- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443345
Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia
March 9, 2026 updated by: Mina Adolf Helmy, Cairo University
Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia With Severe Features Undergoing Cesarean Delivery: A Prospective Observational Study
Preeclampsia with severe features remains a leading contributor to maternal morbidity and mortality, particularly in low- and middle-income countries.
It is defined by hypertension and involvement of multiple organ systems, including renal, hepatic, hematologic, and neurologic pathways.
The interplay of endothelial dysfunction, capillary leakage, and disrupted fluid balance in these patients increases their susceptibility to perioperative pulmonary complications.
Although respiratory complications in preeclampsia are clinically significant, the true incidence of postoperative diaphragmatic dysfunction in women with severe disease is not well established.
Existing literature largely emphasizes general respiratory failure, pulmonary edema, or the need for mechanical ventilation, rather than specifically evaluating diaphragmatic performance with objective methods such as ultrasound.
The current study sought to determine the incidence and identify risk factors for postoperative diaphragmatic dysfunction in women with severe preeclampsia following cesarean delivery.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mina Adolf Helmy, MD
- Phone Number: 01275716942
- Email: minaadolf1988@cu.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo University Hospitals
-
Contact:
- Mina
-
Contact:
- Mina Adolf Helmy, MD
- Phone Number: 01275716942
- Email: minaadolf1988@cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This prospective observational study will enroll pregnant women aged 20-40 years present to the emergency department with a diagnosis of preeclampsia with severe features and are scheduled for cesarean delivery
Description
Inclusion Criteria:
- Patients with severe preeclampsia undergoing cesarean section
- Gestational age > 32 weeks
Exclusion Criteria:
• Age < 20 years.
- Diabetic
- Patients with neuromuscular diseases.
- Patient refusal.
- Contraindications to magnesium sulphate administration
- Inability to obtain adequate ultrasound views
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Preeclampsia with severe features
diaphragmatic excursion evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of postoperative diaphragmatic dysfunction
Time Frame: Diaphragmatic excursion is measured before and 24 hours after surgery.
|
diaphragmatic dysfunction is defined as a mean diaphragmatic excursion of less than 10 mm
|
Diaphragmatic excursion is measured before and 24 hours after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of change in DE
Time Frame: 24 hours after surgery
|
Percentage of change in diaphragmatic excursion from baseline to 24 hours after surgery
|
24 hours after surgery
|
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Risk factors associated with postoperative diaphragmatic dysfunction
Time Frame: 24 hours after surgery
|
Regression analysis to detect risk factors
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 2, 2026
Study Record Updates
Last Update Posted (Actual)
March 11, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-62-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.