Heart Health Interventions for Black Maternal Health
Recruiting in Palo Alto (17 mi)
Overseen bySharon J Herring, MD, MPH
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Temple University
Disqualifiers: Age <18, Non-Black, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.
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 controlled ovarian hyperstimulation (COH) generally safe for humans?
How is the treatment COH+ unique for heart health interventions in Black maternal health?
COH+ is unique because it involves controlled ovarian hyperstimulation, a process typically used in fertility treatments to stimulate the ovaries to produce multiple eggs. This approach is novel for heart health interventions, as it is not a standard treatment for this condition, and its application in this context may involve different mechanisms or benefits not yet fully understood.36789
Eligibility Criteria
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 am 18 years old or older.
I have a BMI of 30 or higher and/or high blood pressure.
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Trial Timeline
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
Treatment Details
Interventions
- COH (Behavioral Intervention)
- COH+ (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Change of Heart Plus (COH+)Experimental Treatment1 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 Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Temple University/Temple HealthPhiladelphia, PA
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Who Is Running the Clinical Trial?
Temple UniversityLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Mild starting dosage ovarian stimulation combined with a modified prolonged GnRH-a protocol improved IVF/ICSI outcomes in normal ovarian responders. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">Controlled ovarian hyperstimulation (COH) is essential for artificial reproduction technology (ART). This study aimed to evaluate the effects of a mild starting dosage of r-FSH ovarian stimulation after the modified prolonged GnRH-a down-regulation protocol for COH on the clinical outcomes in normal ovarian responders undergoing in vitro fertilization/intracytoplasmic sperm injection-embryo transfer (IVF/ICSI-ET).
Best protocol for controlled ovarian hyperstimulation in assisted reproductive technologies: fact or opinion? [2014]From the early ages of assisted reproductive technologies (ARTs), different protocols have been developed with different gonadotropin preparations at different dosages with or without gonadotropin releasing hormone agonist or antagonist cotreatment. Various adjuvants have also been incorporated in controlled ovarian hyperstimulation (COH) protocols in an attempt to increase the efficacy and safety. The "best" protocol for COH should minimize stimulation burden while maintain the highest healthy, singleton, term live birth rates. Understandably, the one that meets all these expectations may not exist and COH should be individualized. Currently, there are worldwide differences in COH protocols and gonadotropin dose algorithms used depending on the country, demographics, funding stream, and existing guidelines/legislations. In 2014, despite efforts to individualize COH, currently, many of the protocols employ lack of high-quality evidence-based data. The aim of this review is to overview the efficacy and safety of available COH protocols, in normal responders, poor responders, and hyperresponders from evidence-based medicine perspective.
Effect of the oral contraceptive pill on patients undergoing controlled ovarian hyperstimulation. [2008]This is a retrospective analysis of 89 patients who were undergoing controlled ovarian hyperstimulation for in vitro fertilization and embryo transfer in the Fertility Management Unit of the Department of Obstetrics, Gynaecology and Child Health, The University of the West Indies. Twenty-eight patients (Group A), who did not receive oral contraceptive pills prior to controlled ovarian hyperstimulation (COH) were compared with 61 patients in Group B treated with oral contraceptive pills for two months prior to undergoing COH assisted reproduction using the long protocol. The number of follicles, oocytes, estimated oestradiol levels on the day of administration of human chorionic gonadotrophin (hCG), pregnancy rates, miscarriage rates and the incidence of patients who developed ovarian hyperstimulation syndrome (OHSS) were the main outcome measures. The mean age and haematocrit were the same in each group. The number of follicles retrieved tended to be higher in Group A than in Group B (median 8 versus 6, p = 0.06) with significantly more oocytes being retrieved in Group A than Group B (p
[Monitoring ovarian stimulation: are hormonal assessments necessary?]. [2013]Standard monitoring of controlled ovarian hyperstimulation (COH) includes hormone assays (estradiol, LH, progesterone) and regular pelvic ultrasound examination. We report a randomized study on an attempt to simplify monitoring of COH. Ultrasound monitoring of the cycle alone did not affect pregnancy rates and did not increase the risks of OHSS. These results encourage the future simplification of stimulation protocols.
[Effect of blood concentrations of preovulatory estradiol on the quality of eggs and pre-embryos in patients treated with fertilization in vitro]. [2013]The objective was to investigate if the preovulatory estradiol concentrations obtained during controlled ovarian hyperstimulation (COH) have effect on reproductive outcome. The study included a total of 198 in vitro fertilization (IVF) cycles. Patients were divided into four groups according to serum preovulatory estradiol concentrations. In low responder patients was observed significantly decreased oocyte and preembryo quality compared with normal or high responders (P
New tools for optimizing endometrial receptivity in controlled ovarian hyperstimulation: aromatase inhibitors and LH/(mini)hCG. [2005]In the long history of controlled ovarian hyperstimulation (COH), two steps stand out as being the most important ones for providing the high efficacy of current treatments: the introduction of GnRH agonists for the prevention of premature ovulation and the widespread use of pretreatment with oral contraceptives before COH for in vitro fertilization. Interestingly, the benefits of both measures resulted largely from pure serendipity, as the discovery of these advantages was mostly fortuitous and/or unintended. Today, we believe that two areas of research have the highest potential for further improving the efficacy of COH: (1) switching the follicle-stimulating hormone stimulus to that of luteinizing hormone (or small amounts of hCG) in the last stages of COH; and (2) using the benefit of the new third-generation aromatase inhibitors that have recently become available. The effects of the latter products are to enhance the endogenous production of gonadotropins (mostly FSH). This article reviews the background data and rationale that justifies each of these two new developments and summarizes data currently available.
The use of controlled ovarian hyperstimulation (COH) in clinical in vitro fertilization: the role of Georgeanna Seegar Jones. [2008]The use of controlled ovarian hyperstimulation (COH) to recruit multiple oocytes is now common practice worldwide in most clinical programs of in vitro fertilization (IVF). It was not always so. This is the story of the first successful use of exogenous gonadotropins in a clinical program of IVF.
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. [2021]Controlled ovarian hyperstimulation (COH) which combining GnRH antagonist co-treatment and GnRH agonist trigger with an additional 1500 IU hCG luteal rescue on day of oocytes retrieval, has become a common tool aiming to reduce severe ovarian hyperstimulation syndrome (OHSS). In the present, proof of concept study, we evaluate whether by deferring the hCG rescue bolus for 3 days, we are still able to rescue the luteal phase.
Evaluation of the relationship between serum estradiol levels on human chorionic gonadotropin administration day and intracytoplasmic sperm injection outcomes: A retrospective population-based study. [2022]The correlation between high estradiol (E2) levels induced by controlled ovarian hyperstimulation (COH) and pregnancy is controversial.