NCT06694233

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

November 14, 2024

Last Update Submit

July 6, 2025

Conditions

Keywords

AspirinPreeclampsiaobstetricrisk population

Outcome Measures

Primary Outcomes (1)

  • Aspirin prescription

    Six months

Study Arms (1)

Obstetric population candidate for aspirin prescription

Moderate- and high-risk obstetric population

Other: Aspirin prescription on outpatient basis

Interventions

Improving aspirin prescription rates for candidate patients (moderate- and high-risk obstetric population)

Obstetric population candidate for aspirin prescription

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsObstetric population
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Moderate- and high- risk obstetric population

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • None. All eligible candidates will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adan hospital

Al Ahmadi, Al Ahmadi, 47000, Kuwait

Location

Related Publications (2)

  • 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.

    PMID: 37805449BACKGROUND
  • Kumar 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.

    PMID: 36584691BACKGROUND

Related Links

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 19, 2024

Study Start

November 1, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations