Enhanced Postpartum Visits for New Mothers

Overseen By Kimberly Jones-Beatty, CNM, DNP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Fetal demise, Non-Medicaid insurance, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve postpartum care for new mothers with high blood pressure during pregnancy or diabetes. It tests whether regular visits to an obstetric care provider in the first year after childbirth can prevent future health problems. Participants will either attend structured postpartum visits with a care provider or assessment visits with a nurse at 3, 6, and 12 months after giving birth. Those who have experienced pregnancy-related high blood pressure or diabetes and plan to continue care at the University of Maryland Medical Center are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance postpartum care for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these postpartum visits are safe?

Research has shown that structured postpartum visits are safe and well-received by new mothers. These visits improve attendance and health outcomes, particularly for mothers with high blood pressure. For instance, one study found that home blood pressure monitoring helped mothers attend follow-up visits and maintain blood pressure control. Another study found that postpartum care tailored to each mother's needs can improve long-term health and reduce the risk of future heart problems.

These structured visits aim to manage and reduce the risks of common postpartum issues like high blood pressure and diabetes. The focus is on ongoing, personalized care, which has proven safe and effective in improving mothers' health after childbirth. Overall, these findings suggest that enhanced postpartum visits offer a safe and beneficial approach for new mothers, especially those at higher risk of health problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more structured approach to postpartum visits, aiming to better address and manage hypertensive and diabetes disorders in new mothers. Unlike standard postpartum care, which often varies in frequency and focus, this intervention includes scheduled, targeted visits at 3, 6, and 12 months. These visits not only focus on managing existing conditions but also work proactively to reduce the risk of developing them. By integrating a comprehensive approach to postpartum and primary care concerns, this method holds the potential to significantly improve maternal health outcomes.

What evidence suggests that enhanced postpartum visits are effective for reducing maternal morbidity and mortality?

This trial will compare enhanced postpartum visits with standard postpartum care. Studies have shown that more frequent postpartum check-ups can significantly improve the health of new mothers, particularly those with high blood pressure or diabetes after childbirth. For instance, research indicates that a clinic system using electronic medical records aids in managing high blood pressure after pregnancy, resulting in better follow-up care and long-term heart health. One study found that home blood pressure monitoring increases attendance at postpartum visits and controls blood pressure more effectively than less frequent checks. Evidence also suggests that better blood pressure control can reduce emergency visits after childbirth. Overall, regular and organized postpartum visits appear to help manage these conditions and lower future health risks. ^{1 2 6 7 8}

Who Is on the Research Team?

Jenifer Fahey, CNM, PhD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for new mothers in the first year after giving birth, especially those who had high blood pressure or pre-eclampsia during pregnancy. It aims to improve their long-term health by changing how postpartum care is given.

Inclusion Criteria

I was diagnosed with high blood pressure or diabetes before leaving the hospital after giving birth.

I am covered by Medicaid insurance.

Pregnant individuals planning to deliver and continue postpartum care at the University of Maryland Medical Center

Exclusion Criteria

I have health insurance that is not Medicaid.

I have never been diagnosed with high blood pressure or diabetes.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive structured postpartum visits at 3, 6, and 12 months with obstetric care providers to manage hypertensive and/or diabetes disorders

12 months

3 visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure and glucose level assessments

12 months

Regular monitoring at 6 weeks, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Postpartum Visits

Trial Overview

The study tests whether ongoing, personalized postpartum care by obstetric providers can better prevent health issues than the traditional single visit at six weeks after childbirth.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention group will have scheduled structured postpartum visits at 3, 6, and 12 months with obstetric care providers. These structured visits will be targeted at both managing current hypertensive and/or diabetes disorders and decreasing the risk of developing these disorders. Additional postpartum and primary care concerns will also be addressed as they arise.

Group II: Control Active Control 1 Intervention

The control group will have study assessment visits at 3, 6, and 12 months during the first postpartum year, conducted by a Registered Nurse (RN).

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

A randomized controlled trial involving 116 women, primarily Latina immigrants, demonstrated that both a co-located 'mommy-baby visit' and enhanced usual care significantly increased postpartum visit attendance rates to 94%, compared to historical controls at 69.7%.

The study suggests that providing postpartum appointment scheduling assistance before hospital discharge is an effective, low-cost strategy to improve attendance at postpartum visits, regardless of the type of visit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Postpartum Gap: A Randomized Controlled Trial to Improve Postpartum Visit Attendance Among Low-Income Women with Limited English Proficiency. Polk, S., Edwardson, J., Lawson, S., et al.[2021]

The postpartum navigation program, Navigating New Motherhood, significantly improved attendance at postpartum visits, with 88.1% of participants returning for care compared to 70.3% in the historical cohort, indicating a strong impact on follow-up care.

Women in the navigation program also showed increased uptake of contraceptive methods, postpartum depression screening, and vaccinations, suggesting that the program not only enhanced visit attendance but also improved overall postpartum health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Patient Navigator to Improve Postpartum Care in an Urban Women's Health Clinic. Yee, LM., Martinez, NG., Nguyen, AT., et al.[2021]

A systematic review of 64 studies involving over 543,000 participants found that the location of postpartum care (clinic, home, or telephone) did not significantly impact maternal mental health outcomes like depression or anxiety, indicating that care delivery method may not be as critical as previously thought.

Providing contraceptive care earlier after childbirth was linked to a higher use of contraceptive implants at 6 months, suggesting that timely access to contraceptive services can improve family planning outcomes for new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery Strategies for Postpartum Care: A Systematic Review and Meta-analysis. Saldanha, IJ., Adam, GP., Kanaan, G., et al.[2023]

In a study of over 20 million postpartum visits, it was found that less than 50% of recommended services, such as depression screening and contraceptive counseling, were provided, highlighting a gap in postpartum care.

The study revealed that while most services were similarly provided across different insurance types, women on Medicaid received significantly fewer breast examinations compared to those with other insurance, indicating potential disparities in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Insurance Status With Provision of Recommended Services During Comprehensive Postpartum Visits. Geissler, K., Ranchoff, BL., Cooper, MI., et al.[2022]

5.7% of women experienced emergent hospital encounters within 42 days postpartum, with nearly 40% of these visits resulting in hospital admissions, which increased from 2.0% in 2015 to 3.4% in 2019.

Common reasons for these emergent visits included fever, abdominal pain, and hypertension, with hypertensive disorders, wound complications, and endometritis being the leading causes for hospital admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Gap in Care? Postpartum Women Presenting to the Emergency Room and Getting Readmitted. Patel, S., Rodriguez, AN., Macias, DA., et al.[2021]

Outpatient postpartum care should begin within three weeks after delivery and include multiple follow-ups to address both acute and chronic health needs, ensuring comprehensive support for new mothers.

Specific assessments, such as glucose tolerance tests for women with gestational diabetes and blood pressure checks for those with hypertensive disorders, are crucial within the first 12 weeks postpartum to prevent long-term health complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum Care: An Approach to the Fourth Trimester. Paladine, HL., Blenning, CE., Strangas, Y.[2020]

Only 13.7% of mothers in Wonago District utilized early postnatal care services, highlighting a significant gap in maternal health support during the critical days after delivery.

Factors such as higher educational status, attendance at antenatal care (ANC), place of delivery, complications after delivery, and previous postnatal care experience were strongly associated with increased utilization of early postnatal care, suggesting targeted interventions could improve access and use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postnatal Care Service Utilization and Its Determinants among Women Who Gave Birth in the Last 6 Months in Wonago District, South Ethiopia: A Community-Based Cross-Sectional Study. Tefera, Y., Hailu, S., Tilahun, R.[2022]

Implementing a scheduling change by adding a 2- to 3-week postpartum appointment significantly increased attendance at postpartum visits from 74% to 100% in the last month of the project, demonstrating the efficacy of early scheduling.

The average number of days to the first postpartum visit decreased from 40.7 days to 21.8 days, indicating that earlier appointments can help new mothers receive timely care after childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Project to Increase Postpartum Clinic Visits for Publicly Insured Women. Kuster, A., Lee, KA., Sligar, K.[2022]

The study reviewed 199 infant medical records to assess outcomes after early postpartum discharge, finding that while overall readmission rates were similar to previous studies, early discharge infants had a higher readmission rate than reported elsewhere.

The results highlight the importance of postpartum follow-up care and education, suggesting that adherence to discharge guidelines and effective home support can influence infant health outcomes after early discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum home visits: infant outcomes. Frank-Hanssen, MA., Hanson, KS., Anderson, MA.[2019]

The revised model of perinatal care, which included a postpartum care center and increased lactation support, led to a reduction in undesirable health events for mothers and newborns, with 45% experiencing such events compared to 52% in the traditional care model.

Mothers in the revised care group reported higher satisfaction regarding newborn care and breastfeeding support, while overall costs decreased by $149 per delivery, demonstrating that improved care can be achieved without increasing expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and maternal perceptions of an updated model of perinatal care. Lieu, TA., Wikler, C., Capra, AM., et al.[2019]

A survey of mothers in Colombo, Sri Lanka, revealed that most had positive perceptions of postnatal care quality, with a median score of 108 out of a possible 115, indicating overall satisfaction with technical and interpersonal care.

However, the lowest ratings were for ward facilities and cleanliness, suggesting that improvements in the physical environment of care settings are needed to enhance overall maternal satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client perceived quality of the postnatal care provided by public sector specialized care institutions following a normal vaginal delivery in Sri Lanka: a cross sectional study. Wickramasinghe, SA., Gunathunga, MW., Hemachandra, DKNN.[2021]

A study of 587 postpartum patients identified five key factors that increase the risk of not attending the 6-week postpartum visit, including being on Medicaid, starting prenatal care late, and being under 24 years old.

The developed risk scoring system effectively predicts nonadherence to the 6WPP, allowing healthcare providers to target interventions for at-risk patients, with significant predictive power demonstrated in both test and validation groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Clinical Risk Assessment Tool for 6-Week Postpartum Visit Nonadherence. Qafiti, F., Kaur, S., Bahado-Singh, R.[2019]

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