Preterm LaborSTOPNCT01868308
Screening To Obviate Preterm Birth
An observational study of Preterm Labor and Preterm Contractions, run by University of Pennsylvania at 1 site in United States.
Trial summary
Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Labor, Preterm Contractions, Abdominal Cramping
- How many people
- 589 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All pregnant women presenting to the perinatal evaluation center at the Hospital of the University of Pennsylvania with preterm labor symptoms will be approached for the study.
Who may be able to join
- Singleton pregnancy between 22- 33 6/7 weeks of gestational age.
- Must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding.
Who cannot join
- Women with a multi-fetal pregnancy
- Intra uterine fetal demise
- Preterm premature rupture of membranes
- Overt chorioamnionitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.
Read the detailed description
Preterm Birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. However, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. We propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. Specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. Through this study we hope improve risk stratification of this high risk cohort.
- Conditions
- Preterm Labor, Preterm Contractions, Abdominal Cramping, Back Pain, Vaginal Pressure, Vaginal Bleeding
- Medical subject headings
- Obstetric Labor, Premature, Colic, Back Pain, Uterine Hemorrhage
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 |
|---|---|---|
| Preterm Labor | Symptomatic women with singleton pregnancy at high risk for preterm birth between 22 - 33 6/7 weeks gestational age. We define "high risk for preterm birth" as women who present to our triage unit with complaints of preterm labor, including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, and vaginal bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
The primary outcome is preterm birth defined as delivery before 37 weeks.
Measured: Enrollment through delivery
Secondary outcomes (1)
Early preterm birth
The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.
Measured: Enrollment through delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- Michal A Elovitz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868308
- Sponsor's protocol ID
- 817085
- Acronym
- STOP
- Status last verified
- Mar 2017
- First submitted
- 29 May 2013
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening To Obviate Preterm Birth
- ClinicalTrials.gov ID
- NCT01868308
- Acronym / sponsor ID
- STOP / 817085
- Conditions
- Preterm Labor, Preterm Contractions, Abdominal Cramping, Back Pain, Vaginal Pressure, Vaginal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Jun 2013 (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.
Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.
Detailed description
Preterm Birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. However, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. We propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. Specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. Through this study we hope improve risk stratification of this high risk cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Labor | – | –Symptomatic women with singleton pregnancy at high risk for preterm birth between 22 - 33 6/7 weeks gestational age. We define "high risk for preterm birth" as women who present to our triage unit with complaints of preterm labor, including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, and vaginal bleeding. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women presenting to the perinatal evaluation center at the Hospital of the University of Pennsylvania with preterm labor symptoms will be approached for the study.
Key inclusion criteria (2 listed)
- Singleton pregnancy between 22- 33 6/7 weeks of gestational age.
- Must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding.
Key exclusion criteria (4 listed)
- Women with a multi-fetal pregnancy
- Intra uterine fetal demise
- Preterm premature rupture of membranes
- Overt chorioamnionitis
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
Time frame: Enrollment through delivery
The primary outcome is preterm birth defined as delivery before 37 weeks.
1 secondary outcome
Early preterm birth
Time frame: Enrollment through delivery
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 30 Mar 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Preterm Contractions, run by University of Pennsylvania at 1 site 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 4 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: Enrollment through delivery). 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 30 Mar 2017.