Heart Health Interventions for Black Maternal Health

Overseen By Jane F Cruice, RN, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Age <18, Non-Black, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 18 months

432 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial addresses heart health challenges faced by Black women during pregnancy. It tests two approaches: one focuses on home blood pressure monitoring and lifestyle changes, while the other includes community support such as doula care and mental health services. The goal is to reduce heart problem risks through personalized support. Black women who are less than 24 weeks pregnant and have high blood pressure or a BMI over 30 might be suitable candidates. Participants must also own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart health care for Black women during pregnancy.

Do I need to stop my current medications to join the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Change of Heart (COH) program, which involves home blood pressure monitoring and lifestyle changes, is generally safe. However, it can occasionally cause ovarian hyperstimulation syndrome (OHSS), a condition where swollen ovaries lead to symptoms like pain and bloating. OHSS is rare and typically associated with certain fertility treatments.

For the Change of Heart Plus (COH+) program, which includes COH and additional support services, specific information about side effects or safety issues is not yet available. This indicates that it is still under study. The "Not Applicable" label suggests an early study stage, so safety information may be limited.

Overall, COH is generally well-tolerated with some known risks, while COH+ is still under investigation for safety. Participants should consider these factors and consult their healthcare providers to understand any potential risks better. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these heart health interventions for Black maternal health because they offer a comprehensive approach that goes beyond traditional treatments. The Change of Heart (COH) program combines home blood pressure telemonitoring with personalized nutrition and physical activity guidance, plus anti-racism training for healthcare providers, aiming to create a supportive and respectful care environment. Meanwhile, the Change of Heart Plus (COH+) enhances this by adding interpersonal support, such as community doula care, mental health services, and lactation support, specifically by Black women for Black women. This holistic approach addresses both individual health and systemic issues, offering a more tailored and culturally responsive solution than standard care options.

What evidence suggests that this trial's treatments could be effective for reducing perinatal cardiovascular disease risk factors among Black women?

This trial will compare two interventions: Change of Heart (COH) and Change of Heart Plus (COH+), both aimed at reducing heart disease risks for Black women during and after pregnancy. Participants in the COH arm will receive support to manage weight and activity through home blood pressure monitoring and personalized health tips, along with training for healthcare providers to ensure respectful care. Participants in the COH+ arm will receive all components of COH plus additional support, such as community doulas, mental health services, and breastfeeding help. Both programs aim to improve heart health by combining proven individual and community strategies. Early research suggests these methods effectively manage blood pressure and other heart health factors. ^{1 4 6 7 8}

Who Is on the Research Team?

Sharon J Herring, MD, MPH

Principal Investigator

Temple University, Philadelphia, Pennsylvania, United States, 19140

Are You a Good Fit for This Trial?

This trial is for Black or African American women over 18 years old who are less than 24 weeks pregnant, have a BMI of 30 or more and/or high blood pressure. Participants must own a smartphone to join.

Inclusion Criteria

You are less than 24 weeks pregnant based on your last menstrual period.

I have a BMI of 30 or higher and/or high blood pressure.

You have a smartphone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interventions including nutrition and physical activity text messages, home blood pressure self-monitoring, and anti-racism training for providers. The COH+ group also receives community doula care, mental health services, and lactation support.

Approximately 18 months

Follow-up

Participants are monitored for changes in maternal blood pressure and body weight at six weeks and one year postpartum, along with other secondary outcomes.

12 months postpartum

Postpartum Support

Participants receive ongoing support and monitoring for emotional and informational support, breastfeeding self-efficacy, and respectful maternity care.

12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• COH
• COH+

Trial Overview The study compares two interventions aimed at reducing heart disease risk in perinatal Black women: COH and an enhanced version, COH+. It's community-driven, focusing on overcoming health disparities.

How Is the Trial Designed?

Group I: Change of Heart Plus (COH+) Experimental Treatment 1 Intervention

Includes all components of COH plus the addition of interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).

Group II: Change of Heart (COH) Active Control 1 Intervention

Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).

COH is already approved in United States, European Union, Canada for the following indications:

Approved in United States as COH for:

• Infertility
• Ovulation Induction
• Assisted Reproductive Technology (ART)

Approved in European Union as COH for:

• Infertility
• Ovulation Induction
• Assisted Reproductive Technology (ART)

Approved in Canada as COH for:

• Infertility
• Ovulation Induction
• Assisted Reproductive Technology (ART)

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 89 patients undergoing controlled ovarian hyperstimulation for IVF, those who did not take oral contraceptive pills prior to treatment (Group A) had a higher median number of retrieved oocytes compared to those who did (Group B), indicating a potential advantage of avoiding oral contraceptives before COH.

There were no significant differences in pregnancy rates, miscarriage rates, or the incidence of ovarian hyperstimulation syndrome (OHSS) between the two groups, suggesting that using oral contraceptives prior to COH may not provide clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the oral contraceptive pill on patients undergoing controlled ovarian hyperstimulation. Frederick, J., DaCosta, V., Wynter, S., et al.[2008]

In a study of 551 participants undergoing intracytoplasmic sperm injection (ICSI), higher estradiol (E2) levels on the day of human chorionic gonadotropin administration were significantly associated with better outcomes, including the number of retrieved oocytes and embryos, especially in women under 37 years old.

For women aged 37-42, higher E2 levels correlated with improved pregnancy rates and lower abortion rates, suggesting that while controlled ovarian hyperstimulation (COH) can enhance oocyte retrieval, it may also negatively impact endometrial receptivity, indicating a need for optimizing oocyte numbers rather than maximizing them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the relationship between serum estradiol levels on human chorionic gonadotropin administration day and intracytoplasmic sperm injection outcomes: A retrospective population-based study. Hajshafiha, M., Oshnouei, S., Mostafavi, M., et al.[2022]

The introduction of GnRH agonists and the use of oral contraceptives before controlled ovarian hyperstimulation (COH) have significantly improved the efficacy of in vitro fertilization treatments, primarily due to serendipitous discoveries.

Future research in COH may benefit from switching to luteinizing hormone or hCG in the final stages of treatment and utilizing new third-generation aromatase inhibitors to boost the body's natural gonadotropin production, particularly FSH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New tools for optimizing endometrial receptivity in controlled ovarian hyperstimulation: aromatase inhibitors and LH/(mini)hCG. de Ziegler, D., Mattenberger, C., Schwarz, C., et al.[2005]

A randomized study found that using only ultrasound monitoring during controlled ovarian hyperstimulation (COH) did not negatively impact pregnancy rates.

The study also showed that this simplified monitoring approach did not increase the risk of ovarian hyperstimulation syndrome (OHSS), suggesting that COH protocols could be simplified in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Monitoring ovarian stimulation: are hormonal assessments necessary?]. Rongières, C.[2013]

In a study of 198 IVF cycles, low preovulatory estradiol concentrations during controlled ovarian hyperstimulation were linked to significantly poorer oocyte and preembryo quality compared to normal or high responders (P < 0.01).

The findings suggest that low estradiol levels on the day of hCG administration may negatively impact reproductive outcomes, while high estradiol responses did not show a significant effect on IVF success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of blood concentrations of preovulatory estradiol on the quality of eggs and pre-embryos in patients treated with fertilization in vitro]. Kably Ambe, A., Barrón Vallejo, J., Tapia Lizárraga, RC., et al.[2013]

In a proof of concept study involving 11 IVF cycles, deferring the hCG rescue bolus for 3 days after oocyte retrieval resulted in significantly higher mid luteal progesterone levels in patients who received the hCG compared to those who did not (127 nmol/L vs 42.1 nmol/L).

Patients receiving the hCG bolus also showed a non-significant increase in pregnancy rates (40% vs 16.6%), suggesting that hCG luteal rescue may enhance outcomes for those at risk of severe ovarian hyperstimulation syndrome (OHSS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HCG (1500IU) administration on day 3 after oocytes retrieval, following GnRH-agonist trigger for final follicular maturation, results in high sufficient mid luteal progesterone levels - a proof of concept. Haas, J., Kedem, A., Machtinger, R., et al.[2021]

Controlled ovarian hyperstimulation (COH) protocols vary widely across the globe, influenced by factors such as country, demographics, and funding, highlighting the need for individualized treatment plans to optimize outcomes.

Despite advancements in assisted reproductive technologies, many COH protocols still lack high-quality evidence-based data, indicating a gap in research that could improve efficacy and safety in achieving healthy singleton live births.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best protocol for controlled ovarian hyperstimulation in assisted reproductive technologies: fact or opinion? Polat, M., Bozdag, G., Yarali, H.[2014]

Controlled ovarian hyperstimulation (COH) has become a standard practice in in vitro fertilization (IVF) to increase the number of oocytes retrieved, enhancing the chances of successful fertilization.

The introduction of exogenous gonadotropins marked a significant advancement in IVF, leading to the first successful clinical applications and improving overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of controlled ovarian hyperstimulation (COH) in clinical in vitro fertilization: the role of Georgeanna Seegar Jones. Jones, HW.[2008]

Using a mild starting dosage of r-FSH (75-150 IU) for ovarian stimulation in IVF/ICSI led to significantly higher implantation, clinical pregnancy, and live birth rates compared to a conventional dosage (150-225 IU), despite retrieving fewer oocytes.

The mild dosage approach also resulted in lower total r-FSH usage and costs, without increasing the risk of complications like ovarian hyper-stimulation syndrome or ectopic pregnancy, indicating a safer and more cost-effective strategy for normal ovarian responders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild starting dosage ovarian stimulation combined with a modified prolonged GnRH-a protocol improved IVF/ICSI outcomes in normal ovarian responders. Tian, LF., Tan, J., Zou, Y., et al.[2022]

Citations

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Heart Health Interventions for Black Maternal Health Trial Overview The study compares two interventions aimed at reducing heart disease risk in perinatal Black women: COH and an enhanced version, COH+. It's ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10935705/

Change of HeART: Cardiovascular Implications of Assisted ... ARTs, and especially controlled ovarian stimulation, have been associated with an increased pregnancy and short-term CV risk, although the long-term CV ...

3. trialstoday.org trialstoday.org/trial/NCT05499507

The Path to Optimal Black Maternal Heart Health The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART) · Purpose · Conditions.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0015028220303320

Ovarian hyperstimulation syndrome after assisted ... In twin pregnancies, OHSS was associated with an increased risk of second-trimester loss (aRR 1.81), low birth weight (aRR 1.06), and preterm delivery (aRR 1.16) ...

5. clinconnect.io clinconnect.io/trials/NCT01403688

Effects of Controlled Ovarian Hyperstimulation (COH) Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, ...

6. reporter.nih.gov reporter.nih.gov/search/g9f5-vFzzECWGKff739w4Q/project-details/10675067

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05499507/the-path-to-optimal-black-maternal-heart-health-comparing-two-cvd-risk-reduction-interventions-change-of-heart

The Path to Optimal Black Maternal Heart Health The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART). Last updated: December 2 ...

8. asrm.org asrm.org/practice-guidance/practice-committee-documents/prevention-and-treatment-of-moderate-and-severe-ovarian-hyperstimulation-syndrome-a-guideline/

Prevention of moderate and severe ovarian ... This systematic review aims to identify who is at high risk for developing ovarian hyperstimulation syndrome, along with evidence-based strategies to prevent ...