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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Partosure PAS


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General
Study Status Progress Adequate
Application Number P160052 / PAS001
Date Current Protocol Accepted 10/11/2019
Study Name Partosure PAS
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description 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
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%.
Data Collection 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.
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.


Partosure PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/10/2018 11/08/2018 Overdue/Received
one year report 04/11/2019 04/09/2019 On Time
18 month report 10/10/2019 10/29/2019 Overdue/Received
two year report 04/10/2020 04/08/2020 On Time
three year report 04/10/2021    
four year report 04/10/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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