Clinical trial NCT04421235: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Official title: Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Problems in Pregnancy
Childbirth Problems
Maternal Care Patterns
Quality of Life
Emotional Stress
Health Care Acceptability
Health Risk Behaviors
Parent-Child Relations
Keywords: Incarcerated Women
Prison
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.


Eligibility criteria: Inclusion Criteria:

* Women incarcerated in Arkansas state prison system
* 18 years or older
* Able to give informed consent
* Pregnant or has given birth in past year

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Program Utilization
timeFrame: Up to 12 months after delivery
measure: Program Acceptability
timeFrame: Up to 12 months after delivery
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Up to 12 months after delivery
measure: Depressive Symptoms
timeFrame: Up to 12 months after delivery
measure: PTSD Symptoms
timeFrame: Up to 12 months after delivery
measure: Drug Use
timeFrame: Up to 12 months after delivery
measure: Health-Related Quality of Life
timeFrame: Up to 12 months after delivery
measure: Health-Related Quality of Life
timeFrame: Up to 12 months after delivery
measure: Social Support
timeFrame: Up to 12 months after delivery
measure: Parental Stress
timeFrame: Up to 12 months after delivery
measure: Parental Sense of Competence
timeFrame: Up to 12 months after delivery
measure: Pregnancy Complications
timeFrame: From the date of enrollment until the date of childbirth or the date of pregnancy loss or termination, whichever came first, assessed up to 50 weeks
measure: Childbirth Complications
timeFrame: Up to 12 months after delivery
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Melissa Zielinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: