Respiratory Distress SyndromeNCT06874478
Respiratory Distress and Elective Cesarean Section at Term
An observational study of Respiratory Distress Syndrome, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Ultrasound
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Woman who will be delivered by cesarian section at term
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Woman's Health Hospital - Assiut university
Asyut, 71111
Mohammed K ALi, MD, +201005537951, m_khairy2001@yahoo.com
About this study
Official title: The Rate and Predictors of Respiratory Distress Among Neonates Delivered by 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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Ultrasound
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Women with gestational age ≥ 37 weeks who will be delivered by elective cesarean section | Those women will be subjected to pulmonary artery doppler velocimetery Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry
Measured: 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 May 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874478
- Sponsor's protocol ID
- RD-CS
- Status last verified
- May 2025
- First submitted
- 8 Mar 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rate and Predictors of Respiratory Distress Among Neonates Delivered by Elective Cesarean Section at Term
- ClinicalTrials.gov ID
- NCT06874478
- Acronym / sponsor ID
- RD-CS
- Conditions
- Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with gestational age ≥ 37 weeks who will be delivered by elective cesarean section | – | Diagnostic Test: UltrasoundThose women will be subjected to pulmonary artery doppler velocimetery |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Woman who will be delivered by cesarian section at term
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundThe 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. | Diagnostic test | Women with gestational age ≥ 37 weeks who will be delivered by elective cesarean section |
Primary outcome
the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry
Time frame: 37 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed K Ali, MD (01005537951, m_khairy2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry (time frame: 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.