PreecalmpsiaNCT07443345
Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia
An observational study of Preecalmpsia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preecalmpsia
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Mar 2026to 31 Dec 2026
- 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 40 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- Patients with severe preeclampsia undergoing cesarean section
- Gestational age > 32 weeks
Who cannot join
- • Age < 20 years.
- Diabetic
- Patients with neuromuscular diseases.
- Patient refusal.
- Contraindications to magnesium sulphate administration
- Inability to obtain adequate ultrasound views
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
Cairo University Hospitals
Cairo
Mina Adolf Helmy, MD, 01275716942, minaadolf1988@cu.edu.eg
Mina
About this study
Official title: 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.
- Conditions
- Preecalmpsia
- Keywords
- preeclampsia, Diaphragmatic dysfunction
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia with severe features | diaphragmatic excursion evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative diaphragmatic dysfunction
diaphragmatic dysfunction is defined as a mean diaphragmatic excursion of less than 10 mm
Measured: Diaphragmatic excursion is measured before and 24 hours after surgery.
Secondary outcomes (2)
Percentage of change in DE
Percentage of change in diaphragmatic excursion from baseline to 24 hours after surgery
Measured: 24 hours after surgery
Risk factors associated with postoperative diaphragmatic dysfunction
Regression analysis to detect risk factors
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start9 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreecalmpsiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443345
- Sponsor's protocol ID
- N-62-2026
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia With Severe Features Undergoing Cesarean Delivery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07443345
- Acronym / sponsor ID
- N-62-2026
- Conditions
- Preecalmpsia
- Keywords
- preeclampsia, Diaphragmatic dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia with severe features | – | –diaphragmatic excursion evaluation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- Patients with severe preeclampsia undergoing cesarean section
- Gestational age > 32 weeks
Key exclusion criteria (6 listed)
- • Age < 20 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Percentage of change in DE
Time frame: 24 hours after surgery
Risk factors associated with postoperative diaphragmatic dysfunction
Time frame: 24 hours after surgery
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 11 Mar 2026.
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 Preecalmpsia, run by Cairo 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 2 inclusion and 6 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 11 Mar 2026. 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 Mina Adolf Helmy, MD (01275716942, minaadolf1988@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative diaphragmatic dysfunction (time frame: Diaphragmatic excursion is measured before and 24 hours after surgery.). 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 11 Mar 2026.