CClinicalTrials.gg
RecruitingNCT06874478Updated May 28, 2025

Respiratory Distress and Elective Cesarean Section at Term

An observational study in Respiratory Distress Syndrome, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
210
Ages
20 Years to 39 Years
Sex
Female
01

Study 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.

02

Conditions studied

03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 210 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Woman who will be delivered by cesarian section at term

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

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.
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
210 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testUltrasound

    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.

06

What researchers measure

Primary outcomes

  1. the rate of neonatal respiratory distress syndrome by pulmonary artery velocimetry

    Time frame: 37 weeks

07

Study locations

1 of 1 sites recruiting
  • Woman's Health Hospital - Assiut university
    Assiut, 71111, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06874478
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Professor, Assiut University) — Principal investigator
First posted
Mar 13, 2025
Start date
May 1, 2025
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 28, 2025

Study contacts

Mohammed K Ali, MD
Contact
m_khairy2001@yahoo.com
01005537951

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion