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NCT Number: NCT06053203

Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods 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:

1. Is Aspirin used for the prevention of preeclampsia among pregnant women in Nigeria? 2. What factors promote or prevent the utilization of Aspirin for preeclampsia prevention among pregnant women in Nigeria.

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Key information

Conditions

Hypertensive Disorders of Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

National Hospital, Abuja, Abuja, Nigeria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unable to provide consent

Treatment and study plan

Exposure of interest - Moderate or High-risk Preeclampsia

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Moderate or High-risk Preeclampsia Proportion.

    Time frame: Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation

    Proportion of women at moderate- to high-risk of preeclampsia among those attending antenatal care who are participants.

Other outcomes

  1. Preeclampsia or Eclampsia proportion categorized as moderate or high risk

    Time frame: Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation

    Proportion of women presenting with preeclampsia or eclampsia at delivery who would have been categorized as moderate or high- risk at antenatal care visits out of the entire cohort of pregnant participants.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Aminu Kano Teaching Hospital
  • Murtala Muhammad Specialist Hospital
  • National Hospital, Abuja
  • University of Abuja Teaching Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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