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NCT Number: NCT07443345

Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University Hospitals

Cairo, Egypt

Location status: Recruiting

Location contact

Mina

CONTACT

Mina Adolf Helmy, MD

CONTACT

[email protected]

01275716942

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of change in DE

    Time frame: 24 hours after surgery

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

  2. Risk factors associated with postoperative diaphragmatic dysfunction

    Time frame: 24 hours after surgery

    Regression analysis to detect risk factors

Study contacts

Contact information is provided by the study sponsor or research team.

Mina Adolf Helmy, MD

CONTACT

[email protected]

01275716942

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia With Severe Features Undergoing Cesarean Delivery: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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