PARITY Program for Maternal Health

Overseen By Elizabeth K Mollard, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Nebraska

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 36-42 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called PARITY to improve health outcomes for pregnant Black women. The program provides support from community-based doulas, access to local resources, and a mobile app that sends positive health messages and encourages good habits like sleep, exercise, and nutrition. It aims to build on personal strengths, known as protective assets, to promote wellness during pregnancy. Black women who are pregnant between 20-28 weeks and live near Lincoln/Omaha, NE, might be a good fit if they have a smartphone with internet access. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pregnancy wellness for Black women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PARITY program is safe for pregnant Black women?

Research shows that the PARITY program helps pregnant Black women by offering support from community-based doulas, access to local resources, and a mobile app. Although specific safety data for the PARITY program is not available, this phase of the study focuses on assessing the program's practicality and acceptability. This focus usually indicates a low-risk program, as earlier study phases typically address safety issues.

The program builds on individual strengths and promotes wellness through supportive and non-invasive methods. Similar programs that emphasize community support and positive health messages have been well-received, with no major negative effects reported. Overall, the program aims to improve maternal health in a safe and supportive way. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PARITY program for maternal health because it uniquely combines community-based doula support, local resources, and mobile technology to support Black pregnant women. Unlike typical prenatal care, which often focuses on medical check-ups and guidance from healthcare providers, PARITY emphasizes enhancing individual strengths through positive messaging and promoting wellness activities like better sleep, nutrition, and physical activity. This holistic approach aims to create a supportive environment that could lead to healthier pregnancies and better maternal health outcomes.

What evidence suggests that the PARITY program is effective for maternal health?

Research shows that the PARITY program, available to participants in this trial, helps pregnant Black women by offering support through community doulas and a mobile app. This program aims to enhance personal strengths, known as protective assets, to encourage wellness. Early studies suggest this method may lead to better outcomes by promoting healthy habits like good nutrition, exercise, and prenatal care. The combination of technology and personal support addresses challenges in maternal health by building on existing strengths. Although specific data on its effectiveness is limited, the program’s design appears promising for improving health during pregnancy. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth K Mollard, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for pregnant Black women, between 20-28 weeks gestation, who can read and write in English. Participants must plan to give birth at a healthcare facility within the Lincoln/Omaha, NE metro area and own a smartphone with internet access.

Inclusion Criteria

I am pregnant and between 20 to 28 weeks along.

Ability to read and write in English language

Reside within 20 minutes of the Lincoln/Omaha, NE metro area

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PARITY program, which includes community-based doula support, community resources, and a mobile technology platform to promote wellness.

Approximately 36-42 weeks

Follow-up

Participants are monitored for self-efficacy, nutritional intake, healthcare adherence, and other outcomes postpartum.

6-12 weeks postpartum

Open-label extension (optional)

Participants may continue to receive support and monitoring through the PARITY program beyond the initial postpartum period.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• PARITY

Trial Overview The PARITY program is being tested against usual care. It includes community-based doula support, resources, and a mobile tech platform that sends positive messages and promotes wellness among pregnant Black women with high blood pressure.

How Is the Trial Designed?

Group I: PARITY Experimental Treatment 2 Interventions

Participants will take part in the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program which is community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.

Group II: Control Placebo Group 1 Intervention

Participants will obtain prenatal care from their usual care provider and a handout on healthy pregnancy.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

The GAIA project developed case definitions to assess adverse events in mothers and infants after immunization, and their applicability varied across 1248 case records from 7 high-resource sites, with neonatal outcomes being more assessable than maternal outcomes.

Certain outcomes like preterm birth and low birth weight had high positive predictive values (over 75%), while others like microcephaly were often nonassessable, indicating that the effectiveness of these definitions depends on the quality of clinical documentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries. Watson, G., Dodd, C., Munoz, FM., et al.[2022]

The implementation of a postpartum hemorrhage (PPH) safety program at a maternity hospital led to an increased use of effective treatments, such as more frequent administration of prostaglandin F2α and multiple types of uterotonics, indicating a quicker response to PPH cases.

Despite the improved treatment protocols, the overall rates of blood transfusions, hysterectomies, and ICU admissions remained unchanged, suggesting that while the program enhanced immediate care, it did not significantly alter severe outcome rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in care associated with the introduction of a postpartum hemorrhage patient safety program. Lappen, JR., Seidman, D., Burke, C., et al.[2019]

Only 58 maternal and perinatal serious adverse events (SAEs) were identified in the Health Quality and Safety Commission (HQSC) reports from 2009 to 2012, and only 50 of these matched the definitions used by the Perinatal and Maternal Mortality Review Committee (PMMRC), indicating a significant underreporting issue.

The PMMRC identified 536 potentially avoidable maternal and perinatal mortalities and morbidities during the same period, suggesting that fewer than 9% of these cases were captured by the HQSC, raising concerns about the reliability of HQSC reports for monitoring and improving maternity care quality in New Zealand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Under-reporting of maternal and perinatal adverse events in New Zealand. Farquhar, C., Armstrong, S., Kim, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11342005/

Protective Assets Reinforced With Integrated Care and ... PARITY is a strengths-focused intervention that uses mobile technology and doula support to empower individual women to bolster their existing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05802615

Protective Assets Reinforced With Integrated Care and ... This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39116423

Protocol for a Randomized Controlled Trial - PubMed - NIH The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program consists of a wellness technology platform, including ...

4. trialx.com trialx.com/clinical-trials/listings/270966/protective-assets-reinforced-with-integrated-care-and-technology-parity-feasibility-trial/

Protective Assets Reinforced With Integrated Care and ... This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) ...

5. app.dimensions.ai app.dimensions.ai/details/grant/grant.12966975

PARITY: An integrated community care and strengths ... This proposal addresses maternal morbidity and mortality and the impact of deficit-focused health care models on maternal health by leveraging the protective ...

6. withpower.com withpower.com/trial/phase-maternal-health-3-2023-84864

PARITY Program for Maternal Health · Info for Participants What safety data exists for the PARITY Program for Maternal Health treatment? ... The research highlights the importance of risk-appropriate care and ...

7. saferbirth.org saferbirth.org/

Alliance For Innovation On Maternal Health: AIM A quality improvement initiative to support best practices that make birth safer, improve maternal health outcomes and save lives.

8. psnet.ahrq.gov psnet.ahrq.gov/perspective/maternal-safety

Maternal Safety | PSNet Many more women experience serious pregnancy-related complications during and after childbirth that can have profound consequences.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0146000524000296

Alliance for Innovation on Maternal Health: Evolution of a ... This paper details key aspects of the Alliance for Innovation on Maternal Health including patient safety bundles, technical assistance, implementation resource ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24564721/

Linking high parity and maternal and child mortality Background: A number of data sets show that high parity births are associated with higher child mortality than low parity births.