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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Disorders of Pregnancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Zainab Mahmoud, MD MSc; Phone Number: 08090299333; Email: zmahmoud@wustl.edu
• Study Contact Backup: Name: Dike Ojji, MBBS PhD; Phone Number: 08060094456; Email: dike.ojji@uniabuja.edu.ng

Study Locations

• Nigeria
  • Abuja, Nigeria
    • National Hospital, Abuja
    • Contact: Dike Ojji
    • Principal Investigator: Zainab Mahmoud, MD MSc
  • Gwagwalada, Nigeria
    • University of Abuja Teaching Hospital
    • Contact: Dike Ojji, MBBS PhD; Phone Number: 08060094456; Email: dike.ojji@uniabuja.edu.ng
    • Principal Investigator: Zainab Mahmoud, MD MSc
  • Kano, Nigeria
    • Aminu Kano Teaching Hospital
    • Contact: Dike Ojji
    • Principal Investigator: Zainab Mahmoud, MD MSc
  • Kano, Nigeria
    • Murtala Muhammad Specialist Hospital
    • Contact: Dike Ojji
    • Principal Investigator: Zainab Mahmoud, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspirin Use Proportion	Proportion of women (participants) at moderate- or high-risk of preeclampsia who report aspirin use.	12 weeks- 42 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or High-risk Preeclampsia Proportion.	Proportion of women at moderate- to high-risk of preeclampsia among those attending antenatal care who are participants.	Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preeclampsia or Eclampsia proportion categorized as moderate or high risk	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.	Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Aminu Kano Teaching Hospital; University of Abuja Teaching Hospital; National Hospital, Abuja; Murtala Muhammad Specialist Hospital
• Investigators: Principal Investigator: Dike Ojji, MBBS PhD, University of Abuja Teaching Hospital; Principal Investigator: Mark Huffman, MD MPH, Washington University School of Medicine; Principal Investigator: Kathryn Lindley, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Toxemia; Hypertension; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: NCT-ASPNSTD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available within 1 year of study completion.
• IPD Sharing Time Frame: Data will be available within 1 year of study conclusion

IPD Sharing Access Criteria

After completion of this study, to ensure that our results are used by researchers, policymakers, and community-based organizations, we will disseminate our results through the following:

• Organize community fora to share results with patients that participated in the study
• Peer-review all published products with the research team and study partners
• Report the results at conferences that target researchers, community health providers, and policymakers

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No