Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06874478

Respiratory Distress and Elective Cesarean Section at Term

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Woman's Health Hospital - Assiut university

Asyut, 71111, Egypt

Location status: Recruiting

Location contact

Mohammed K ALi, MD

CONTACT

[email protected]

+201005537951

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Diagnostic Test

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. After the optimum fetal main pulmonary artery waveform, Doppler velocity will be manually traced three times, and the average will be taken.

Primary outcomes

  1. the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry

    Time frame: 37 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed K Ali, MD

CONTACT

[email protected]

01005537951

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.