Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm … (NCT05044143) | Clinical Trial Compass
CompletedNot Applicable
Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm Labor
Italy303 participantsStarted 2021-10-20
Plain-language summary
Prospective cohort study on pregnant women discharged from the hospital after the first episode of threatened preterm labor. Cervical length (CL) will be measured with transvaginal US upon initial presentation (i.e at the time of hospital admission), at the time of hospital discharge, and respectively 2, 4, 8 and 12 weeks later. Pregnant women undelivered after the 1st episode of threatened preterm labor will be invited to participate in the study if CL upon discharge is \< 25 mm. The study will investigate the potential association between cervical shortening over time and time of delivery, to assess if spontaneous preterm delivery can be predicted by CL.
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:
* Singleton pregnancy at 23+0 - 33+6 weeks' gestation
* Age \> 18 years old
* Patients should be capable of providing consent to participate in the study
Exclusion Criteria:
* Previous spontaneous preterm (20+0 - 36+6 weeks' gestation) delivery (including history of pregnancy loss due to cervical incompetence, i.e painless cervical dilatation prior to 24 weeks' gestation)
* Treatment with 17 hydroxyprogesterone caproate due to a previous spontaneous preterm delivery
* Detection of a cervical length \< 25 mm during routine ultrasound \< 24 weeks' gestation in asymptomatic patients (i.e patients that do not complain of uterine contractions or patients with no uterine contractions documented on tocometry)
* Treatment with vaginal progesterone or micronized progesterone due to a cervical length \< 25 mm
* Cerclace placement in the current or in a previous pregnancy
* Multiple pregnancy
* Age \< 18 years old
* Preterm premature rupture of membranes (pPROM) upon initial presentation
* Müllerian malformations
* Prior cervical surgery
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.
What they're measuring
1
To investigate the association between cervical length measured at different time points and the risk of spontaneous preterm birth < 37 weeks' gestation