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Preterm BirthNCT01175551

Direct Measurements of Cervical Remodeling for Predicting Preterm Birth

An observational study of Preterm Birth, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Birth
How many people
1,207 participants
Where
2 sitesUnited States
Study dates
Nov 2009to May 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: All pregnant women screened at Penn OB/GYN Associates or Helen O. Dickens Center at less than 18 weeks gestational age with a documented singleton pregnancy who agree to participate in the study (group 1); Nulliparous women (no previous pregnancy greater than 15 weeks)less than 18 weeks gestational age (group 2)

Who may be able to join

  • All pregnant women screened at < 18 weeks with a documented singleton pregnancy, who agree to participate in the study (group 1). A subset of Nulliparous women (no previous pregnancy 15 weeks)(group 2) will be assessed.
  • Women of all races and age will be included.

Who cannot join

  • Women with a multi-fetal pregnancy, current use of systemic steroids or immunosuppressive therapy or enrollment for prenatal care after 24 weeks.
  • Women with a prior documented history of Leep or Conization will be excluded.
  • Any known Mullerian anomalies such as septate uterus, bicornuate or unicornuate uterus will be excluded given that these are high risk groups for preterm delivery.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Helen O. Dickens Center for Women

    Philadelphia, Pennsylvania, 19104

  • Penn OB/GYN Associates

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
Preterm Birth
Keywords
Preterm Birth, Cervix, Cervical Shortening, Cervical remodeling, PTB
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01175551
Study groupRoleWhat they receive
Group 1women screened at Penn OB/GYN Associates or Helen O. Dickens Center with a documented singleton pregnancy less than 18 weeks gestational age
Group 2Nulliparous pregnant women (no previous pregnancy greater than 15 weeks) screened at Penn OB/GYN Associates or Helen O. Dickens Center less than 18 weeks gestational age

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm birth (delivery at less than 37 weeks)

    16-37 weeks from enrollment

    Measured: up to 42 weeks

Secondary outcomes (1)
  1. spontaneous Preterm Birth at less than 37 weeks and less than 34 weeks, small for gestational age (less than the 10% birth weight for gestational age as determined by the Alexander curve), preeclampsia and a composite of neonatal outcomes

    16-37 weeks from enrollment

    Measured: up to 42 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionNov 2011
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01175551
Sponsor's protocol ID
810707
Status last verified
Jan 2014
First submitted
29 Jul 2010
Last updated
7 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Birth, run by University of Pennsylvania at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm birth (delivery at less than 37 weeks) (time frame: up to 42 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.

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