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.
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
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 group | Role | What they receive |
|---|---|---|
| Group 1 | women screened at Penn OB/GYN Associates or Helen O. Dickens Center with a documented singleton pregnancy less than 18 weeks gestational age | |
| Group 2 | Nulliparous 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.
Preterm birth (delivery at less than 37 weeks)
16-37 weeks from enrollment
Measured: up to 42 weeks
Secondary outcomes (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.
- First posted5 Aug 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Burroughs Wellcome, Bayer Droegemueller Award in Clinical Research
- Responsible party
- Principal investigator, Michal A. Elovitz, University of Pennsylvania
- Investigators
- Michal A Elovitz, MD, Principal investigator, University of PennsylvaniaSindhu Srinivas, MD, MSCE, Principal investigator, University of Pennsylvania
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Measurements of Cervical Remodeling for Predicting Preterm Birth
- ClinicalTrials.gov ID
- NCT01175551
- Acronym / sponsor ID
- 810707
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Cervix, Cervical Shortening, Cervical remodeling, PTB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,207 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Burroughs Wellcome, Bayer Droegemueller Award in Clinical Research
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –women screened at Penn OB/GYN Associates or Helen O. Dickens Center with a documented singleton pregnancy less than 18 weeks gestational age |
| Group 2 | – | –Nulliparous 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preterm birth (delivery at less than 37 weeks)
Time frame: up to 42 weeks
16-37 weeks from enrollment
1 secondary outcome
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
Time frame: up to 42 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal A Elovitz, MD principal investigator
University of Pennsylvania
Sindhu Srinivas, MD, MSCE principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
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.