Prospective Evaluation of Pathways for Preterm Birth (NCT05246579) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Evaluation of Pathways for Preterm Birth
United States240 participantsStarted 2022-02-04
Plain-language summary
This is a single center, prospective cohort study of pregnant patients at high risk for spontaneous preterm birth: patient's with history of spontaneous preterm birth, patient's with a short cervix and patient's symptomatic for preterm birth will be included. A control cohort of nulliparous patients without a short cervix will be recruited to provide baseline data. Plan to enroll 240 patients identified through our ultrasound unit with goal of 60 patients in each group.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Maternal age from 18 to 45 years of age.
* Singleton gestation.
Exclusion Criteria:
* Treatment with vaginal progesterone or intramuscular progestogen within the previous 4 weeks.
* History of congestive heart failure, chronic renal failure, or uncontrolled diabetes mellitus, or diabetes mellitus with evidence of end organ dysfunction secondary to vascular disease.
* Current pregnancy with a major fetal anomaly or known chromosomal abnormality.
* The subject has a marked uterine anatomic malformation that may alter pregnancy duration such as a septated uterus, unicornuate uterus, or uterine didelphys.
* The subject is considered not capable or unwilling to undergo study procedures and requirements.
* The subject is symptomatic with vaginal bleeding at enrollment visit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.