes in newborns. Studies have shown a higher risk of neonatal respiratory distress syndrome in babies born by elective cesarean section, especially at 37 and 38 weeks' gestation. Neonatal respiratory distress syndrome is one of the leading causes of neonatal morbidity and mortality. Many non-invasive tools have been used to predict the risk of neonatal respiratory distress syndrome. Most of these studies assessed the predictors of neonatal respiratory distress syndrome in low birth or preterm fetuses, and none of them talked about neonatal respiratory distress syndrome with term fetuses. Doppler velocimetry provides a simple and non-invasive method to assess the fetal pulmonary circulation. Pulmonary Doppler velocimetry is used to determine lung maturity in complicated pregnancies. The magnitude of neonatal respiratory distress syndrome among term neonates depends on the availability of medical services and the number of trained medical personnel. So, there is a need to assess the rate and predictors of eonatal respiratory distress syndrome among low-risk term fetuses delivered by Cesarean section to give attention and appropriate intervention for these predictors to decrease the morbidity and mortality associated with eonatal respiratory distress syndrome.

Interventions

  • Diagnostic test Ultrasound
    The main pulmonary artery will be seen between the pulmonary valve and the bifurcation of the right and left branches. The pulsed Doppler sample gate will be adjusted to 3 mm, and the angle of insonation will be kept at or around 15°. Doppler gain and scale will be tailored for optimizing the velocity waveform display, clearly showing the peak systolic velocity (PSV) and early diastolic notch. The MPA Doppler waveform will show a sharp systolic peak blood flow with a needle-like appearance. Afte

Primary outcome measures

  • the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry [Time frame: 37 weeks]

Eligibility criteria

Inclusion criteria

  • Maternal age of 20-39 years.
  • Women with singleton pregnancy ≥ 37 weeks
  • Pregnant women who received corticosteroid to enhance lung maturity and will be subjected to elective cesarian section (before onset of labour) within 1 week after administration of corticosteroid

Exclusion criteria

  • Women with oligohydramnios or polyhydramnios.
  • Women with underlying disease requiring corticosteroids.
  • Pregnant women with any medical disorders such as hypertension, diabetes, renal diseases, antiphospholipid syndrome, intrauterine growth restriction, preterm premature rupture of membrane, placenta previa, antepartum haemorrhage, on anticoagulant thereby.
  • Women with confirmed fetal malformation.
  • Women who will refuse to participate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Egypt · 1 center
  • Woman's Health Hospital - Assiut university — Asyut

Identifiers

NCT: NCT06874478 · RD-CS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗