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The use of low-dose aspirin for the prevention of hypertensive disorders of pregnancy in a Sub-Saharan country

The effect of low dose aspirin in the prevention of hypertensive disorders of pregnancy: A parallel open labelled randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43031232
Enrollment
970
Registered
2024-08-23
Start date
2021-05-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of hypertensive disorders of pregnancy, in particular, pre-eclampsia Pregnancy and Childbirth

Interventions

This was a single center interventional, open labelled randomized controlled trial. The study was conducted at a regional hospital in South Africa to evaluate the effectiveness of low-dose aspirin (LD

Sponsors

University of KwaZulu-Natal
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women that is 18 years and older 2. Pregnant women and women with one or more risk factors for hypertensive disorders of pregnancy, such as a previous history of unexplained pregnancy loss, 3. Previous history or family history of hypertensive disorders,

Exclusion criteria

Exclusion criteria: 1. Women on aspirin or other antiplatelet agents 2. Women with multiple pregnancies 3. Women with fetal abnormalities, diabetes, hypertension, anemia, or other chronic diseases. 4. women with contraindications to aspirin use 5. Women who decline entry to the study

Design outcomes

Primary

MeasureTime frame
Incidence of hypertensive disorders of pregnancy including pre-eclampsia (both early and late) and gestational hypertension (defined as a systolic blood pressure (SBP) =140 mm Hg and/or diastolic blood pressure (DBP) =90 mm Hg after 20 weeks of gestation in a woman who was at baseline normotensive) measured using a sphygmomanometer

Secondary

MeasureTime frame
1. Gestational age measured at delivery 2. Baby weight measured in kg at birth 3. Infant outcome (dead or alive) during antenatal period

Countries

South Africa

Contacts

Public ContactPrincess Zinhle;Vinogrin Mkhize;Dorsamy

;

971136680@stu.ukzn.ac.za;dorsamyv1@ukzn.ac.za+27 833924358;+27 847447611

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026