Impact of elective cesarean sections on newborn respiratory distress

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

This study looks at whether having an elective cesarean section affects the chances of newborns having breathing problems, specifically for pregnant women aged 20-39 who are at least 37 weeks along and have received treatment to help their baby's lungs.

Quick facts

• Study type: Observational
• Enrollment: 210 (estimated)
• Ages: 20 Years to 39 Years
• Sex: Female
• Sponsor: Assiut University (Academic / other)
• Locations: 1 site (Asyut)
• Trial ID: NCT06874478 on ClinicalTrials.gov

What this trial studies

This observational study examines the relationship between elective cesarean sections and the incidence of respiratory distress syndrome in newborns. It focuses on pregnant women aged 20-39 years with singleton pregnancies at or beyond 37 weeks of gestation who have received corticosteroids to enhance lung maturity. The study utilizes Doppler velocimetry, a non-invasive ultrasound method, to assess fetal pulmonary circulation and predict respiratory outcomes. The goal is to better understand the risks associated with elective cesarean deliveries in term pregnancies.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 20-39 years with singleton pregnancies at or beyond 37 weeks who have received corticosteroids.

Not a fit: Patients with underlying medical conditions or fetal malformations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved guidelines for elective cesarean sections, potentially reducing the incidence of respiratory distress in newborns.

How similar studies have performed: While there have been studies on respiratory distress in preterm infants, this specific focus on term infants following elective cesarean sections is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Maternal age of 20-39 years.
2. Women with singleton pregnancy ≥ 37 weeks
3. 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:

1. Women with oligohydramnios or polyhydramnios.
2. Women with underlying disease requiring corticosteroids.
3. 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.
4. Women with confirmed fetal malformation.
5. Women who will refuse to participate.

Where this trial is running

Asyut

• Woman's Health Hospital - Assiut university — Asyut, Egypt (Recruiting)

Study contacts

• Study coordinator: Mohammed K Ali, MD

Conditions Respiratory Distress Syndrome