CompletedPhase 4

Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth

Brazil203 participantsStarted 2015-08-03

Plain-language summary

The aim of this study is to compare the effectiveness between the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervical length of 25 mm or less evaluated by transvaginal ultrasonography.

Who can participate

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: * gestational age between 20 weeks and 23 weeks and 6 days * singleton pregnancies Exclusion Criteria: * fetal death at randomization * major structural or chromosomal abnormality * cervical cerclage in the current pregnancy * preterm rupture of membranes diagnosed before randomization

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

Spontaneous preterm birth before 34 weeks of gestational age

Timeframe: before 34 weeks of gestation

Trial details

NCT IDNCT02511574

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-10

View on ClinicalTrials.gov More Preterm Labor trials

Who can participate

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.