NCT06874478 Respiratory Distress and Elective Cesarean Section at Term
| NCT ID | NCT06874478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assiut University |
| Condition | Respiratory Distress Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 210 participants in total. It began in 2025-05-01 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06874478 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 39 Years, studying Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06874478 currently recruiting?
Yes, NCT06874478 is actively recruiting participants. Contact the research team at m_khairy2001@yahoo.com for enrollment information.
Where is the NCT06874478 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT06874478 clinical trial?
NCT06874478 is sponsored by Assiut University. The trial plans to enroll 210 participants.