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RecruitingNCT07443345Updated Mar 11, 2026

Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia

An observational study in Preecalmpsia, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Preecalmpsia

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Keywords

  • preeclampsia
  • Diaphragmatic dysfunction
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 52 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
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

Inclusion criteria

  • Patients with severe preeclampsia undergoing cesarean section
  • Gestational age > 32 weeks

Exclusion criteria

Exclusion Criteria:

    • Age \< 20 years.

      • Diabetic
      • Patients with neuromuscular diseases.
      • Patient refusal.
      • Contraindications to magnesium sulphate administration
      • Inability to obtain adequate ultrasound views
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • Preeclampsia with severe features

    diaphragmatic excursion evaluation

06

What researchers measure

Primary outcomes

  1. The incidence of postoperative diaphragmatic dysfunction

    diaphragmatic dysfunction is defined as a mean diaphragmatic excursion of less than 10 mm

    Time frame: Diaphragmatic excursion is measured before and 24 hours after surgery.

Secondary outcomes

  1. Percentage of change in DE

    Percentage of change in diaphragmatic excursion from baseline to 24 hours after surgery

    Time frame: 24 hours after surgery

  2. Risk factors associated with postoperative diaphragmatic dysfunction

    Regression analysis to detect risk factors

    Time frame: 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
  • Cairo University Hospitals
    Cairo, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07443345
Lead sponsor
Cairo University
Responsible party
Mina Adolf Helmy (Doctor, Cairo University) — Principal investigator
First posted
Mar 2, 2026
Start date
Mar 9, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 11, 2026

Study contacts

Mina Adolf Helmy, MD
Contact
minaadolf1988@cu.edu.eg
01275716942

Oversight

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

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