Respiratory Distress and Elective Cesarean Section at Term

NCT06874478 | Recruiting

• 1 other identifier: RD-CS
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry

  37 weeks

Study Arms (1)

Women with gestational age ≥ 37 weeks who will be delivered by elective cesarean section

Those women will be subjected to pulmonary artery doppler velocimetery

Diagnostic Test: Ultrasound

Interventions

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.

Women with gestational age ≥ 37 weeks who will be delivered by elective cesarean section

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Woman who will be delivered by cesarian section at term

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Woman's Health Hospital - Assiut university

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Mohammed K Ali, MD

CONTACT

01005537951; m_khairy2001@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)