Screening To Obviate Preterm Birth (STOP)
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ClinicalTrials.gov Identifier: NCT01868308 |
Recruitment Status
:
Completed
First Posted
: June 4, 2013
Last Update Posted
: March 30, 2017
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Condition or disease |
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Preterm Labor Preterm Contractions Abdominal Cramping Back Pain Vaginal Pressure Vaginal Bleeding |
Study Type : | Observational |
Actual Enrollment : | 589 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Screening To Obviate Preterm Birth |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | June 2015 |
Group/Cohort |
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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.
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- Preterm birth [ Time Frame: Enrollment through delivery ]The primary outcome is preterm birth defined as delivery before 37 weeks.
- Early preterm birth [ Time Frame: Enrollment through delivery ]The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Women with a multi-fetal pregnancy
- Intra uterine fetal demise
- Preterm premature rupture of membranes
- Overt chorioamnionitis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868308
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Michal A Elovitz, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01868308 History of Changes |
Other Study ID Numbers: |
817085 |
First Posted: | June 4, 2013 Key Record Dates |
Last Update Posted: | March 30, 2017 |
Last Verified: | March 2017 |
Additional relevant MeSH terms:
Back Pain Premature Birth Obstetric Labor, Premature Uterine Hemorrhage Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Obstetric Labor Complications Pregnancy Complications Uterine Diseases Genital Diseases, Female Hemorrhage Pathologic Processes |