Clinical trial NCT06053203: Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods Study
Official title: Utilization of Aspirin for Prevention of Pre-Eclampsia in Nigeria: A Explanatory Sequential Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertensive Disorders of Pregnancy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Abuja Teaching Hospital
name: Aminu Kano Teaching Hospital
name: Murtala Muhammad Specialist Hospital
name: National Hospital, Abuja
First posted: 2023-09-25
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aspirin Use Proportion
timeFrame: 12 weeks- 42 weeks gestation
Secondary outcomes:
measure: Moderate or High-risk Preeclampsia Proportion.
timeFrame: Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation
Other outcomes:
measure: Preeclampsia or Eclampsia proportion categorized as moderate or high risk
timeFrame: Throughout study duration, from 2nd antenatal visit or after 12 weeks' gestation
Locations:
city: Abuja
country: Nigeria
facility: National Hospital, Abuja
city: Gwagwalada
country: Nigeria
facility: University of Abuja Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Kano
country: Nigeria
facility: Murtala Muhammad Specialist Hospital
Study officials:
affiliation: Washington University School of Medicine
name: Mark Huffman, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja Teaching Hospital
name: Dike Ojji, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Kathryn Lindley
role: PRINCIPAL_INVESTIGATOR
References: