Low Birth WeightNCT06694233
Improving Aspirin Prescription Rates in Outpatient Clinic
An observational study of Low Birth Weight and Small for Gestational Age (SGA), run by Cairo University at 1 site in Kuwait.
Trial summary
Ρrееςlаmpѕia is a syndrome characterised by the new onset of hуреrtеnѕion plus proteinuria, end-organ dysfunction, or both after 20 weeks of gestation. It complicates 3-5% of pregnancies. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Low Birth Weight, Small for Gestational Age (SGA), Preeclampsia (PE)
- What is being tested?
- Aspirin prescription on outpatient basis
- How many people
- 300 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Nov 2024to 30 Apr 2025
- 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: Moderate- and high- risk obstetric population
Who may be able to join
- Women at high risk are those with any of the following:
- hypertensive disease during a previous pregnancy
- chronic kidney disease
- autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome
- type 1 or type 2 diabetes
- chronic hypertension.
Show all 13Show fewer
- Women with more than one moderate risk factor, such as are:
- nulliparity
- age 40 years or older
- pregnancy interval of more than 10 years
- body mass index (BMI) of 35 kg/m2 or more at first visit
- family history of pre-eclampsia
- multi-fetal pregnancy.
Who cannot join
- None. All eligible candidates will be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aspirin Prescription For Moderate- and High-Risk Obstetric Population in Outpatient Clnic; A Quality Improvement Project.
Ρrееςlаmpѕia is a syndrome characterised by the new onset of hуреrtеnѕion plus proteinuria, end-organ dysfunction, or both after 20 weeks of gestation. It complicates 3-5% of pregnancies.
Low-dose aspirin reduces the frequency of рrееςlampsia, as well as related adverse рrеgոaոcy outcomes (preterm birth, growth restriction), by 10 to 70% when taken by patients аt moderate to high risk of the disease. It has an excellent maternal/fetal safety profile. Thus, it is a reasonable preventive strategy for these patients.
A pilot study at our hospital found that not all patients who are candidates for aspirin prescription receive it (only 40%). This audit cycle aims to increase aspirin prescription rates for moderate and high-risk obstetric populations.
- Conditions
- Low Birth Weight, Small for Gestational Age (SGA), Preeclampsia (PE), Prevention &Amp; Control
- Being tested
- Aspirin prescription on outpatient basis
- Keywords
- Aspirin, Preeclampsia, obstetric, risk population
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin prescription on outpatient basisOther
Improving aspirin prescription rates for candidate patients (moderate- and high-risk obstetric population)
| Study group | Role | What they receive |
|---|---|---|
| Obstetric population candidate for aspirin prescription | Moderate- and high-risk obstetric population Receives: Other: Aspirin prescription on outpatient basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspirin prescription
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: Could not obtain ethical approval yet
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 Low Birth WeightStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Tarek Elkhateb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694233
- Sponsor's protocol ID
- QIP1
- Status last verified
- Jul 2025
- First submitted
- 14 Nov 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh N, Shuman S, Chiofalo J, Cabrera M, Smith A. Missed opportunities in aspirin prescribing for preeclampsia prevention. BMC Pregnancy Childbirth. 2023 Oct 7;23(1):717. doi: 10.1186/s12884-023-06039-w.
PubMed 37805449Kumar NR, Speedy SE, Song J, Welty LJ, Cavens AD. Quality Improvement Initiative for Aspirin Screening and Prescription Rates for Preeclampsia Prevention in an Outpatient Obstetric Clinic. Am J Perinatol. 2024 May;41(S 01):e917-e921. doi: 10.1055/s-0042-1759705. Epub 2022 Dec 30.
PubMed 36584691
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Prescription For Moderate- and High-Risk Obstetric Population in Outpatient Clnic; A Quality Improvement Project.
- ClinicalTrials.gov ID
- NCT06694233
- Acronym / sponsor ID
- QIP1
- Conditions
- Low Birth Weight, Small for Gestational Age (SGA), Preeclampsia (PE), Prevention &Amp; Control
- Keywords
- Aspirin, Preeclampsia, obstetric, risk population
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not obtain ethical approval yet
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Nov 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.
Ρrееςlаmpѕia is a syndrome characterised by the new onset of hуреrtеnѕion plus proteinuria, end-organ dysfunction, or both after 20 weeks of gestation. It complicates 3-5% of pregnancies.
Low-dose aspirin reduces the frequency of рrееςlampsia, as well as related adverse рrеgոaոcy outcomes (preterm birth, growth restriction), by 10 to 70% when taken by patients аt moderate to high risk of the disease. It has an excellent maternal/fetal safety profile. Thus, it is a reasonable preventive strategy for these patients.
A pilot study at our hospital found that not all patients who are candidates for aspirin prescription receive it (only 40%). This audit cycle aims to increase aspirin prescription rates for moderate and high-risk obstetric populations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstetric population candidate for aspirin prescription | – | Other: Aspirin prescription on outpatient basisModerate- and high-risk obstetric population |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Moderate- and high- risk obstetric population
Key inclusion criteria (13 listed)
- hypertensive disease during a previous pregnancy
- chronic kidney disease
- autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome
- type 1 or type 2 diabetes
- chronic hypertension.
Key exclusion criteria (1 listed)
- None. All eligible candidates will be included.
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 |
|---|---|---|
| Aspirin prescription on outpatient basisImproving aspirin prescription rates for candidate patients (moderate- and high-risk obstetric population) | Other | Obstetric population candidate for aspirin prescription |
Primary outcome
Aspirin prescription
Time frame: Six months
Results and safety
The study was stopped early (reason given: Could not obtain ethical approval yet). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 37805449Singh N, Shuman S, Chiofalo J, Cabrera M, Smith A. Missed opportunities in aspirin prescribing for preeclampsia prevention. BMC Pregnancy Childbirth. 2023 Oct 7;23(1):717. doi: 10.1186/s12884-023-06039-w.
- Background: PubMed 36584691Kumar NR, Speedy SE, Song J, Welty LJ, Cavens AD. Quality Improvement Initiative for Aspirin Screening and Prescription Rates for Preeclampsia Prevention in an Outpatient Obstetric Clinic. Am J Perinatol. 2024 May;41(S 01):e917-e921. doi: 10.1055/s-0042-1759705. Epub 2022 Dec 30.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low Birth Weight and Small for Gestational Age (SGA), run by Cairo University at 1 site in Kuwait.
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 13 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Jul 2025. 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 Kuwait. 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 was stopped early (reason given: Could not obtain ethical approval yet). Results are not available in the source record.
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?
Aspirin prescription (time frame: Six months). 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 NCT06694233, 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 10 Jul 2025.