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Completed

NCT Number: NCT04421235

Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Childbirth support

Behavioral

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

Primary outcomes

  1. Program Utilization

    Time frame: Up to 12 months after delivery

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

  2. Program Acceptability

    Time frame: Up to 12 months after delivery

    Self-report ratings of the acceptability of each program component

Secondary outcomes

  1. Depressive Symptoms

    Time frame: Up to 12 months after delivery

    Self-report scores on Patient Health Questionnaire (PHQ-9)

  2. Depressive Symptoms

    Time frame: Up to 12 months after delivery

    Self-report scores on the Edinburgh Postnatal Depression Scale

  3. PTSD Symptoms

    Time frame: Up to 12 months after delivery

    Self-report scores on PTSD Checklist (PCL-5)

  4. Drug Use

    Time frame: Up to 12 months after delivery

    Binary self-report for common classes of drugs

  5. Health-Related Quality of Life

    Time frame: Up to 12 months after delivery

    Self-report scores on Quality of Life Scale (QOLS)

  6. Health-Related Quality of Life

    Time frame: Up to 12 months after delivery

    Self-report scores on the EQ-5D-5L

  7. Social Support

    Time frame: Up to 12 months after delivery

    Self-report scores on Multidimensional Scale of Perceived Social Support

  8. Parental Stress

    Time frame: Up to 12 months after delivery

    Self-report scores on the Parenting Stress Index

  9. Parental Sense of Competence

    Time frame: Up to 12 months after delivery

    Self-report scores on the Parenting Sense of Competence Scale

  10. Pregnancy Complications

    Time frame: 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

    Chart review to determine presence/absence of common pregnancy complications

  11. Childbirth Complications

    Time frame: Up to 12 months after delivery

    Chart review to determine presence/absence of common pregnancy complications

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2020
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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