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NCT03052270 · ClinicalTrials.gov registry record · Phase 3
Arabin Pessary Combine With Vaginal Progesterone Compare With Vaginal Progesterone Alone to Prevent Preterm Delivery in Singleton Pregnancies
A Phase 3 study, sponsored by University of Illinois at Chicago.
- Terminated
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
NCT03052270 is a Phase 3 study that was terminated before completion, run by University of Illinois at Chicago. The registered enrollment target is 57 participants.
The verdict
NCT03052270, a Phase 3 study, was terminated before completion, sponsored by University of Illinois at Chicago.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
Study Summary
1. This will be a randomized prospective and open-label study with no placebo control or blinding of the participants and the research team members. The study is to compare the effectiveness of vaginal progesterone versus combination of vaginal progesterone and Arabin cervical pessary in the prevention of preterm delivery among patients with incidental shortened cervical length. 2. As part of standard clinical care, all pregnant patients usually have cervical length measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the GE ultrasound Volusion 8 using the vaginal probe. 1. Patients with short cervix will be counseled and offered the opportunity to participate in the study. 2. All participants will be taught how to use the vaginal progesterone once daily prior to bedtime. In addition, those in the combination group will have the cervical pessary placed in the clinic right away or within a week if they request for more time to brood over their diagnosis and weigh on the option of inserting Arabin pessary. 3. All participants will be followed up in the high-risk obstetric clinic as per standard prenatal care. Frequency of follow up visits will be individualized depending on patient's need and comorbidities. , Participants will be requested to bring the remnant of the vaginal progesterone to the clinic to assess compliance. 4. Participants in the study will continue their prenatal care with UIC high-risk obstetric clinic until delivery. 5. The study recruitment will occur for a period of 2 years starting from November 2016 to October 2018 or until all the anticipated numbers of study subjects have been attained. 6. There will be 10 % over-sampling to cater for those who will drop out from the study or loss to follow up after randomization, and those who delivered in another hospital. 7. Participants will have access to one of the investigators or the high- risk clinic nurse for any complaints related to their conditio
Interventions
- DRUG Arabin Pessary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-01 |
| Est. Completion | 2019-12-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03052270
The ClinicalTrials.gov registry entry for NCT03052270 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Arabin Pessary is the first listed.
NCT03052270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03052270 about?
NCT03052270 is a clinical study titled "Arabin Pessary Combine With Vaginal Progesterone Compare With Vaginal Progesterone Alone to Prevent Preterm Delivery in Singleton Pregnancies". 1. This will be a randomized prospective and open-label study with no placebo control or blinding of the participants and the research team members. The study is to compare the effectiveness of vaginal progesterone versus combination of vaginal progesterone and Arabin cervical pessary in the prevent...
What is the current status of trial NCT03052270?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2017-01. Estimated completion is 2019-12-23.
What interventions are being tested in trial NCT03052270?
The interventions under investigation include: Arabin Pessary (DRUG).
Who is sponsoring clinical trial NCT03052270?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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