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

Active, not recruiting

• Conditions: Hypertensive Disorders of Pregnancy
• Interventions: Other: Exposure of interest - Moderate or High-risk Preeclampsia

• Registration Number: NCT06053203
• Lead Sponsor: Washington University School of Medicine

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.

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 Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-25
• Study Start: 2023-10-31
• Primary Completion: 2024-03-31
• Status Verified: 2024-11
• Study Completion: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
University of Abuja Teaching Hospital	Exposure of interest - Moderate or High-risk Preeclampsia	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.
National Hospital, Abuja	Exposure of interest - Moderate or High-risk Preeclampsia	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.
Murtala Muhammad Specialist Hospital	Exposure of interest - Moderate or High-risk Preeclampsia	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.
Amino Kano Teaching Hospital	Exposure of interest - Moderate or High-risk Preeclampsia	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (4)

National Hospital, Abuja; 🇳🇬 Abuja, Nigeria

University of Abuja Teaching Hospital; 🇳🇬 Gwagwalada, Nigeria

Aminu Kano Teaching Hospital; 🇳🇬 Kano, Nigeria

Murtala Muhammad Specialist Hospital; 🇳🇬 Kano, Nigeria