Direct Measurements of Cervical Remodeling for Predicting Preterm Birth



Status:Archived
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2009
End Date:November 2011

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Racism and health care system distrust are potent stressors and may be associated with
preterm birth (PTB). Additionally, cervical shortening is a common pathway leading to PTB.
This study is enrolling a prospective cohort of pregnant women. The study assesses racial
discrimination, health care system distrust, and cervical change using 2 questionnaires,
exam, and protein levels in cervical vaginal fluid and maternal serum.


Preterm birth (PTB) is currently the most important maternal and child health problem in the
United States. It is the leading cause of neonatal mortality and a significant contributor
to neonatal morbidity. In the United States, approximately 12% of all live births are born
preterm, an incidence that continues to rise. The extreme cost of PTB resides not only in
the immediate neonatal care but also in the longterm care of lasting morbidities resulting
from prematurity. Effective prevention or treatment of PTB could significantly lower
neonatal mortality and morbidity as well as health care costs. In the United States, PTB
costs on the order of 28 billion dollars a year. But, this cost does not stop at the
delivery. The costs of prolonged hospital care after birth and the increased need for
hospital admission during the first year of life for ex-preterm infants is significant and
confers a large economic burden on our society.

It is well known that PTB rates in the United States are highest for Black infants (17.9%),
followed by Native Americans (14%), White infants (11.8%), and Asian infants (10%). The
specific large disparity between black and white infants is striking and the etiology of
this disparity is not fully understood. This disparity persists even after adjusting for
socioeconomic status. Maternal stress has been implicated as a potential cause of PTB.
Racism is a potent lifetime stressor in the lives of Black women in particular. It is
plausible that perceptions of racism as well as distrust in the health care system may
explain the persistent racial disparities in PTB, especially through mediation of other
factors associated with premature birth. The data to date offer a preventative strategy only
to those women with a prior PTB. These women represent a small percent of all women with a
PTB. More then half of all PTB occur in apparently low risk pregnancies. Cervical shortening
appears to be a common biological pathway leading to preterm birth, often well in advance of
PTB. Regardless of etiology of PTB, cervical change must occur. The cervix must remodel
(change) for birth to occur at any gestational age.

We hypothesize that experiences of discrimination and health care system distrust are
associated with preterm birth. Further, we hypothesize that premature cervical remodeling
occurs weeks prior to actual birth and may be able to be detected in women at highest risk
for preterm birth (nulliparous women-women who have not previously carried a pregnancy
beyond 15 weeks). This study investigates whether experiences of discrimination and health
care system distrust are associated with PTB in all women (group 1). It also investigates if
the detection of cervical remodeling (changes in the cervix measured by protein levels,
ultrasound length and physical exam) can accurately identify those women at greatest risk
for PTB-nulliparous (group 2). A prospective cohort of pregnant women will be enrolled. All
enrolled women are asked to complete validated questionnaires about experiences of
discrimination and health care system distrust. Nulliparous women are evaluated for cervical
change, through a comprehensive evaluation at 18-24 weeks. The main outcome assessed is
preterm birth.


We found this trial at
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sites
Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Philadelphia, Pennsylvania 19104
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mi
from
Philadelphia, PA
Click here to add this to my saved trials