Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04257552 |
| Other study ID # |
STUDY19040312 |
| Secondary ID |
1R56NR017933-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2020 |
| Est. completion date |
September 2, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The overarching hypothesis of our research agenda is that an intervention that engages
economically disadvantaged women in personalized postpartum care will promote equality in
maternal child health. As a first step to test our hypothesis the investigators propose the
following aims:
Specific Aim 1: Measure the impact of Healthy Beyond Pregnancy on key components of
postpartum care, including use of effective contraception at three and six months postpartum
and breastfeeding duration at three and six months.
Specific Aim 2: Determine if Healthy Beyond Pregnancy improves adherence to health screening
and linkage to follow-up care for women with cardio-metabolic complications of pregnancy.
Description:
There are profound economic inequalities in a wide range of important maternal and child
health outcomes ranging from neonatal death to maternal morbidity and mortality. The
overarching scientific premise for our proposal is that these inequalities stem in part from
poor engagement in postpartum care by economically disadvantaged women. The investigators
hypothesize that an innovative intervention grounded in empirically derived tenets of
behavioral economics that includes the critical components of the American College of
Obstetricians and Gynecologists (ACOG) new vision for postpartum care will narrow gaps in
important maternal child health outcomes.
Women of lower socioeconomic status are at significantly increased risk of unintended
pregnancies, short inter-pregnancy interval and short duration of breastfeeding. The
consequences of untimed pregnancies and short duration of breastfeeding for the health of
mothers, infants and children are well documented. In addition to significant health
implications, these inequalities have important economic ramifications. The cost of births
from unintended pregnancies in 2006 was estimated at $11 billion in maternity and infant
care. This does not include cost of abortion care, lost productivity, and government
assistance.
Providers have effective postpartum strategies to reduce the risk of poorly timed pregnancies
and low breastfeeding rates.
Short interval or poorly timed pregnancies: Women have a range of effective contraceptive
options, however, not initiating contraception postpartum remains common. The provision of
long-acting reversible contraception (LARC) including intrauterine devices (IUDs) and
hormonal implants has been shown to decrease short interval pregnancies and the associated
risk of preterm birth. Importantly, given the array of contraceptive options available to
women, it is important to make LARC accessible while empowering women to choose a method that
is effective and acceptable to them. This highlights the need for solutions to engage women
in patient centered comprehensive contraceptive decision-making in the postpartum period.
Short Breastfeeding Duration: A number of strategies have been shown to increase
breastfeeding success. Most relevant to our proposal is that efforts to educate women about
the benefits of breastfeeding, weekly text reminders in the immediate postpartum period, and
access to a lactation consultant have all improved both duration and exclusivity of
breastfeeding. Importantly, three recent trials demonstrated significant increases in
exclusive breastfeeding from eight weeks to six months postpartum among women who received
weekly-automated text message breastfeeding support. These interventions may be particularly
relevant to our target population, as low-income, non-Hispanic Black women between 18-29
years send and receive text messages more frequently than any other demographic.
There are important high-risk subgroups of women who benefit uniquely from postpartum care
given the need to link these women to primary or specialty health care providers in
postpartum period.
Gestational diabetes (GDM): GDM complicates roughly 6-9% of pregnancies, but
disproportionately burdens those with lower socio-economic status. Women with GDM are at
increased risk of type 2 diabetes, metabolic syndrome, and cardiovascular disease after
delivery. These findings are present as early as 3 months postpartum with the absolute risk
of Type 2 diabetes approaching 5% a year postpartum. Professional societies recommend
screening women for diabetes 4-12 weeks after delivery and linking women to primary care to
improve long-term maternal health. In 2016, only 14% of economically disadvantaged women who
received prenatal care at the Magee-Womens Hospital outpatient clinic returned for their
postpartum screening. This is slightly better than national trends, which suggest roughly 6%
of women with GDM had recommend postpartum screening and 13.8% had a primary care visit
within a year.
Hypertensive disorders of pregnancy: Hypertensive disorders of pregnancy occur in roughly
6-8% of pregnancies and low SES is an independent risk factor. Women with hypertensive
disorders of pregnancy, either gestational hypertension or preeclampsia, are more than twice
as likely to develop hypertension or prehypertension in the 12 months after delivery. They
are also at increased risk for cardiovascular disease. Given this, women with a hypertensive
disorder of pregnancy should have early postpartum follow up for a blood pressure and
establish care with a primary care physician within a year of delivery.
Recognizing the importance of the postpartum period for the health of women and children
across their lifespans, ACOG recently proposed a new paradigm for postpartum care. In their
new vision for postpartum care ACOG emphasized the following: 1) Postpartum care should be an
on-going process rather than a single encounter 2) The content of postpartum care should be
tailored to a woman's individual needs 3) The timing of the postpartum visit should be
individualized for a woman. How to implement and scale this model of postpartum care and
whether it will improve health outcomes for women and children has not been investigated.
Despite considerable maternal morbidity and mortality in the postpartum period, attendance
rates for the postpartum visit are markedly lower for women with limited resources
contributing to economic health disparities. While women with Medicaid receive excellent
prenatal care, only 50% of them return for their postpartum visit. These parallel national
trends, where 60% of women with Medicaid insurance return for a postpartum checkup compared
with over 82% of women with private insurance. Medicaid programs serve pregnant women who are
particularly vulnerable to poor health outcomes and thus this gap is critical. These data
demonstrate that our current care model does not engage all women in quality postpartum care
and is disproportionately failing our most vulnerable moms and babies.
Existing interventions to improve adherence with the postpartum visit have not been
rigorously evaluated, would be difficult to scale, and do not reflect the new vision for
postpartum care outlined by ACOG.
Empirically derived concepts from behavioral economics can be leveraged to design
interventions that support patient's engagement in their health. The field of behavioral
economics acknowledges that people do not make exclusively rational choices. In fact,
immediate (rather than future) needs, cognitive and psychological biases, and social norms
profoundly influence decision-making. Insights from the field of behavioral economics have
begun to influence the health sciences as researchers seek more effective health
interventions and health policy.
Healthy Beyond Pregnancy incorporates tenets of behavioral economics that address two
powerful drivers of behavioral change-- awareness and willingness. Awareness has three parts:
1) an awareness of how one's behavior affects oneself 2) an awareness of how one's actions
impact others and 3) an awareness of social norms around the given behavior. Awareness alone,
however, is insufficient to alter behavior. People must be willing to change their behavior.
Designing health interventions that address both awareness and willingness are more likely to
lead to behavior change.
In the current proposal the investigators focus on four tenets of behavioral
economics-bounded rationality (information overload), status quo bias (valuing the present
self over the future self), hovering (limited attention), and framed incentives-- that
address both awareness and willingness and have been successfully used to tackle stubborn
health problems such as smoking and obesity. Both bounded rationality and hovering address
awareness, while status quo bias and framed incentives address willingness.
In summary, this proposal is significant because it will evaluate the impact of an innovative
program built on empirically derived concepts of behavioral economics on health
decision-making in the postpartum period- a critical window for maternal child health. Our
program directly mirrors the new vision for postpartum care outlined by ACOG. Additionally,
it targets low-income women who are at risk for not participating in postpartum care to
promote equality in maternal child health.
