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General |
Study Status |
Other |
Application Number / Requirement Number |
P160052 / PAS001 |
Date Original Protocol Accepted |
10/11/2019
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Date Current Protocol Accepted |
10/11/2019
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Study Name |
PartoSure PAS
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Device Name |
PartoSure test
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General Study Protocol Parameters |
Study Design |
Retrospective Cohort Study
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Data Source |
New Data Collection
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Comparison Group |
No Control
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Analysis Type |
Descriptive
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Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
This is an observational study that collects data from medical records of pregnant women presenting with signs and symptoms of preterm labor with clinically intact membranes, a cervical dilatation <3 cm, a singleton gestation between 240/7 and 346/7 weeks of gestation and tested with the PartoSure Test in routine clinical care. Results of the PartoSure Test (positive or negative) and delivery status (defined as whether a spontaneous preterm delivery (SPTD) occurred within 7 days of testing with the PartoSure Test) will be observed and assessed.
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Study Population |
The study population consists of all women who present to the clinic or labor and delivery suite who are tested with the PartoSure test and meet the following inclusion/exclusion criteria.: Inclusion Criteria: 1. Singleton pregnancy 2. Between 240/7 and 346/7 weeks of gestation 3. PartoSure test performed and test result available 4. Presentation suspicion, signs, or symptoms suggestive of pre-term labor with one or more of the following criteria: • Uterine contractions, with or without pain • Intermittent lower abdominal pain • Dull backache • Pelvic pressure • Bleeding during the second or third trimester • Menstrual-like or intestinal cramping, with or without diarrhea • Patient not feeling “right”, which may include such symptoms as general malaise, aches, and/or discomfort that are suggestive of possible preterm labor Exclusion Criteria: 1. Cervical dilatation = 3 centimeters 2. Known or suspected placenta previa 3. Cervical cerclage in place 4. Presence of moderate to gross vaginal bleeding 5. Subjects who had rupture of the fetal membranes 6. The subject has used a lubricant or antiseptic (e.g. K-Y® or Surgilube® lubricating jelly, Betadine® Cleanser) within 24 hours 7. The subject has applied a topical disinfectant (e.g. Monistat®, micanozole nitrate cream) to the vaginal area within 24 hours 8. Subjects who are less than 18 years old in jurisdictions where individuals less than 18 years old are not considered as emancipated minors
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Sample Size |
The study will enroll 4800 subjects in order to observe 168 spontaneous preterm deliveries within 7 days of PartoSure testing, assuming a prevalence of 3.5%.
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Key Study Endpoints |
PartoSure Test (positive or negative) and the patient’s delivery status, defined as whether a spontaneous preterm delivery occurred within 7 days of testing with the PartoSure Test, will be observed for each subject.
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Follow-up Visits and Length of Follow-up |
The sponsor will attempt to collect missing delivery data via follow-up telephone calls up to the point the subject reaches 39 weeks of gestation.
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