UnknownNot Applicable

Pessary Versus Progesterone in Singletons

Vietnam804 participantsStarted 2020-05-01

Plain-language summary

This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm. Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.

Who can participate

Age range

18 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 pregnancies * Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7-22 0/7 weeks of gestation) * Not participating in any other study which has intervention on maternity or fetus at the same time * Provision of written informed consent to participate as shown by a signature on the patient consent form. Exclusion Criteria: * Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina * Major congenital abnormalities of the fetus * Presence of severe vaginal discharge * Presence of vaginitis or cervicitis * Presence of vaginal bleeding * Preterm premature rupture of membranes * Premature labor without ruptured membrane at the time of screening * Suspected chorioamnionitis * Unable to have cervical pessary inserted * Cerclage or pessary in place

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

Rate of preterm birth <37 weeks of gestation by any cause

Timeframe: From date of randomisation until 36 6/7 weeks

Trial details

NCT IDNCT04300322

SponsorMỹ Đức Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

Contact for this trial

Vinh Q Dang, MD

+84908225481 bsvinh.dq@myduchospital.vn

View on ClinicalTrials.gov More Preterm Birth trials