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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06053203
Collaborator
University of Abuja Teaching Hospital (Other), Aminu Kano Teaching Hospital (Other), Murtala Muhammad Specialist Hospital (Other), National Hospital, Abuja (Other)
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Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure of interest - Moderate or High-risk Preeclampsia

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:
  1. 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.

  2. 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

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Exposure of interest - Moderate or High-risk Preeclampsia
No intervention

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.

Other: Exposure of interest - Moderate or High-risk Preeclampsia
No intervention

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.

Other: Exposure of interest - Moderate or High-risk Preeclampsia
No intervention

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.

Other: Exposure of interest - Moderate or High-risk Preeclampsia
No intervention

Outcome Measures

Primary Outcome Measures

  1. Aspirin Use Proportion [12 weeks- 42 weeks gestation]

    Proportion of women (participants) at moderate- or high-risk of preeclampsia who report aspirin use.

Secondary Outcome Measures

  1. Moderate or High-risk Preeclampsia Proportion. [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Hospital, Abuja Abuja Nigeria
2 University of Abuja Teaching Hospital Gwagwalada Nigeria
3 Aminu Kano Teaching Hospital Kano Nigeria
4 Murtala Muhammad Specialist Hospital Kano Nigeria

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Mark Huffman, MD MPH, Washington University School of Medicine
  • Principal Investigator: Dike Ojji, MBBS PhD, University of Abuja Teaching Hospital
  • Principal Investigator: Kathryn Lindley, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zainab Mahmoud, Instructor in Medicine, Division of Cardiology, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT06053203
Other Study ID Numbers:
  • NCT-ASPNSTD
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023