NCT04421235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

May 27, 2020

Last Update Submit

July 17, 2025

Conditions

Keywords

Incarcerated WomenPrison

Outcome Measures

Primary Outcomes (2)

  • Program Utilization

    % of eligible women who choose to enroll in each program component

    Up to 12 months after delivery

  • Program Acceptability

    Self-report ratings of the acceptability of each program component

    Up to 12 months after delivery

Secondary Outcomes (11)

  • Depressive Symptoms

    Up to 12 months after delivery

  • Depressive Symptoms

    Up to 12 months after delivery

  • PTSD Symptoms

    Up to 12 months after delivery

  • Drug Use

    Up to 12 months after delivery

  • Health-Related Quality of Life

    Up to 12 months after delivery

  • +6 more secondary outcomes

Study Arms (1)

Childbirth Support

Women who enroll in the intervention portion of this study will receive the childbirth support elements for which they are eligible in and elect to participate. Possible program elements include prenatal education classes, support group, lactation program, doula support, and parenting classes.

Behavioral: Childbirth support

Interventions

There are 5 program components that women may receive as a part of childbirth support: Prenatal education - consists of up to 8 sessions of education on pregnancy, childbirth, and postpartum health and wellness. Support group - semi-structured group which provides time for women to process their pregnancy and postpartum-related experiences with other women facing similar challenges. Integrates mindfulness exercises, cognitive-behavioral skills, and special topics as requested by group members. Lactation program - program for women who wish to provide breastmilk for infants from which they are separated. Doula support program - 2 prenatal and 2 postnatal individual visits with a doula who will also provide continuous childbirth support and support during separation from infants. Parenting classes - group classes focused on helping women learn parenting skills and (if applicable) meet state requirements for reunification with children

Childbirth Support

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of administrative data on women who were: 1) incarcerated in the Hawkins Unit at Wrightsville Prison between June 1, 2014 to May 31, 2019 (a five-year cohort prior to initiation of Growing Together) and 2) who received pre- and/or post-natal health care services during that incarceration.

You may qualify if:

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

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalPatient Acceptance of Health CareHealth Risk Behaviors

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Melissa Zielinski, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 9, 2020

Study Start

November 19, 2021

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations