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The Birth and Beyond (BABY) study: protocol for a birth cohort study investigating the social and environmental determinants of pregnancy-related outcomes in Black American families
  1. Betty Lin1,2,
  2. Rachel R Middleton1,
  3. Bethlehem Terefe2,
  4. Allison A Appleton3,
  5. Beth J Feingold4,
  6. Tara Lynch2,
  7. Alex L Pieterse5,
  8. Rebecca Rogers2,
  9. Annabelle E Armah1,
  10. Lydia F Bierce1,
  11. Amanda M Flagg1,
  12. Sarah McCarthy6
  1. 1 Department of Psychology, College of Arts and Sciences, University at Albany, Albany, New York, USA
  2. 2 Obstetrics and Gynecology, Albany Medical Center, Albany, New York, USA
  3. 3 Department of Epidemiology and Biostatistics, School of Public Health, University at Albany, Albany, New York, USA
  4. 4 Department of Environmental Health Sciences, School of Public Health, University at Albany, Albany, New York, USA
  5. 5 Department of Counseling, Educational and Developmental Psychology, Boston College Carolyn A and Peter S Lynch School of Education and Human Development, Chestnut Hill, Massachusetts, USA
  6. 6 Department of Sociology, University at Albany College of Arts and Sciences, Albany, New York, USA
  1. Correspondence to Betty Lin; blin6{at}albany.edu

Abstract

Introduction In the USA, Black birthing people and infants experience disproportionately worse pregnancy-related health outcomes. The causes for these disparities are unknown, but evidence suggests that they are likely socially and environmentally based. Efforts to identify the determinants of these racial disparities are urgently needed to elucidate the highest priority targets for intervention. The Birth and Beyond (BABY) study evaluates how micro-level (eg, interpersonal and family) and macro-level (eg, neighbourhood and environmental) risk and resiliency factors transact to shape birth person-infant health, and underlying psychobiological mechanisms.

Methods and analysis The BABY study will follow 350 Black families (birthing parents, non-birthing parents and infants) from pregnancy through the first postpartum year, with research visits during pregnancy and at infant ages 6 and 12 months. Research visits comprise a combination of interview about a range of recent and life course stress and resiliency exposures and supports, psychophysiological (sympathetic, parasympathetic and adrenocortical) assessment and behavioural observations of parent–infant coregulatory behaviours. Spatial analyses are completed by mapping parent current and past residential addresses onto archival public data (eg, about neighbourhood quality and racial segregation). Finally, EMRs are abstracted for information about birthing parent relevant medical history, pregnancy conditions and infant birth outcomes. Analyses will evaluate the risk and resiliency mechanisms that contribute to pregnancy and birth-related outcomes for Black birthing people and their infants, and the protective role of individual, familial, cultural, and community supports.

Ethics and dissemination The BABY study has been approved by the Institutional Review Board at Albany Medical Centre. The study team consulted with local organisations and groups comprised of stakeholders and community leaders and continues to do so throughout the study. Research results will be disseminated with the scientific and local community as appropriate.

  • Pregnancy
  • Stress, Physiological
  • EPIDEMIOLOGIC STUDIES
  • Health Equity
  • MENTAL HEALTH
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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • Prospective longitudinal study that follows Black families from pregnancy through the first postpartum year.

  • Research visits are completed during pregnancy, and when infants are 6 and 12 months old.

  • Research visits comprise a combination of interview, psychophysiological assessment and behavioural observations of parent–infant interactions.

  • Data are also collected using spatial analyses of past and current neighbourhood characteristics and electronic medical record abstraction of relevant pregnancy and birth information.

Introduction

In the USA, Black individuals experience disproportionately worse health outcomes beginning the moment they are born. Black infants are twice as likely to be born preterm or low birth weight as White infants and are 2–3 times more likely to die within the first postnatal year compared with their non-Black counterparts.1 Likewise, Black birthing people are 1.5–4 times more likely to die compared with their non-Black counterparts.2 Elevated rates of preterm birth and low birth weight contribute to disparities for Black infants,1 and elevated rates of prenatal cardiovascular conditions contribute to disparities for birthing-related mortality.3 These racial disparities persist regardless of birthing people’s sociodemographic risks and emerge only among Black birthing people who were born in or immigrated early to the USA.4 In other words, something about growing up as a Black birthing person in the USA appears to undermine birthing person and infant (henceforth BP-infant) health.

Consistent with the suggestion that a person’s experiences may influence BP-infant health, extensive literature has now linked various forms of early life stress to poorer birth and infant health concerns, as well as cardiovascular disease in adults.5 Early life stress may influence BP-infant health by way of developmental programming, whereby exposure to acute or repeated stressors during periods of heightened developmental plasticity—including the fetal period—enacts enduring alterations to BP-infant stress physiology in ways that heighten long-term vulnerability for disease.6 Literature investigating the mechanistic role of stress physiology in Black BP-infant health is scant. Additionally, this research has focused on birthing people’s prenatal psychosocial stressors to the exclusion of racially salient stressors (eg, structural racism and interpersonal discrimination) despite their insidious health implications.7 Furthermore, nascent research suggests that exposures across the life course may influence birthing people’s stress physiology and BP-infant health8—exposures that may be of particular relevance for Black birthing people given the pervasiveness of race-related stressors over time.9 10 Finally, the over-reliance of extant research on between-group comparisons has impeded progress in identifying the most salient risk and resiliency processes for Black families. Efforts to elucidate within-group risk and resiliency processes are critical for informing the development of culturally responsive prevention and intervention efforts.

To address these questions, the Birth and Beyond (BABY) study aims to test the hypothesis that a Black birthing person’s exposure to multilevel stressors and promotive factors across the life course may alter their stress physiology in ways that have intragenerational and intergenerational consequences for their and their infant’s health (see conceptual model in figure 1). Specific aims are to:

  1. Determine the intragenerational and intergenerational consequences of birthing people’s prenatal and life course exposure to multilevel (eg, psychosocial and environmental) stressors and resiliency factors for Black BP-infant birth and health outcomes.

  2. Evaluate birthing person and infant physiological stress dysregulation (ie, adrenocortical and autonomic) as a key contributor to BP-infant birth and health outcomes.

  3. Evaluate non-birthing parent/romantic partner support as a resiliency factor that can promote BP-infant health both during pregnancy and postpartum.

Figure 1

Conceptual model. BP, birthing parent; NBP, non-birthing parent.

Methods and analysis

Participants and recruitment

The BABY study is a prospective longitudinal study funded by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD). The BABY study will follow 350 Black birthing people and their infants from pregnancy through infant 12 months of age; non-birthing parents and/or romantic partners are also invited to participate.

Recruitment for the BABY study began in August 2021 and is ongoing at the time of this publication. Participants are recruited through the prenatal care clinic at a major regional hospital in upstate New York and the surrounding community. Patients who initiate prenatal care at the clinic are prescreened for eligibility. Eligibility criteria are self-identification as Black or African American, English proficiency, minimum 18 years old, pregnant at the time of recruitment, anticipated singleton pregnancy and delivery at the participating hospital. When potentially eligible patients present for prenatal care, the patient’s medical team informs them that they may be eligible and invites them to speak with a project coordinator or research assistant onsite to learn more about study participation, verify eligibility and schedule a first research visit. In addition to clinic-based recruitment, study flyers are posted throughout the prenatal clinic waiting room, examination rooms, hospital, surrounding community and online. Those who are interested can contact study staff via phone, text, or e-mail, or can complete a contact form through the study website.

Birthing people who schedule their first research visit are also asked for permission to contact the non-birthing parent or current romantic partner (henceforth ‘non-birthing parent’ for shorthand). Once a birthing person has provided permission to contact, as well as contact information for the child’s non-birthing parent, a study team member calls the non-birthing parent to inform them of their potential eligibility to participate and share what study participation entails. Non-birthing parents are eligible if they are the biological parent, parental figure and/or if the birthing parent identifies them as their current romantic partner. Interested non-birthing parents are scheduled for a first visit during the prenatal period.

Retention strategy

To reduce drop-out rates, participants are asked to verify their contact information during phone calls approximately 1, 3 and 9 months after birth. Participants receive $5 at the next visit for each completed phone call. In addition, participants are asked for permission to contact friends/family for updated contact information in the event of lost contact. Finally, at each visit, participants are provided small gifts (eg, tote bag, bibs and water bottles) with study logos.

Procedures

Data are obtained during home visits during pregnancy, and when infants are 6 and 12 months old. Participants who do not wish to complete visits in their home, or who live more than 50 miles away from the prenatal clinic, are invited to complete visits in a private room at the clinic. All visits are conducted by an interviewer and research technician. Visits with birthing and non-birthing parents are scheduled and completed independently to (1) encourage birthing person’s participation irrespective of non-birthing parent’s participation and (2) maintain the comparability of visits for birth people whose counterparts do and do not participate in the study. Following informed consent, a trained research technician sets up and explains the purpose of the physiological equipment. Thereafter, the research technician collects the first set of blood pressure recordings and saliva samples. All other physiological information is assessed continuously during the parent–infant activities described below. The visit flow is depicted in figure 2.

Figure 2

Research visit flow. DBP/SBP, diastolic and systolic blood pressure; GSR, galvanic skin response.

Parent and infant activities

An overview and brief descriptions of parent–infant activities at each timepoint are presented in table 1. At the prenatal timepoint, parent activities involve a baby cry task and discrimination recall. When participants provide permission, the neutral and discrimination recalls are audio recorded for later coding. Pregnant people with forms of stress dysregulation are thought to show distinctive psychophysiological responses to the cry task,11 and the discrimination recall has been found to elicit distinctive patterns of physiological responsivity among Black women of reproductive age.12

Table 1

Parent–infant activities

At the 6 month timepoint, infants complete a series of standardised activities from the Laboratory Assessment of Temperament and Behaviour (Lab-TAB13 14) and the still-face paradigm.15 The activities from the Lab-TAB are designed to elicit infant reactivity and regulation. The still-face paradigm is used to assess parent–infant coregulatory behaviours and relationship quality. At the 12 month timepoint, infants again complete a series of activities from the Lab-TAB, followed by a parent–infant separation task.16 Lab-TAB tasks at the 12 month timepoint are likewise designed to elicit infant reactivity, and the separation task is used to assess parent–infant coregulatory behaviours and relationship quality.

Across all parent–infant activities, infants are seated in a study provided highchair next to their parent. Tasks are discontinued if infants cry loudly for 30 s, or at parents’ request—whichever comes first. Thereafter, parents are given time to soothe infants before proceeding onto the next task. When participants provide permission, parent–infant activities are video recorded for later behavioural coding.

Physiological assessment

Physiological data are evaluated using a combination of continuous electrocardiogram (EKG) and galvanic skin response (GSR) monitoring, blood pressure assessments and saliva samples. EKG and GSR data are recorded using ambulatory MindWare Mobile Impedance Cardiograph (Mindware Technologies, Ohio, USA). Following informed consent, a research technician places EKG electrodes on the abdomen in a standard 9-lead configuration,17 and two GSR electrodes on the palm of the participants’ non-dominant hand or pad of infants’ foot. When both a parent and infant are present (ie, during the 6 and 12 month visits), two separate MindWare mobile devices are used. EKG and GSR activity is monitored and recorded from a laptop running BioLab V.3.1.0.

Blood pressure assessments are completed using a General Electric Carescape V.100 (GE Medical Systems, Berkshire, UK). Blood pressure readings are collected in 1 min intervals before and after the parent–infant activities. At the prenatal visit, blood pressure readings are additionally collected every 1 (for 2 min tasks) or 2 (for 5 min tasks) min throughout parent activities. Saliva samples are obtained four times during each visit. The first sample is obtained before parent–infant activities begin. The remaining three samples are taken 0, 20 and 40 min after the activities are completed. For each saliva sample, parents are asked to chew on a SalivaBio cotton swab (Salimetrics, LLC, California, USA) for 2 min. Infant samples are collected by a research technician who applies the swab to the infant’s tongue, cheeks and gums. Parents and infants are asked to refrain from eating or drinking within 30 min of the visit to avoid sample contamination. Saliva samples are frozen immediately after the visit for later analysis.

Interview

Following parent–infant activities, participants complete the interview portion of the visit (see measures below; also see table 2). The first half of the interview is completed orally with supplemental visual response aids. To minimise potential concerns about literacy, participants are given the option to complete the second half of the questionnaires themselves or have the interviewer continue to administer the questionnaires orally. Except where otherwise noted, all measures are administered to both birthing and non-birthing parents. Birthing people are compensated up to $80 for each visit, and non-birthing parents up to $60 for each visit.

Table 2

Measures

Measures

Life course risk and resiliency exposures

Life course exposures

Child adversity is indexed prenatally using the Stressful Life Events Questionnaire,18 19 which assesses lifetime exposure to events that meet diagnostic criterion as ‘potentially traumatic’, and ages at which events occurred. Child subjective and objective socioeconomic status is assessed using the Childhood Experiences interview from each of 0–18 years.20 Child social environment is assessed using an adapted version of the Parent Social Participation Scale,21 and measures the degree of social and community contacts (eg, with friends and family, religious groups and organisations) participants had across childhood.

Discriminatory experiences

While birthing people of any gender are welcome to participate, we nevertheless consider that discriminatory experiences occurring at the intersection of race and (perceived) feminine gender may also be salient contributors to BP-infant health. Interpersonal experiences of racism and sexism are indexed using the Schedule of Racist Events (SRE22) and Schedule of Sexist Events (SSE23). The SRE and SSE assess the frequency of race and gender-based discrimination, respectively, in the past year and across one’s life. Microaggressions are indexed using the Gendered Racial Microaggressions Scale,24 which assesses subtle and everyday verbal, behavioural and environmental expressions may have experienced in the last year and across the lifespan. Participants can indicate that questionnaires do not apply as they see fit. The Self-Rated Skin Tone asks participants’ to evaluate their skin tone from a colour palette, which has also been linked to discriminatory experiences.25

Recent stress and distress

Various forms of recent stress are assessed, including objective and subjective experiences of stressful life events (Life Events Checklist26 27), general perceived stress (Perceived Stress Scale-428) and economic hardship (Economic Hardship Scale29). Pregnancy-related stressors are assessed using the Revised Prenatal Distress Questionnaire (nuPDQ30), which captures pregnancy-specific worries, and the Quality of Prenatal Care Questionnaire,31 which indices satisfaction with provider information sharing, anticipatory guidance, time, approachability, availability and support and respect. Forms of distress are also assessed, including general psychological distress and well-being using the Medical Outcome Study (MOS) mental health survey,32 depressive symptoms (Centre for Epidemiological Studies-Depression33) and general emotion dysregulation (Difficulty with Emotion Regulation Scale-Short Form34 35).

Individual resiliency factors

Black racial identity is indexed using subscales from the Multidimensional Inventory of Black Identity (MIBI36 37), including Black private racial regard (how one feels about being Black), Black public racial regard (perceptions of how others view Black people) and one’s beliefs about how Black people should live and interact with others (eg, assimilation). Additionally, the Africultural Coping Systems Inventory (ACSI38) assesses African-centred coping responses to everyday stressful situations, including cognitive/emotional debriefing, spiritual-centred coping, collective coping and ritual-centred coping. The MIBI and ACSI are not administered for non-birthing parents who do not self-identify as Black or of African descent.

Non-birthing parent and other social supports

Participants are asked about perceptions and attitudes about non-birthing parent involvement using a penny-sort interview task and several questionnaires. Specifically, the penny-sort interview task is used to measure how participants perceive their own and the other parent’s investments in their roles as (1) parents, (2) romantic partners, (3) workers, (4) social and (5) other.39 The Father Involvement Scale measures non-birthing parent engagement, accessibility and responsibility and can be used with both resident and non-resident parents.40 At the prenatal timepoint, parents are additionally asked about non-birthing parent participation in the pregnancy using six questions from the national Early Childhood Longitudinal Study-Birth Cohort study (ECLS-B41). The Role of the Father Questionnaire measures general attitudes about fathers’ and mens’ roles in child development.42 Among those who are currently partnered, relationship satisfaction is assessed using the Relationship Assessment Scale.43 Finally, the MOS Social Support Survey assesses the degree to which a participant generally feels supported emotionally, tangibly, affectionately, and socially.44

Neighbourhood factors

Participants’ subjective and objective life course and current neighborhood-level exposures to disadvantage and racial inequality are measured by mapping past and current residential addresses using Geographic Information Systems (GIS). Participants are asked to provide their current residential address and the address where they lived most of their early childhood (0–7 years), middle childhood (8–12 years) and adolescence (13–18 years) and to include as many details as possible (street number and name, city, zip code), including landmarks (schools, stores and parks) if they are unsure. Addresses are mapped using ArcGIS Pro V.3.2.2. Archival information about neighbourhood disadvantage (eg, socioeconomic disadvantage, access to quality education and environmental exposures), historical redlining and racial segregation (eg, index of concentration at the extremes) from public databases such as the US Census Bureau’s American Community Survey is assigned to participants bases on their census tract. When exact locations are unavailable, participant addresses are geocoded to the centroid of their zip code.

Birthing parent-infant health outcomes

Birthing parent pregnancy-related morbidity

Indices of severe and not severe pregnancy-related morbidity, as detailed by the American College of Obstetricians and Gynaecologists,45 are abstracted from electronic medical records (EMRs). This includes cardiovascular conditions such as myocarditis, hypertension, preeclampsia, eclampsia, anaemia and arrhythmia.

Infant birth, health and developmental outcomes

Infant birth outcomes are also abstracted from EMRs, including gestational age at birth, head circumference and birth weight and length. Infant health outcomes are assessed at 6 and 12 months, including the presence of infant common health concerns (eg, colic, cold, fever; Infant Health Questionnaire46) and quality of sleep (Infant Sleep Questionnaire47). Infant developmental outcomes are also evaluated for supplemental analyses, including infant temperament at 6 and 12 months using the Infant Behaviour Questionnaire-Revised-Short Form,48 and cognitive development at 12 months using the Bayley Scales of Infant Development-IV.49

Physiological stress dysregulation

Parents’ and infants’ stress dysregulation is assessed at the prenatal (parents only), 6 and 12 month timepoints using sympathetic nervous system (SNS), parasympathetic nervous system (PNS) and adrenocortical (ie, hypothalamic-pituitary-adrenal (HPA) axis) activity. SNS activity is indexed using pre-ejection period (PEP), electrodermal activity (EDA), cardiac output (CO) and total peripheral resistance (TPR). PEP and EDA data are obtained from the MindWare mobile devices and are indicative of β-adrenergic SNS activity. PEP represents the duration between the onset of ventricular depolarisation and the opening of the aortic valve, while EDA refers to changes in the electrical activity of the skin due to sweat released by the eccrine glands during SNS activation.50 PEP and EDA data are scored in 30 s segments using MindWare IMP or EDA analysis software V.3.2.13, and will be averaged across segments corresponding to each task.

CO and TPR are derived using heart rate and blood pressure information obtained via the GE Carescape. CO and TPR reflect α-adrenergic SNS activity; CO measures the volume of blood ejected from the heart and TPR measures vascular resistance to blood flow. Blood pressure and HR will be averaged for each task, and average levels will be used to compute CO and TPR using previously validated formulas.51 CO and TPR stress reactivity scores will be used to determine participants’ haemodynamic profile (HP; degree of vascular or myocardial stress reactivity) and compensation deficit (CD; vascular regulation inefficiency) following Gregg et al’s HP-CD model.52–54

PNS activity is indexed using High Frequency Heart Rate Variability (HF-HRV) which is abstracted from EKG data obtained using the MindWare mobile device. HF-HRV measures the influence of the PNS on the heart that occurs at the frequency of respiration.55 EKG data are scored in 30 s segments using MindWare HRV analysis software V.3.2.13. HF-HRV is then averaged across segments for each task. HPA axis activity is assessed through salivary cortisol administered across four time points at each visit to capture the protracted time frame of cortisol reactivity.56 Saliva samples will be shipped to a laboratory where each sample is assayed for free cortisol. Efforts are made to schedule all visits during one of four-time blocks (ie, 9 AM, 1 PM, 3 PM and 6 PM) due to the diurnal rhythm of cortisol; time of sampling will be entered as a covariate.

Behavioural observations of parent–infant coregulatory behaviours

Parent coregulatory behaviours during parent–infant activities at 6 and 12 months are rated by trained observers using a behavioural rating system based on the rating scales from the NICHD Study of Early Child Care and Youth Development (SECCYD57 58). Global qualitative ratings of parent sensitivity to non-distress, intrusiveness and positive regard/delight will be coded on a 5-point scale (1=not at all characteristic; 5=highly characteristic) and averaged across tasks. Trained observers are trained to 70% agreement within ±1 point and 85% exact agreement, and ongoing reliability meetings are held with a lead coder to minimise coder drift.

Demographics and potential covariates

Extensive information about demographics or potential covariates are obtained using self-report and medical record abstraction (eg, age, education, employment, income, nativity, ethnicity, gender, sex, sexual identity, family and household characteristics, etc). These variables provide contextual information regarding the study sample and will be considered as potential covariates or moderators in analyses as relevant. Sensitivity analyses will be run excluding participants with premorbid medical and psychiatric conditions or other potential outliers (eg, age) where appropriate.

Data analysis

Analyses for primary study aims will be addressed using SPSS and Mplus. Proposed analyses are detailed here, but actual analyses may deviate when indicated (eg, in accordance with best practice, such as via statistical or theoretical advancements). To address the first aim, we will evaluate patterns of multilevel childhood stress and resiliency exposure using information obtained from both birthing and non-birthing parents, such as using latent profile analysis (LPA). Using patterns obtained from pooled analyses, we will then test whether birthing people’s childhood stress and resiliency exposures are differentially associated with birthing parent health, infant birth outcomes and infant postnatal health concerns, such as using the BCH method (akin to analysis of variance) in Mplus. Multiple linear regressions will test direct and interactive effects of prenatal stress and childhood stress on BP-infant outcomes. Multiple linear regressions will also test the protective role of birthing parent resiliency factors (eg, strong Black racial identity, adaptive coping and high social support) on BP-infant health over and above the effects of childhood stress.

With respect to the second aim, we operationalise physiological stress dysregulation via consistency with the cardiovascular conundrum (CC59). The CC is a physiological phenomenon characterised by opposing patterns of physiological activity across stress response systems (simultaneous upregulation and downregulation across systems, eg, SNS and PNS activation, vascular reactivity, vascular regulation inefficiency and excess cortisol reactivity) that has been observed in marginalised populations,50 and is thought to underlie stress-health disparity links. The CC is also thought to correspond with lower resting levels of PNS activity,60 and higher resting SNS and HPA activity.61 Multiple linear regressions will test associations between birthing parent prenatal physiological dysregulation and BP-infant health. Also, a mediation model will test whether birthing parent physiological dysregulation is associated with infant physiological dysregulation at 6 months and subsequent infant health concerns at 12 months.

To test the third aim that non-birthing parent support can promote BP-infant health, a multivariate regression will test the associations between non-birthing parent supports (ie, physiological regulation and social support) on BP-infant health. Additionally, a multiple regression will test associations between non-birthing parent coregulatory support (behavioural and physiological) on infant physiological regulation over and above birthing parent coregulatory support. Missing data will be addressed by screening data for missing data patterns and implementing full-information maximum likelihood.

The target sample size (n=350) was determined via estimated sample size needed for the LPA proposed in aim 1, as these analyses required the largest sample size to achieve 80% power across proposed analyses. Importantly, power for an LPA depends on the number of profiles and the magnitude of difference between profiles (distance), but neither can be determined until after LPA have been run. Nevertheless, simulation studies by Tein et al 62 have demonstrated that LPA with a distance of Cohen’s d=0.8, a commonly met criterion among existing LPA studies, a sample size of 500 participants (ie, including both birthing and non-birthing parents) with 15 indicators (eg, of life course risk and resiliency exposures) is usually adequately powered to detect the correct number of classes. Although we do not know how many non-birthing parents will participate, we projected that if even half of non-birthing parents participated (n=175), we would be adequately powered for the LPA (pooled n=525).

Ethics and dissemination

The study was approved by the Institutional Review Board at Albany Medical Centre (#5590). All participants provide verbal informed consent to participate before we schedule our first research visit. At the first research visit before research activities begin, participants also provide written consent for themselves and assent for their infants to participate. Participants have the right to withdraw from the study at any point and can request to have their data removed if they would like. Participation, or lack thereof, in this research does not affect medical care. Results from this study will be disseminated with the scientific community via conferences and publications, as well as with the local community and hospital systems as deemed appropriate via consultation with community leaders and stakeholders such as discussed below.

Patient and public involvement statement

Investigators and study team members have been consulting with various community leaders and stakeholders at various stages throughout the design and implementation process, including a local task force comprising community leaders and stakeholders interested in advancing health equity in the local area, and a Birth Place Advisory Committee (BPAC) comprised of birthing people who gave birth at the hospital where patients were recruited. Additionally, the study is continuing to engage and partner with local organisations and community groups with shared interests in birth justice, such as for sharing resources and advertising research staff positions among trusted community members.

Ethics statements

Patient consent for publication

References

Footnotes

  • X @AmandaMFlagg

  • Contributors BL contributed to initial conception and design of the study, and BL, AAA, BJF, ALP, TL and RR helped to refine the conceptualisation and design, secure funding and implement the study. RRM and BT helped coordinate study implementation. RRM, BT, AEA, AMF and LFB contributed to data collection and processing, and SM to data processing. BL, RRM and BT drafted this initial manuscript, and all authors have critically reviewed and approved the final version.

  • Funding This work is supported by NICHD R01HD106913. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

  • Competing interests RR receives royalties from Uptodate.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.