Hypertensive Disorders of PregnancyNCT06053203
Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods Study
An observational study of Hypertensive Disorders of Pregnancy, run by Washington University School of Medicine at 4 sites in Nigeria.
Trial summary
The goal of this study is to evaluate the use of aspirin for the prevention of preeclampsia among moderate -to- high-risk pregnant women in tertiary care hospitals in Nigeria followed by a qualitative study to evaluate the barriers and facilitators of aspirin use in prenatal care for the prevention of preeclampsia in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disorders of Pregnancy
- What is being tested?
- Exposure of interest - Moderate or High-risk Preeclampsia
- How many people
- 1,200 participants
- Where
- 4 sitesNigeria
- Study dates
- 31 Oct 2023to 30 Nov 2024
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women attending antenatal clinic or presenting to the labor ward at 2 tertiary and 2 secondary health facilities in the Federal capital territory and Kano state of Nigeria.
Who may be able to join
- Adult pregnant woman > 18 years old / emancipated pregnant minors (<18years), according to the stipulations of the Nigerian National Health Research Ethics Committee (NRHEC)
- >12 weeks' gestation attending antenatal care clinics on 2nd or subsequent visit
- Those presenting to the labor and delivery room.
Who cannot join
- Unable to provide consent
Trial locations and contacts
4 sites in 1 country.
Nigeria4 sites
National Hospital, Abuja
Abuja
University of Abuja Teaching Hospital
Gwagwalada
Aminu Kano Teaching Hospital
Kano
Murtala Muhammad Specialist Hospital
Kano
About this study
The goal of this study is to evaluate the use of aspirin for the prevention of preeclampsia among moderate -to- high-risk pregnant women in tertiary care hospitals in Nigeria followed by a qualitative study to evaluate the barriers and facilitators of aspirin use in prenatal care for the prevention of preeclampsia in Nigeria. The main question[s] it aims to answer are:
- Is Aspirin used for the prevention of preeclampsia among pregnant women in Nigeria?
- What factors promote or prevent the utilization of Aspirin for preeclampsia prevention among pregnant women in Nigeria.
Read the detailed description
Nigeria has the highest burden of maternal mortality worldwide accounting for over 1 in 4 of global maternal deaths. In a 2022 nationwide analysis of maternal outcomes in 76,563 deliveries across referral-level hospitals in Nigeria, hypertensive disorders of pregnancy (HDP) including preeclampsia accounted for 32% of maternal deaths. Studies have linked the pathophysiology of preeclampsia to peripartum cardiomyopathy (PPCM) which is prevalent in Nigeria.5,6 Patients with PPCM were 4 times as likely to have preeclampsia that patients without PPCM. Among known evidence-based interventions for HDP, aspirin prophylaxis stands out as among the most highly effective in preeclampsia prevention. A comprehensive understanding of utilization patterns, or lack thereof, as well as the identification of barriers and facilitators, can inform implementation studies aimed at increasing adoption of this highly effective and cost-effective intervention.
Aims:
- To conduct a multisite cross-sectional study to evaluate the utilization of aspirin use for the prevention of preeclampsia amongst moderate- to high-risk pregnant women in tertiary care hospitals in Nigeria. We hypothesize that there is underutilization of aspirin for the prevention of preeclampsia amongst pregnant women at moderate- to high-risk of preeclampsia in Nigeria.
- To conduct a qualitative research study to evaluate facilitators and barriers to aspirin use in prenatal care for prevention of preeclampsia in Nigeria. We hypothesize that there is underutilization of aspirin for the prevention of preeclampsia amongst pregnant women at moderate- to high- risk of preeclampsia in Nigeria.
- Conditions
- Hypertensive Disorders of Pregnancy
- Being tested
- Exposure of interest - Moderate or High-risk Preeclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of interest - Moderate or High-risk PreeclampsiaOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| University of Abuja Teaching Hospital | Pregnant women with Hypertensive Disorder of Pregnancy who seek care in the Federal Capital Territory, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. Receives: Other: Exposure of interest - Moderate or High-risk Preeclampsia | |
| Amino Kano Teaching Hospital | Pregnant women with Hypertensive Disorder of Pregnancy who seek care in Kano State in Nigeria, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. Receives: Other: Exposure of interest - Moderate or High-risk Preeclampsia | |
| National Hospital, Abuja | Pregnant women with Hypertensive Disorder of Pregnancy who seek care in the Federal Capital Territory, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. Receives: Other: Exposure of interest - Moderate or High-risk Preeclampsia | |
| Murtala Muhammad Specialist Hospital | Pregnant women with Hypertensive Disorder of Pregnancy who seek care in Kano State in Nigeria, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. Receives: Other: Exposure of interest - Moderate or High-risk Preeclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspirin Use Proportion
Proportion of women (participants) at moderate- or high-risk of preeclampsia who report aspirin use.
Measured: 12 weeks- 42 weeks gestation
Secondary outcomes (1)
Moderate or High-risk Preeclampsia Proportion.
Proportion of women at moderate- to high-risk of preeclampsia among those attending antenatal care who are participants.
Measured: Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start31 Oct 2023
- Primary completion31 Mar 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Abuja Teaching Hospital, Aminu Kano Teaching Hospital, Murtala Muhammad Specialist Hospital, National Hospital, Abuja
- Responsible party
- Principal investigator, Zainab Mahmoud, Washington University School of Medicine
- Investigators
- Mark Huffman, MD MPH, Principal investigator, Washington University School of MedicineDike Ojji, MBBS PhD, Principal investigator, University of Abuja Teaching HospitalKathryn Lindley, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053203
- Sponsor's protocol ID
- NCT-ASPNSTD
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available within 1 year of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06053203
- Acronym / sponsor ID
- NCT-ASPNSTD
- Conditions
- Hypertensive Disorders of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Abuja Teaching Hospital, Aminu Kano Teaching Hospital, Murtala Muhammad Specialist Hospital, National Hospital, Abuja
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 25 Sep 2023 (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.
The goal of this study is to evaluate the use of aspirin for the prevention of preeclampsia among moderate -to- high-risk pregnant women in tertiary care hospitals in Nigeria followed by a qualitative study to evaluate the barriers and facilitators of aspirin use in prenatal care for the prevention of preeclampsia in Nigeria. The main question[s] it aims to answer are:
- Is Aspirin used for the prevention of preeclampsia among pregnant women in Nigeria?
- What factors promote or prevent the utilization of Aspirin for preeclampsia prevention among pregnant women in Nigeria.
Detailed description
Nigeria has the highest burden of maternal mortality worldwide accounting for over 1 in 4 of global maternal deaths. In a 2022 nationwide analysis of maternal outcomes in 76,563 deliveries across referral-level hospitals in Nigeria, hypertensive disorders of pregnancy (HDP) including preeclampsia accounted for 32% of maternal deaths. Studies have linked the pathophysiology of preeclampsia to peripartum cardiomyopathy (PPCM) which is prevalent in Nigeria.5,6 Patients with PPCM were 4 times as likely to have preeclampsia that patients without PPCM. Among known evidence-based interventions for HDP, aspirin prophylaxis stands out as among the most highly effective in preeclampsia prevention. A comprehensive understanding of utilization patterns, or lack thereof, as well as the identification of barriers and facilitators, can inform implementation studies aimed at increasing adoption of this highly effective and cost-effective intervention.
Aims:
- To conduct a multisite cross-sectional study to evaluate the utilization of aspirin use for the prevention of preeclampsia amongst moderate- to high-risk pregnant women in tertiary care hospitals in Nigeria. We hypothesize that there is underutilization of aspirin for the prevention of preeclampsia amongst pregnant women at moderate- to high-risk of preeclampsia in Nigeria.
- To conduct a qualitative research study to evaluate facilitators and barriers to aspirin use in prenatal care for prevention of preeclampsia in Nigeria. We hypothesize that there is underutilization of aspirin for the prevention of preeclampsia amongst pregnant women at moderate- to high- risk of preeclampsia in Nigeria.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| University of Abuja Teaching Hospital | – | Other: Exposure of interest - Moderate or High-risk PreeclampsiaPregnant women with Hypertensive Disorder of Pregnancy who seek care in the Federal Capital Territory, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. |
| Amino Kano Teaching Hospital | – | Other: Exposure of interest - Moderate or High-risk PreeclampsiaPregnant women with Hypertensive Disorder of Pregnancy who seek care in Kano State in Nigeria, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. |
| National Hospital, Abuja | – | Other: Exposure of interest - Moderate or High-risk PreeclampsiaPregnant women with Hypertensive Disorder of Pregnancy who seek care in the Federal Capital Territory, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. |
| Murtala Muhammad Specialist Hospital | – | Other: Exposure of interest - Moderate or High-risk PreeclampsiaPregnant women with Hypertensive Disorder of Pregnancy who seek care in Kano State in Nigeria, attending antenatal clinics on the 2nd or subsequent visit and pregnant women presenting to the labor and delivery room. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women attending antenatal clinic or presenting to the labor ward at 2 tertiary and 2 secondary health facilities in the Federal capital territory and Kano state of Nigeria.
Key inclusion criteria (3 listed)
- Adult pregnant woman > 18 years old / emancipated pregnant minors (<18years), according to the stipulations of the Nigerian National Health Research Ethics Committee (NRHEC)
- >12 weeks' gestation attending antenatal care clinics on 2nd or subsequent visit
- Those presenting to the labor and delivery room.
Key exclusion criteria (1 listed)
- Unable to provide consent
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 |
|---|---|---|
| Exposure of interest - Moderate or High-risk PreeclampsiaNo intervention | Other | Amino Kano Teaching Hospital, Murtala Muhammad Specialist Hospital, National Hospital, Abuja, University of Abuja Teaching Hospital |
Primary outcome
Aspirin Use Proportion
Time frame: 12 weeks- 42 weeks gestation
Proportion of women (participants) at moderate- or high-risk of preeclampsia who report aspirin use.
1 secondary outcome
Moderate or High-risk Preeclampsia Proportion.
Time frame: Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD will be available within 1 year of study completion.
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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.
Mark Huffman, MD MPH principal investigator
Washington University School of Medicine
Dike Ojji, MBBS PhD principal investigator
University of Abuja Teaching Hospital
Kathryn Lindley principal investigator
Vanderbilt University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorders of Pregnancy, run by Washington University School of Medicine at 4 sites in Nigeria.
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 3 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: finished, as of the sponsor's last update on 2 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 4 sites in Nigeria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Use Proportion (time frame: 12 weeks- 42 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025.