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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness.

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 data supports the effectiveness of the PARITY treatment for maternal health?

The research highlights the importance of risk-appropriate care and standardized protocols in improving maternal health outcomes, which suggests that treatments like PARITY that focus on these aspects could be effective in reducing maternal morbidity and mortality. ^{1 2 3 4 5}

What safety data exists for the PARITY Program for Maternal Health treatment?

The GAIA project has developed standardized definitions to assess adverse events in mothers and infants following maternal immunization, which can help evaluate safety in clinical trials. These definitions have been applied in high-resource settings to monitor vaccine safety during pregnancy. ^{6 7 8 9 10}

Research Team

Elizabeth K Mollard, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

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

Black race

I plan to give birth in a hospital and have a medical record there.

I am pregnant and between 20 to 28 weeks along.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Risk-Appropriate Care to Improve Practice and Birth Outcomes. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A review of maternal mortality and quality of care in the USA. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of maternal health programs: approaches, methods and indicators. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Where is the "M" in maternal-fetal medicine? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Changes in care associated with the introduction of a postpartum hemorrhage patient safety program. [2019]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Maternal and neonatal data collection systems in low- and middle-income countries: scoping review protocol. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Under-reporting of maternal and perinatal adverse events in New Zealand. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Standardizing case definitions for monitoring the safety of maternal vaccines globally: GAIA definitions, a review of progress to date. [2023]