The use of low-dose aspirin for the prevention of hypertensive disorders of pregnancy in a Sub-Saharan country
Phase 3
Completed
- Conditions
- Prevention of hypertensive disorders of pregnancy, in particular, pre-eclampsiaPregnancy and Childbirth
- Registration Number
- ISRCTN43031232
- Lead Sponsor
- niversity of KwaZulu-Natal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 423
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Gestational age measured at delivery <br>2. Baby weight measured in kg at birth<br>3. Infant outcome (dead or alive) during antenatal period