The use of low-dose aspirin for the prevention of hypertensive disorders of pregnancy in a Sub-Saharan country
| ISRCTN | ISRCTN43031232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43031232 |
| Secondary identifying numbers | BREC BFC163/19 |
- Submission date
- 19/08/2024
- Registration date
- 23/08/2024
- Last edited
- 22/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In South Africa, the level of hypertensive (high blood pressure) disorders of pregnancy remains high. The Saving Mothers executive summary report (2020-2022) states that hypertensive disorders of pregnancy are the third leading cause of deaths occurring to mothers during and after pregnancy, accounting for 14.7% of all deaths in SA and the impact of COVID-19 pandemic led to current status.
Therefore, this study aims to determine the effect of low-dose aspirin in pregnant women of African ancestry and its association with hypertensive disorders of pregnancy. The study evaluates aspirin as a treatment for primary prevention of hypertensive disorders, including preeclampsia in all pregnant women considered to be at high risk following first -three months of pregnancy. Also , to evaluate the effects of aspirin on the occurrence in early (delivery before 34 weeks of pregnancy) preeclampsia, the rate of unexpected growth of small size baby in the womb, loss in the womb during delivery and after delivery, placental separation before delivery and admission to neonatal intensive care as secondary prevention.
Who can participate?
Pregnant women, between 12 to 20 weeks of pregnancy aged 18 years and above and that are considered to be at risk of hypertensive disorders of pregnancy.
What does the study involve?
The study involves low-dose aspirin intake (162mg) daily at night from the day of recruitment until 36 of pregnancy, or treatment as usual, thereafter followed up until delivery.
What are the possible benefits and risks of participating?
The benefits of participating in the study was the reduced occurrence of hypertensive disorders of pregnancy involving preeclampsia and gestational hypertension.
Where is the study run from?
University of Kwa-Zulu Natal college of health sciences (South Africa). The study was conducted in a regional hospital in KwaZulu-Natal province of South Africa.
When is the study starting and how long is it expected to run for?
The study commenced in March 2019 and ended in April 2024 It could not continue due to COVID-19 pandemic and KwaZulu-Natal floods that affected the entire recruitment.
Who is funding the study?
University of Kwa-Zulu Natal college of health sciences and the Women’s health and HIV research unit (South Africa)
Who is the main contact?
Princess Zinhle Mkhize, zihlandla@yahoo.com
Contact information
Public, Scientific, Principal Investigator
60 Marian Dale complex
Marianhill park
Pinetown
Durban
3610
South Africa
 ORCID ID |
0000-0002-9823-9460 |
|---|---|
| Phone | +27 833924358 |
| 971136680@stu.ukzn.ac.za |
Scientific
Room 196 Main building
Nelson R. Mandela School of Medicine
University of KwaZulu-Natal
719 Umbilo Road
Berea
Durban
4001
South Africa
| ORCID ID |
0000-0003-1130-9364 |
|---|---|
| Phone | +27 312604675 |
| jmog@ukzn.ac.za |
Public, Scientific
Room 220 Main building
Nelson Mandela School of Medicine
University of KwaZulu-Natal
719 Umbilo Road
Berea
Durban
4001
South Africa
| ORCID ID |
0000-0002-0655-697X |
|---|---|
| Phone | +27 847447611 |
| dorsamyv1@ukzn.ac.za |
Study information
| Study design | Single centre interventional open labelled parallel randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Prevention, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | The effect of low dose aspirin in the prevention of hypertensive disorders of pregnancy: A parallel open labelled randomized controlled trial |
| Study acronym | ELDAPPE study |
| Study objectives | Does administration of low dose aspirin result in a decrease in frequency of hypertensive disorders when prescribed in early pregnancy |
| Ethics approval(s) |
Approved 10/09/2020, Biomedical Research Ethics Committee, University of KwaZulu-Natal (Biomedical Research Ethics Committee Research Office, UKZN Private Bag X 54001 Durban 4000, Durban, 4001, South Africa; +27 2604709; BREC@ukzn.ac.za), ref: BFC136/19 |
| Health condition(s) or problem(s) studied | Prevention of hypertensive disorders of pregnancy, in particular, pre-eclampsia |
| Intervention | 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 (LDA) in preventing HDP in women of African ancestry. Normotensive pregnant women aged ≥18 years, with singleton pregnancies between 12 and 20 weeks of gestation, were recruited from the study site’s antenatal clinic. The intention was to recruit between 12-16 weeks gestation. The initial intention was to recruit 970 participants, with equal numbers assigned to the intervention and control groups. Due to recruitment challenges, 423 participants were eventually enrolled. The initial sample (970), size was statistically obtained based on hypertensive disorder incidence (12%) in South African context. A simple random sampling was conducted to select women based on the inclusion and exclusion criteria. Randomization and Grouping: Participants were randomly assigned to either the intervention group (n=209) or the control group (n=214) using a simple 1:1 allocation ratio. As such randomisation occurred based on a coin toss with one participant allocated to the representation of the coin face and the following participant that was recruited was allocated to the alternate group. The intervention group received low-dose aspirin (Ecotrin, 162 mg daily) monthly supply, while the control group received standard antenatal care without aspirin. Intervention: LDA was initiated between 12 and 20 weeks of gestation and continued until 36 weeks. Participants in the intervention group were instructed to take 162 mg of LDA nightly. Compliance was monitored through “pill counts” and bi-weekly telephonic interviews |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Aspirin [Ecotrin] |
| Primary outcome measure | 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 | 1. Gestational age measured at delivery 2. Baby weight measured in kg at birth 3. Infant outcome (dead or alive) during antenatal period |
| Overall study start date | 01/03/2019 |
| Completion date | 01/04/2024 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Female |
| Target number of participants | 970 |
| Total final enrolment | 423 |
| Key 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, |
| Key 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 |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 31/01/2024 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Mangosuthu Highway
Durban
4001
South Africa
Sponsor information
University/education
238 Mazisi Kunene Road
Glenwood
Durban
4041
South Africa
| Phone | +27 312608596 / 312601111 |
|---|---|
| enquiries@ukzn.ac.za | |
| Website | http://www.ukzn.ac.za/ |
"ROR" |
https://ror.org/04qzfn040 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of KwaZulu-Natal, College of Health Sciences, UKZN’s College of Health Sciences, College of Health Sciences, College of Health Sciences - UKZN, University of KwaZulu-Natal College of Health Sciences, UKZN's CHS, CHS, UKZN CHS
- Location
- South Africa
Results and Publications
| Intention to publish date | 10/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Research articles emanating from this study has and will be submitted for publication in peer-reviewed journals. The results for the research will also be presented at both local and international conferences. The study is in fulfillment of a PhD thesis |
| IPD sharing plan | The dataset generated and analysed during the current study are not expected to be made available as there is ongoing study related to the work, however where data needs to be made available as it pertains to a particular outcome that is being published, that data will be made available for transparency |
Editorial Notes
19/08/2024: Trial's existence confirmed by University of KwaZulu-Natal
