Health Problems in PregnancyNCT04421235
Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
An observational study of Health Problems in Pregnancy and Childbirth Problems, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Health Problems in Pregnancy, Childbirth Problems, Maternal Care Patterns
- What is being tested?
- Childbirth support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2021to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Women incarcerated in Arkansas state prison system
- 18 years or older
- Able to give informed consent
- Pregnant or has given birth in past year
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 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.
- Conditions
- Health Problems in Pregnancy, Childbirth Problems, Maternal Care Patterns, Quality of Life, Emotional Stress, Health Care Acceptability
- Being tested
- Childbirth support
- Keywords
- Incarcerated Women, Prison
- Medical subject headings
- Stress, Psychological, Patient Acceptance of Health Care, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childbirth supportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Childbirth support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Utilization
% of eligible women who choose to enroll in each program component
Measured: Up to 12 months after delivery
Program Acceptability
Self-report ratings of the acceptability of each program component
Measured: Up to 12 months after delivery
Secondary outcomes (11)
Depressive Symptoms
Self-report scores on Patient Health Questionnaire (PHQ-9)
Measured: Up to 12 months after delivery
Depressive Symptoms
Self-report scores on the Edinburgh Postnatal Depression Scale
Measured: Up to 12 months after delivery
PTSD Symptoms
Self-report scores on PTSD Checklist (PCL-5)
Measured: Up to 12 months after delivery
Drug Use
Binary self-report for common classes of drugs
Measured: Up to 12 months after delivery
Health-Related Quality of Life
Self-report scores on Quality of Life Scale (QOLS)
Measured: Up to 12 months after delivery
Health-Related Quality of Life
Self-report scores on the EQ-5D-5L
Measured: Up to 12 months after delivery
Social Support
Self-report scores on Multidimensional Scale of Perceived Social Support
Measured: Up to 12 months after delivery
Parental Stress
Self-report scores on the Parenting Stress Index
Measured: Up to 12 months after delivery
Parental Sense of Competence
Self-report scores on the Parenting Sense of Competence Scale
Measured: Up to 12 months after delivery
Pregnancy Complications
Chart review to determine presence/absence of common pregnancy complications
Measured: 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
Chart review to determine presence/absence of common pregnancy complications
Measured: Up to 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start19 Nov 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Problems in PregnancyStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Melissa Zielinski, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421235
- Sponsor's protocol ID
- 260265
- Other IDs
- UL1TR003107
- Status last verified
- Jul 2025
- First submitted
- 27 May 2020
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Together: Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas
- ClinicalTrials.gov ID
- NCT04421235
- Acronym / sponsor ID
- 260265
- Conditions
- Health Problems in Pregnancy, Childbirth Problems, Maternal Care Patterns, Quality of Life, Emotional Stress, Health Care Acceptability
- Keywords
- Incarcerated Women, Prison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childbirth Support | – | Behavioral: Childbirth supportWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Women incarcerated in Arkansas state prison system
- 18 years or older
- Able to give informed consent
- Pregnant or has given birth in past year
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Childbirth supportThere 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 | Behavioural | Childbirth Support |
Primary outcome
Program Utilization
Time frame: Up to 12 months after delivery
% of eligible women who choose to enroll in each program component
Program Acceptability
Time frame: Up to 12 months after delivery
Self-report ratings of the acceptability of each program component
11 secondary outcomes
Depressive Symptoms
Time frame: Up to 12 months after delivery
Depressive Symptoms
Time frame: Up to 12 months after delivery
PTSD Symptoms
Time frame: Up to 12 months after delivery
Drug Use
Time frame: Up to 12 months after delivery
Health-Related Quality of Life
Time frame: Up to 12 months after delivery
Health-Related Quality of Life
Time frame: Up to 12 months after delivery
Social Support
Time frame: Up to 12 months after delivery
Parental Stress
Time frame: Up to 12 months after delivery
Parental Sense of Competence
Time frame: 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
Childbirth Complications
Time frame: Up to 12 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Zielinski, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Problems in Pregnancy and Childbirth Problems, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Utilization (time frame: Up to 12 months after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.