Progesterone and Cervical Pessary in Twins (NCT03058536) | Clinical Trial Compass
UnknownPhase 2/3
Progesterone and Cervical Pessary in Twins
Brazil312 participantsStarted 2017-02-21
Plain-language summary
The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.
Who can participate
Age range
16 Years – 50 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:
* Twin pregnancy ( dichorionic or monochorionic diamniotic)
* Both fetuses alive
* Asymptomatic short cervix according to gestational age ( measurement less or equal 30 mm between 16 weeks + 0 day and 22 weeks + 0 day, less or equal 25 mm between 22 weeks + 1 day and 24 weeks + 0 day and less or equal 20 mm between 24 weeks + 1 day and 27 weeks + 6 days)
* Gestational age between 16 to 27weeks and 6 days
* Intact membranes
* Informed consent
Exclusion Criteria:
* Monoamniotic twins
* Twin Twin transfusion syndrome
* Rupture membranes
* Major malformation or chromosomal abnormality at least one fetus
* Women with Cervical cerclage in the current pregnancy
* Ballooning of membranes outside the cervix into the vagina
* Placenta previa
* Treatment with progesterone before randomization
* Allergy of the excipientes of the micronized progesterone
* Labor
* Severe hepatic disfunction, porphyria, otosclerosis, severe depression
* Use of drugs that interfere the effects of progesterone
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.