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

October 11, 2023 updated by: University of Arkansas

Growing Together: 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Utilization
Time Frame: Up to 12 months after delivery
% of eligible women who choose to enroll in each program component
Up to 12 months after delivery
Program Acceptability
Time Frame: Up to 12 months after delivery
Self-report ratings of the acceptability of each program component
Up to 12 months after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: Up to 12 months after delivery
Self-report scores on Patient Health Questionnaire (PHQ-9)
Up to 12 months after delivery
Depressive Symptoms
Time Frame: Up to 12 months after delivery
Self-report scores on the Edinburgh Postnatal Depression Scale
Up to 12 months after delivery
PTSD Symptoms
Time Frame: Up to 12 months after delivery
Self-report scores on PTSD Checklist (PCL-5)
Up to 12 months after delivery
Drug Use
Time Frame: Up to 12 months after delivery
Binary self-report for common classes of drugs
Up to 12 months after delivery
Health-Related Quality of Life
Time Frame: Up to 12 months after delivery
Self-report scores on Quality of Life Scale (QOLS)
Up to 12 months after delivery
Health-Related Quality of Life
Time Frame: Up to 12 months after delivery
Self-report scores on the EQ-5D-5L
Up to 12 months after delivery
Social Support
Time Frame: Up to 12 months after delivery
Self-report scores on Multidimensional Scale of Perceived Social Support
Up to 12 months after delivery
Parental Stress
Time Frame: Up to 12 months after delivery
Self-report scores on the Parenting Stress Index
Up to 12 months after delivery
Parental Sense of Competence
Time Frame: Up to 12 months after delivery
Self-report scores on the Parenting Sense of Competence Scale
Up to 12 months after delivery
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
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
Childbirth Complications
Time Frame: Up to 12 months after delivery
Chart review to determine presence/absence of common pregnancy complications
Up to 12 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Melissa Zielinski, Phd, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 260265
  • PTC2020-02 (Other Grant/Funding Number: UAMS Translational Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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