Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia (NCT07667777) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia
Germany190 participantsStarted 2026-06
Plain-language summary
This study evaluates whether use of a cervical pessary can reduce vaginal bleeding and prolong pregnancy in women with placenta previa or a low-lying placenta. Placenta previa is a condition in which the placenta covers or lies close to the cervix and may cause serious bleeding, preterm birth, and complications for both the pregnant woman and the baby.
In this prospective, randomized, multicenter study, eligible women with singleton pregnancies and ultrasound-confirmed placenta previa or low-lying placenta between 20 and 30 weeks of gestation will be assigned either to treatment with an Arabin cervical pessary or to standard care without a pessary. The study will compare bleeding-related outcomes and pregnancy duration between the two groups.
The study is designed to determine whether a cervical pessary is a safe and effective intervention for reducing bleeding-related complications and prolonging gestation in this high-risk pregnancy population.
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:
* Age 18 to 45 years
* Singleton pregnancy
* Ultrasound-confirmed placenta previa (total or marginal) diagnosed between 20 and 30 weeks of gestation
* Or low-lying placenta with placental edge less than 20 mm from the internal os
* Written informed consent provided
Exclusion Criteria:
* Multiple pregnancy
* Fetal malformations or chromosomal abnormalities detected by ultrasound
* Uterine malformations
* Silicone allergy
* Cervical dilation
* Cervical or vaginal infection
* Cervical cancer
* Cervical tears, cervical scarring, or ectopic cervical tissue
* Preterm prelabor rupture of membranes
* Regular uterine contractions
* Cerclage in place
* Pessary already in place
* Active bleeding
* Genital prolapse grade III or IV
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
Number of Vaginal Bleeding Episodes From Randomization to Delivery
Timeframe: From randomization until delivery
2
Number of Participants Undergoing Cesarean Delivery Due to Bleeding