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

NCT06053203 | Completed DMC

• 1 other identifier: NCT-ASPNSTD
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 4

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

Conditions

Hypertensive Disorders of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Aspirin Use Proportion

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

  12 weeks- 42 weeks gestation

Secondary Outcomes (1)

• Moderate or High-risk Preeclampsia Proportion.

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

Other Outcomes (1)

• Preeclampsia or Eclampsia proportion categorized as moderate or high risk

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

Study Arms (4)

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

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

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

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

Interventions

Exposure of interest - Moderate or High-risk Preeclampsia OTHER

No intervention

Amino Kano Teaching Hospital; Murtala Muhammad Specialist Hospital; National Hospital, Abuja; University of Abuja Teaching Hospital

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females who are pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide consent

Sponsors & Collaborators

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

Study Sites (4)

National Hospital, Abuja

Abuja, Nigeria

Location

University of Abuja Teaching Hospital

Gwagwalada, Nigeria

Location

Aminu Kano Teaching Hospital

Kano, Nigeria

Location

Murtala Muhammad Specialist Hospital

Kano, Nigeria

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine, Division of Cardiology

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 25, 2023
• Study Start: October 31, 2023
• Primary Completion: March 31, 2024
• Study Completion: November 30, 2024
• Last Updated: July 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 1 year of study conclusion
• 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

Locations

NG (4)