Obstetric ComplicationPOLUSNCT06728709
Lung Ultrasound in Critically Ill Obstetrics and Gynecological Patients
An observational study of Obstetric Complication and Gynecologic Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pulmonary dysfunction aggravates the illness of critically ill obstetrics and gynecological patients. Early identification with bedside technique and prompt management may improve the outcome of critical care in this vulnerable population Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetric Complication, Gynecologic Cancer, Lung Diseases
- What is being tested?
- ultrasound detection of any abnormal ultrasonographical findings.
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 11 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: critically ill women admitted in the ICU for any medical, obstetric, or surgical causes.
Who may be able to join
- Any patient admitted to the obstetrics and gynecology intensive care unit
Who cannot join
- Patient's refusal
- inability to do a lung ultrasound examination during the first 24 hours of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Lung Ultrasound Phenotypes and Clinical Outcomes in Critically Ill Obstetrics and Gynaecologic Patients (POLUS): A Prospective Cohort Study
Pulmonary dysfunction aggravates the illness of critically ill obstetrics and gynecological patients. Early identification with bedside technique and prompt management may improve the outcome of critical care in this vulnerable population
Read the detailed description
Hormonal changes in a woman's menstrual cycle and changes during pregnancy affect the respiratory system. These changes especially during pregnancy and peripartum complicate the critical care management of the female patients. In addition to the effect of different pregnancy-related as sepsis, and preeclampsia which directly or indirectly predispose to pulmonary complications.
The presence of difficulty in the transfer of critically ill patients mandates point of care modality. Avoidance of fetal exposure to hazardous radiation demands safe technology. Ultrasound arises as a screening method that can be performed rapidly and enables healthcare providers to make timely decisions with no radiation exposure. Thus it facilitates the management of critically ill obstetric and gynecological patients.
When compared to other imaging techniques; X-ray imaging is preferably restricted in parturient because of the ionizing risk on the fetus, and CT is not feasible in critically ill if there is a risk of transfer. Thus ultrasound emerged as a bedside imaging technique.
Yet, the prevalence of the specific ultrasound signatures in that population is not clearly defined and its relation to poor outcome was not tested, This trial is the first trial to determine frequency, timing concerning admission, type of pulmonary abnormalities detectable by LUS, and their associations with poor outcome in patients whether obstetrics or gynecology admitted to the ICU specialized in women's intensive care
- Conditions
- Obstetric Complication, Gynecologic Cancer, Lung Diseases, Ultrasound
- Being tested
- ultrasound detection of any abnormal ultrasonographical findings.
- Keywords
- lung ultrasound, critically ill peripartum, critically ill gynecological cases
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound detection of any abnormal ultrasonographical findings.Diagnostic test
ultrasound assessment within 24 hours. Then reassessment every 48 hours or when the patient develops respiratory distress.
While the patient is in a supine or semi-recumbent position, and the probe is in a short axis. The 8-region technique will be used. The areas are four on each side of the chest. The examiner will assess 8 regions -Anterior chest wall ( ACW), Anterior axillary line (AAXL), costo-phrenic angle (COSTO), Postero-lateral alveolar \&/ or pleural syndrome (PLAPS) right and left . Each region will be scored using the LUS aeration score. as follows: "0," A-pattern with 0-2 B-lines; "1," more than 2 separated B-lines; "2," multiple coalescent B-lines; or "3," lung consolidation, . A global LUS score will be calculated at each time point and range from 0 to 24.
posterior region will be assessed if needed and if feasible. The venous status will be assessed through a subcostal view for inferior vena cava diameter.
| Study group | Role | What they receive |
|---|---|---|
| obstetrics critically ill | critically ill obstetrics patients admitted yo ICU for any cause during pregnancy or postpartum. Receives: Diagnostic Test: ultrasound detection of any abnormal ultrasonographical findings. | |
| gynecological critically ill patients | gynecological cases admitted to ICU for any cause of medical or postoperative care Receives: Diagnostic Test: ultrasound detection of any abnormal ultrasonographical findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Prevalence of different ultrasonographical abnormal lung signatures
presence or absence of us abnormalities as: abnormal sliding, interstitial syndrome, consolidation, cavitation, pleural effusion, or collapse
Measured: From date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 days
Secondary outcomes (2)
correlation of ultrasonographic finding with mortality or poor outcome
frequency of occurrence of poor outcomes -mortality or ventilatory support- for every abnormal lung ultrasonographic signature.
Measured: from the appearance of abnormal ultrasonographic signature to death or disharge from ICU which comes first , assessed up to 20 days from the day of admission
timing of appearance of abnormal ultrasonography lung signatures
the time of detection of the abnormal lung ultrasonographic finding
Measured: on admission, after every 48 hours during ICU stay till death or dischrage from ICU which comes first, assessed up to 20 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024
- Primary completion1 Jul 2026
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wessam selima, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728709
- Sponsor's protocol ID
- FMASU R148/2024
- Acronym
- POLUS
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rocca E, Zanza C, Longhitano Y, Piccolella F, Romenskaya T, Racca F, Savioli G, Saviano A, Piccioni A, Mongodi S. Lung Ultrasound in Critical Care and Emergency Medicine: Clinical Review. Adv Respir Med. 2023 May 17;91(3):203-223. doi: 10.3390/arm91030017.
PubMed 37218800Pisani L, De Nicolo A, Schiavone M, Adeniji AO, De Palma A, Di Gennaro F, Emuveyan EE, Grasso S, Henwood PC, Koroma AP, Leopold S, Marotta C, Marulli G, Putoto G, Pisani E, Russel J, Serpa Neto A, Dondorp AM, Hanciles E, Koroma MM, Schultz MJ. Lung Ultrasound for Detection of Pulmonary Complications in Critically Ill Obstetric Patients in a Resource-Limited Setting. Am J Trop Med Hyg. 2020 Dec 14;104(2):478-486. doi: 10.4269/ajtmh.20-0996.
PubMed 33319731
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Lung Ultrasound Phenotypes and Clinical Outcomes in Critically Ill Obstetrics and Gynaecologic Patients (POLUS): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06728709
- Acronym / sponsor ID
- POLUS / FMASU R148/2024
- Conditions
- Obstetric Complication, Gynecologic Cancer, Lung Diseases, Ultrasound
- Keywords
- lung ultrasound, critically ill peripartum, critically ill gynecological cases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 11 Jul 2026 (actual)
- First posted
- 11 Dec 2024 (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.
Pulmonary dysfunction aggravates the illness of critically ill obstetrics and gynecological patients. Early identification with bedside technique and prompt management may improve the outcome of critical care in this vulnerable population
Detailed description
Hormonal changes in a woman's menstrual cycle and changes during pregnancy affect the respiratory system. These changes especially during pregnancy and peripartum complicate the critical care management of the female patients. In addition to the effect of different pregnancy-related as sepsis, and preeclampsia which directly or indirectly predispose to pulmonary complications.
The presence of difficulty in the transfer of critically ill patients mandates point of care modality. Avoidance of fetal exposure to hazardous radiation demands safe technology. Ultrasound arises as a screening method that can be performed rapidly and enables healthcare providers to make timely decisions with no radiation exposure. Thus it facilitates the management of critically ill obstetric and gynecological patients.
When compared to other imaging techniques; X-ray imaging is preferably restricted in parturient because of the ionizing risk on the fetus, and CT is not feasible in critically ill if there is a risk of transfer. Thus ultrasound emerged as a bedside imaging technique.
Yet, the prevalence of the specific ultrasound signatures in that population is not clearly defined and its relation to poor outcome was not tested, This trial is the first trial to determine frequency, timing concerning admission, type of pulmonary abnormalities detectable by LUS, and their associations with poor outcome in patients whether obstetrics or gynecology admitted to the ICU specialized in women's intensive care
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obstetrics critically ill | – | Diagnostic Test: ultrasound detection of any abnormal ultrasonographical findings.critically ill obstetrics patients admitted yo ICU for any cause during pregnancy or postpartum. |
| gynecological critically ill patients | – | Diagnostic Test: ultrasound detection of any abnormal ultrasonographical findings.gynecological cases admitted to ICU for any cause of medical or postoperative care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- critically ill women admitted in the ICU for any medical, obstetric, or surgical causes.
Key inclusion criteria (1 listed)
- Any patient admitted to the obstetrics and gynecology intensive care unit
Key exclusion criteria (2 listed)
- Patient's refusal
- inability to do a lung ultrasound examination during the first 24 hours of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound detection of any abnormal ultrasonographical findings.ultrasound assessment within 24 hours. Then reassessment every 48 hours or when the patient develops respiratory distress. While the patient is in a supine or semi-recumbent position, and the probe is in a short axis. The 8-region technique will be used. The areas are four on each side of the chest. The examiner will assess 8 regions -Anterior chest wall ( ACW), Anterior axillary line (AAXL), costo-phrenic angle (COSTO), Postero-lateral alveolar \&/ or pleural syndrome (PLAPS) right and left . Each region will be scored using the LUS aeration score. as follows: "0," A-pattern with 0-2 B-lines; "1," more than 2 separated B-lines; "2," multiple coalescent B-lines; or "3," lung consolidation, . A global LUS score will be calculated at each time point and range from 0 to 24. posterior region will be assessed if needed and if feasible. The venous status will be assessed through a subcostal view for inferior vena cava diameter. | Diagnostic test | gynecological critically ill patients, obstetrics critically ill |
Primary outcome
the Prevalence of different ultrasonographical abnormal lung signatures
Time frame: From date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 days
presence or absence of us abnormalities as: abnormal sliding, interstitial syndrome, consolidation, cavitation, pleural effusion, or collapse
2 secondary outcomes
correlation of ultrasonographic finding with mortality or poor outcome
Time frame: from the appearance of abnormal ultrasonographic signature to death or disharge from ICU which comes first , assessed up to 20 days from the day of admission
timing of appearance of abnormal ultrasonography lung signatures
Time frame: on admission, after every 48 hours during ICU stay till death or dischrage from ICU which comes first, assessed up to 20 days from admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 37218800Rocca E, Zanza C, Longhitano Y, Piccolella F, Romenskaya T, Racca F, Savioli G, Saviano A, Piccioni A, Mongodi S. Lung Ultrasound in Critical Care and Emergency Medicine: Clinical Review. Adv Respir Med. 2023 May 17;91(3):203-223. doi: 10.3390/arm91030017.
- Background: PubMed 33319731Pisani L, De Nicolo A, Schiavone M, Adeniji AO, De Palma A, Di Gennaro F, Emuveyan EE, Grasso S, Henwood PC, Koroma AP, Leopold S, Marotta C, Marulli G, Putoto G, Pisani E, Russel J, Serpa Neto A, Dondorp AM, Hanciles E, Koroma MM, Schultz MJ. Lung Ultrasound for Detection of Pulmonary Complications in Critically Ill Obstetric Patients in a Resource-Limited Setting. Am J Trop Med Hyg. 2020 Dec 14;104(2):478-486. doi: 10.4269/ajtmh.20-0996.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
wessam selima, MD principal investigator
Ain Shams University
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 Obstetric Complication and Gynecologic Cancer, run by Ain Shams 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Prevalence of different ultrasonographical abnormal lung signatures (time frame: From date of admission untill Death from any cause or discharge from ICU, whichever comes first. assessed up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728709, which also lists 2 linked publications.
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 14 Jul 2026.