Monitoring System for Pregnancy Complications

(MOMS Trial)

Recruiting at 1 trial location

Overseen By Natalie Benda

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Severe cognitive impairment, major psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Pregnancy-related death is a growing public health issues, which are of particular concern to minority groups, including African-Americans and Spanish-speaking Latinas. Our proposal aims to improve a patient's ability to detect warning signs of pregnancy related death and seek medical care.

Will I have to stop taking my current medications?

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

Is the Monitoring System for Pregnancy Complications safe for humans?

The research highlights the importance of monitoring adverse events (unwanted effects) in pregnancy trials to ensure safety, but it does not provide specific safety data for the Monitoring System for Pregnancy Complications. It emphasizes the need for better safety monitoring and reporting systems to understand risks in pregnant women. ^{1 2 3 4 5}

How is the Maternal Outcome Monitoring and Support system different from other treatments for pregnancy complications?

The Maternal Outcome Monitoring and Support system is unique because it focuses on continuous monitoring and early detection of pregnancy complications, which can help prevent severe outcomes by providing timely interventions. Unlike traditional treatments that may address complications after they occur, this system aims to proactively manage maternal health through real-time data and support. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Maternal Outcome Monitoring and Support system, Pregnancy Care Monitoring System, Maternal Health Support System?

Research suggests that early warning systems in obstetric care can help reduce maternal risks by alerting healthcare providers to potential complications early on. These systems, when implemented effectively, improve coordination among medical staff and support decision-making, which can lead to better maternal safety and outcomes. ^{3 10 11 12 13}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals over 28 weeks, identifying as Black/African American or Hispanic/Latino. Participants must be able to read and speak English or Spanish respectively, plan to deliver at specified NewYork-Presbyterian hospitals, be 18+, and receive healthcare in the U.S. Those with severe cognitive issues, major psychiatric illness, or terminal illnesses cannot join.

Inclusion Criteria

I am more than 28 weeks pregnant.

Identify as Black or African American race AND able to speak and read English, AND preferred language of English OR Identify as Hispanic/Latino Ethnicity AND able to speak and read Spanish AND preferred language of Spanish

Planned delivery at the following NewYork-Presbyterian hospitals: Children's Hospital of New York, Allen Hospital, Weill Cornell Medical Center, Lower Manhattan Hospital

Exclusion Criteria

I have significant memory or thinking problems.

Major psychiatric illness

Concomitant terminal illness that would preclude participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MOMS symptom monitoring and decision support intervention

6 weeks

Ongoing monitoring via smartphone app

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maternal Outcome Monitoring and Support system

Trial Overview The trial is testing a Maternal Outcome Monitoring and Support system designed to help patients recognize warning signs of pregnancy-related complications that could lead to death, especially among minority groups.

How Is the Trial Designed?

Group I: MOMS intervention Experimental Treatment 1 Intervention

Participants in this condition will receive the MOMS symptom monitoring and decision support intervention. This is a single arm trial.

Maternal Outcome Monitoring and Support system is already approved in United States, European Union for the following indications:

Approved in United States as Maternal Outcome Monitoring and Support system for:

• Pregnancy-related care
• Maternal health monitoring

Approved in European Union as Maternal Outcome Monitoring and Support system for:

• Pregnancy-related care
• Maternal health monitoring

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Implementing obstetric early warning systems can significantly enhance maternal safety by alerting healthcare providers to potential critical illnesses, but success depends on strong administrative support and resource allocation across hospitals.

To effectively reduce maternal morbidity and mortality, early warning systems should be comprehensive, addressing a wide range of conditions, and should be complemented by specific care bundles for issues like hemorrhage and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Obstetric Early Warning Systems. Friedman, AM., Campbell, ML., Kline, CR., et al.[2020]

Maternal morbidity and mortality rates are increasing in the United States, prompting organizations to focus on improving patient safety in obstetric care.

The implementation of early warning systems and standardized patient care bundles is crucial for early intervention and preventing complications, with ongoing monitoring of outcomes through root cause analysis to enhance safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Patient Safety to Reduce Maternal Mortality. Baptiste, C., D'Alton, ME.[2019]

The study evaluated a systematized form for detecting severe maternal outcomes (SMO) in 20 maternity hospitals across Latin America, finding an incidence of 12.9 SMO and 12.3 maternal near miss (MNM) cases per 1,000 live births.

The form was highly effective, identifying 100% of MNM cases and over 99% of potentially life-threatening conditions, with specific clinical indicators like altered consciousness and oliguria showing strong predictive capacity for SMO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal near miss and predictive ability of potentially life-threatening conditions at selected maternity hospitals in Latin America. De Mucio, B., Abalos, E., Cuesta, C., et al.[2022]

Intensive care units (ICUs) can provide critical care for women experiencing severe maternal outcomes (SMO), which include near miss morbidity and maternal death, highlighting the importance of timely healthcare management.

The review assessed existing ICU clinical and obstetric prediction scores, suggesting that improving the prediction of SMO during ICU admissions could enhance obstetric care management and outcomes for mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic scores for prediction of maternal near miss and maternal death after admission to an intensive care unit: A narrative review. Silva, FX., Katz, L., Cecatti, JG.[2023]

In a study of 868 women, fetal nasal bone length measurements in the first trimester were found to be effective predictors of adverse pregnancy outcomes, particularly preterm labor and preterm premature rupture of membranes.

Specifically, a nasal bone length greater than the 95th percentile was significantly linked to preterm labor and rupture of membranes, while lengths above the 99th percentile were associated with both preterm labor and oligohydramnios, indicating its potential clinical utility in early pregnancy assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal Nasal Bone Length as a Novel Marker for Prediction of Adverse Perinatal Outcomes in the First-Trimester of Pregnancy. Canda, MT., Demir, N., Sezer, O.[2018]

A new framework for monitoring adverse events (AEs) in pregnancy trials has been developed, which includes specific definitions and severity grading for both maternal and fetal AEs, enhancing safety assessments for drugs and interventions.

The framework was created through a comprehensive literature review and consensus from an international group of experts, resulting in 12 maternal and 19 fetal AE definitions that can be systematically applied in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Spencer, RN., Hecher, K., Norman, G., 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]

This review analyzed maternal risks associated with pregnancy and childbirth, focusing on both short- and long-term outcomes, using data from large cohort studies involving 54,000 births to create an educational tool for better understanding maternal morbidity and mortality.

Key risk factors for increased maternal morbidity include advanced maternal age (over 45 years), pre-existing health conditions like hypertension or cardiac issues, and complications during pregnancy such as gestational hypertension and postpartum hemorrhage, highlighting the need for personalized pre-conception education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Real Maternal Risks in a Pregnancy: A Structured Review to Enhance Maternal Understanding and Education. Wilson, RD.[2021]

In a study analyzing the performance of five different alerting algorithms for monitoring drug safety, it was found that no single algorithm was superior across all scenarios, highlighting the need for tailored approaches based on specific product-outcome characteristics.

The algorithms successfully identified cases of rhabdomyolysis linked to cerivastatin before the drug was withdrawn, demonstrating their potential effectiveness in active medical-product-safety surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rules. Gagne, JJ., Rassen, JA., Walker, AM., et al.[2021]

The Smart Postpartum Care (SMAP CARE) system was developed to enhance early detection of postpartum issues, which is crucial for reducing maternal mortality in Indonesia, based on input from healthcare professionals and a feasibility study involving postpartum mothers.

SMAP CARE includes educational features on various aspects of postpartum care, such as physiological changes, breastfeeding, and recognizing danger signs, making it a valuable tool for both mothers and healthcare providers in community health centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Smart Postpartum Care Application Based on Community Health Centers, as a Method for Mentoring Postpartum Mothers: A Mixed Method Approach. Anggorowati, ., Sudarmiati, S., Prakoso, T.[2022]

The review identified 37 studies across 24 low-income countries that focus on measuring severe acute maternal morbidity, highlighting the challenges in defining and identifying these complications.

Information on severe acute maternal morbidity has been utilized to improve safe motherhood programs, indicating its potential as a valuable indicator for monitoring maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe acute maternal morbidity in low-income countries. Ronsmans, C.[2022]

Improving recordkeeping procedures at 10 healthcare facilities led to more consistent and timely data collection on obstetric complications, which is crucial for monitoring maternal mortality interventions.

Training healthcare staff and implementing monitoring mechanisms were key factors in the success of the improved recordkeeping system, which has the potential to be adopted by other districts in the region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving recordkeeping for maternal mortality programs, Kumasi, Ghana. The Kumasi PMM Team. Danquah, JB., Appah, EK., Djan, JO., et al.[2019]

The maternal early warning system (MEWS) was implemented in a study involving 1166 patients and successfully triggered alerts in 75 cases (6.43%), primarily due to altered systolic blood pressure, indicating its potential to monitor critical conditions post-delivery.

Despite its high specificity (94%), the MEWS showed low sensitivity (28%), resulting in a significant number of false-negatives, which suggests that while it is effective at identifying patients who are stable, it may miss some cases that require urgent attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a maternal early warning system during early postpartum. A prospective observational study. Ibáñez-Lorente, C., Casans-Francés, R., Bellas-Cotán, S., et al.[2021]

Citations

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

Implementing Obstetric Early Warning Systems. [2020]

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

Applying Patient Safety to Reduce Maternal Mortality. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Maternal near miss and predictive ability of potentially life-threatening conditions at selected maternity hospitals in Latin America. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Prognostic scores for prediction of maternal near miss and maternal death after admission to an intensive care unit: A narrative review. [2023]

5. Turkey pubmed.ncbi.nlm.nih.gov

Fetal Nasal Bone Length as a Novel Marker for Prediction of Adverse Perinatal Outcomes in the First-Trimester of Pregnancy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

The Real Maternal Risks in a Pregnancy: A Structured Review to Enhance Maternal Understanding and Education. [2021]

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

Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rules. [2021]

10. India pubmed.ncbi.nlm.nih.gov

Development of Smart Postpartum Care Application Based on Community Health Centers, as a Method for Mentoring Postpartum Mothers: A Mixed Method Approach. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Severe acute maternal morbidity in low-income countries. [2022]

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

Improving recordkeeping for maternal mortality programs, Kumasi, Ghana. The Kumasi PMM Team. [2019]

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

Implementation of a maternal early warning system during early postpartum. A prospective observational study. [2021]