Clinical trial NCT06874478: Respiratory Distress and Elective Cesarean Section at Term
Official title: The Rate and Predictors of Respiratory Distress Among Neonates Delivered by Elective Cesarean Section at Term
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Distress Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 210
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman who will be delivered by cesarian section at term

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.


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.

Primary outcomes:
measure: the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry
timeFrame: 37 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health Hospital - Assiut university
Study officials:
References: